Pathogen and GMO Testing to Drive the Food Testing Market in Developing Countries

Food processing companies are increasingly turning towards food safety tests to ensure that supplies to consumers are free from all kinds of harmful pathogens. According to a new research report “Global Food Safety Testing Market Analysis,” by RNCOS, which is a market research company, the global food safety testing market is anticipated to grow stupendously in the coming years. Food safety testing refers to examination of food products for disease causing organisms, chemical residues, and other hazardous material. Food safety testing market holds a huge potential for further advancements. As globalisation of food supply heralds the globalisation of food safety, problems and solutions concerning food safety are no longer confined within the borders of a single country. Increasing public attention to microbiological hazards is also driving change in food safety industry. Rapid microbial testing is being extensively preferred all over the world, due to the advantages of accurate testing within less time.

Presently, many countries have shown their concern over food security. The governments are taking initiatives and stringent regulations have been put forward to ensure food safety in almost all the countries. The report has found that the market is presently dominated by Pathogen testing and the Genetically Modified Organism (GMO) testing. However, as the laboratories become increasingly dependent on efficient screening strategies based on both multiplex protein and the DNA screening, application of a matrix approach to determine the need for more specific identification and quantification methods will gain momentum. As a result, the GMO testing will emerge as the fastest growing segment in food safety testing market. Further, the US, Europe, Canada, China, and Japan are the major geographical markets exhibiting healthy growth rates. The study indicates that the highest growth rate in the developing countries’ food safety testing market is likely to be observed for pathogen testing, followed by GMO testing, and testing of processed food & meat products.

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U.S. Researchers Develop Rapid Diagnostic Test for Common Type of Pneumonia

University of Georgia researchers have developed a technique that can diagnose a common type of pneumonia within minutes, potentially replacing existing tests that can take several days for results. The researchers detected Mycoplasma pneumoniae, which causes atypical or "walking pneumonia," in true clinical samples with over 97 percent accuracy using a recently-developed nanotechnology- based platform. The findings were published online in the journal PLoS ONE.

"If you can make a positive identification from a 10-minute test, then appropriate antibiotics can be prescribed, limiting both the consequences in that patient and the likelihood that it will spread to others," said lead-author Duncan Krause, a professor in the department of microbiology in the UGA Franklin College of Arts and Sciences. Krause and his colleagues built upon an existing technology called surface-enhanced Raman spectroscopy, which works by detecting spectral signatures of a near-infrared laser as it scatters off a biological specimen. They were able to enhance the Raman signal by using silver nanorod arrays to detect the tiny bacteria in throat swab specimens. Krause compared the nanorod array to a brush with densely packed bristles, where each of the tiny silver rods extends out at a specific angle. The sample, such as bacteria from a throat swab, penetrates among the bristles, where the spectral signature produced by the laser is amplified and then analyzed by a computer program.

Krause noted that infections due to M. pneumoniae are very common yet difficult to diagnose. The bacterium is a major cause of respiratory disease in humans and the leading cause of pneumonia in older children and young adults."Walking pneumonia feels like a bad chest cold that will not go away,"he explained. "It can persist for weeks and even months and can cause permanent damage to the lungs if not diagnosed promptly. A delay in diagnosis extends the likelihood for complications as well as continued transmission of the infection to others." Krause said the device can be reduced to a size that could fit in a briefcase, although their testing is currently done only in a laboratory setting."Our hope is that when we begin to explore the capabilities of this technology, it can be applied in point-of- care testing,"he added."Then the impact becomes truly significant."

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Rapid Isolation of Bacteria or Specific Target Cells

ProKyma Technologies Ltd, specialists in automated sample processing techniques, has won the Innovation in Diagnostics Project of the Year at the Northwest Biomedical Awards. Presented by ThermoFisher, the award recognises the potential of the companys technology for the rapid isolation of bacteria or specific target cells in situations where there are high levels of debris such as sputum and blood. Ongoing developments for the technology include the rapid detection of Mycobacterium tuberculosis (TB) in sputum samples and the capture of Circulating Tumour Cells (CTC) in blood applications that could have an enormous impact in the diagnosis and management of these global killers.

The patented KymaSep system utilises a combination of magnetic and ultrasound forces (acousto-magnetic) to control magnetic beads in a flow-through chamber. The beads, which are coated to make them highly specific for the target bacteria or cells, can be captured and held on the side of the chamber during aggressive washing and then automatically resuspended and collected. The cells survive the process intact allowing them to be used for further analysis including microscopy and culture. Unaffected by background cells or debris, acousto-magnetic separation is suitable for a wide range of applications that have proved too challenging for traditional rapid methods, particularly those where target cells or bacteria are present in very low numbers. By processing much larger volumes than other techniques, KymaSep captures sufficient cells to produce highly concentrated samples.

There are 8.9 million new active cases of TB annually with nearly 2 million deaths, making rapid diagnosis a priority for healthcare providers around the world. ProKyma plans to develop a rapid detection test that can be used at the point of care. CTC analysis is rapidly emerging as an important tool for detecting certain cancers and monitoring response to chemotherapy. Conventional detection is complex and expensive and ProKymas technology will simplify testing and make it more accessible.

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Oshkosh Gets $1.1 Million to Help Save Great Lakes

The United States Environmental Protection Agency has awarded UW Oshkosh four competitive peer grants totaling $1.1 million in an effort to help improve the quality of Wisconsin beaches along the Great Lakes shorelines. The projects are a collaborative partnership between UW Oshkosh, private business organizations, local municipalities and other educational institutions. The projects started this year and will continue for three years. Associate Dean for the College of Letters and Sciences and environmental microbiology professor Greg Kleinheinz is the principal investigator and will lead the projects, which will provide Oshkosh students with internship opportunities. The projects started this year and will continue for three years. Kleinheinz said three of the projects, which are sanitary survey projects, have the same scope of work while the fourth project is an establishment of quantitative Polymerase Chain Reaction laboratories.

"The goal of the sanitary survey projects is to collect as much data on selected beaches in Wisconsin to look at what's causing microbial contamination," Kleinheinz said. "In order to do that staff, faculty and interns from UWO will be employed. Once we identify what the sources of microbial pollution are, some of those beaches will be chosen for beach redesign work. The ultimate goal is to prevent microbial contamination, and by doing that, we protect public health and make water quality better than it is today." Kleinheinz said the establishment of qPCR laboratories is an important step in reducing the time it takes to establish whether or not contamination is present in the water. "These are rapid tests to determine the microbial levels at the beach," Kleinheinz said. "Right now it takes 18 to 24 hours of lab time. The new methods that are coming out allow you to get results in two hours."

Traditional testing approved by the EPA takes place in several locations, including labs in Sturgeon Bay, Eagle River, Ashland and at UW-Manitowoc, according to Kleinheinz. "In a couple of years we'll move to those rapid test methods, so if you're in Wisconsin you'll be able to do a rapid test at your beach in a couple of hours which is really unprecedented," Kleinheinz said. Keeping the water safe at Wisconsin beaches is something Oshkosh student Linsi Whitman has hands-on knowledge of. Whitman, along with three other Oshkosh students, spent this past summer collecting water samples from 34 public beaches in Door and Kewaunee counties. Whitman said the work she and her fellow students did has had a great impact on the local communities. "This is a benefit to the community because, after the BEACH (Beaches Environmental Assessment and Coastal Health) Act, public beaches that surround the Great Lakes need to be monitored for acceptable water quality," Whitman said. "In addition, during the summer, families are able to check the status of the beaches online or by calling the health department of their county. This allows families to ensure that their loved ones are swimming in water with minimal contamination." Whitman said her internship has taught her that there is more to checking water for contamination than one might expect.

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Green Light for Rapid TB Test

The World Health Organisation has approved a new rapid test for Tuberculosis (TB) and drug-resistant TB that will lead to results being available within 100 minutes. Using the rapid test health workers can make an accurate diagnosis of TB within 100 minutes compared to current methods that require patients to wait up to 48 hours for straightforward TB results and weeks for drug-resistant tests. Patients often die while waiting for these results, are lost to follow-up or go on to infect others while they wait to be placed on treatment.

Current treatment standards in most countries require of patients to give sputum at least twice after which sputum smear microscopy is used to make the diagnosis - a development that is more than a century old. If the result is positive the patient is put on treatment. Sputum smear microscopy is not always accurate especially in HIV-positive patients. Dr. Mario Raviglione, director of WHO's Stop TB Department said the new test was a major milestone in global TB diagnosis and care.

The WHO's stamp of approval for the rapid test comes after 18 months of painstaking testing to verify its effectiveness in diagnosing pulmonary TB and more difficult forms including drug resistant TB and TB aggravated by HIV. Implementing the fully automated NAAT (nucleic acid amplification test) could result in a three-fold increase in the diagnosis of patients with drug-resistant TB and doubling in the number of HIV associated TB cases in areas with high TB and HIV.

Added to the stamp of approval is a call made by the WHO for the easy to use rapid test to be rolled out as far and wide as possible under clearly defined conditions. It would be part of the national plans for TB and MDR TB care control. One of the key concerns has been affordability. The Foundation for Innovative and New Diagnostics, a co- developer, announced that it had negotiated a 75 percent price reduction with the manufacture, Cepheid for the benefit of countries most affected. Favourable pricing will be granted to 116 low and middle income countries with a high burden of TB as well as an additional reduction in price if there is high demand for the test. Dr. Giorgio Roscigno, FIND's chief executive officer said, there was a strong commitment to overcome all the barriers including those posed by money. "For the first time in TB control, we are enabling access to state-of-the-art technology simultaneously in low, middle and high income countries. The technology also allows testing of other diseases, which should further increase efficiency."

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Scientists to Develop New Rapid Test in Fight Against Sexually Transmitted Infections

Scientists from the University of Southampton have secured funding to develop an ultra-rapid sexually transmitted infection (STI) detection system for clinics that can detect STIs in under 15 minutes. The Client (Clinic-based Infection Examination through Nucleic acid Technologies) detection system will use short fluorescently-labelled DNA sequences, called HyBeacons®, that are able to detect sections of DNA sequence with a genetic variation that identify the presence of an STI. The technologies are being developed by scientists from LGC, a leading chemical and biological analytical services and reference materials company, working in collaboration with the University of Southampton and OptiGene, who will refine and manufacture the desktop amplification device and assay (a test to find and measure the amount of a specific substance) for rapidly testing genetic markers for detection of STIs.

The project brings together researchers from across the University of Southampton with interests in development of novel molecular probes (Professor Tom Brown from the Faculty of Natural and Environmental Sciences), the biology of chlamydia (Ian Clarke, Professor of Molecular Microbiology from the Faculty of Medicine) and development of point-of care molecular testing (Dr John Holloway from the Faculty of Medicine). Professor Ian Clarke says: "The combination of LGC and OptiGene together with the University of Southampton is a unique partnership between industry and academia. It brings together the critical components necessary for the development of a novel, sensitive, accurate and extremely rapid point of care test that will revolutionise STI diagnostics." Professor Tom Brown is working with LGC to produce a new generation of more powerful fluorophore molecules (a component of a molecule which causes it to be fluorescent) to enable the HyBeacons® probes to detect STIs with greater accuracy and speed. The Chlamydia Research Group, based in the University's School of Medicine who work closely with the HPA regional laboratory based at Southampton General Hospital, will use universally-conserved sequences from sexually transmitted bacteria as a basis for developing the Client tests. This team will also lead the collaboration in the design of the Client testing kits.

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Food Safety Testing Market to Experience Strong Growth

MarketResearch.com has announced the addition of RNCOS's new report, "Global Food Safety Testing Market Analysis," to their collection of Food & Beverage market reports. Food safety testing refers to examination of food products for disease causing organisms, chemical residues, and other hazardous material. Food safety testing market holds a huge potential for further advancements. Food processing companies are increasingly turning towards food safety tests to ensure that supplies to consumers are free from all kinds of harmful pathogens. As globalization of food supply heralds the globalization of food safety, problems and solutions concerning food safety are no longer confined within the borders of a single country. Increasing public attention to microbiological hazards is also driving change in food safety industry. Rapid microbial testing is being extensively preferred all over the world, due to the advantages of accurate testing within less time.

According to the new research report, "Global Food Safety Testing Market Analysis," the global food safety testing market is anticipated to grow stupendously in the coming years. Presently, many countries have shown their concern over food security. The governments are taking initiatives and stringent regulations have been put forward to ensure food safety in almost all the countries. The report has found that the market is presently dominated by Pathogen testing and GMO testing. However, as the laboratories become increasingly dependent on efficient screening strategies based on both multiplex protein and DNA screening, application of a matrix approach to determine the need for more specific identification and quantification methods will gain momentum. As a result, GMO testing will emerge as the fastest growing segment in food safety testing market. Further, the US, Europe, Canada, China, and Japan are the major geographical markets exhibiting healthy growth rates. Our study indicates that the highest growth rate in the developing countries' food safety testing market is likely to be observed for pathogen testing, followed by GMO testing, and testing of processed food & meat products.

The report provides extensive information and rational analysis of the global food safety testing market. It has thoroughly examined current market trends, industrial developments, and competitive landscape to enable clients understand the market structure and its progress in coming years. The report also provides an insight into the segment-wise market trends along with an analysis of the regional level to provide an overview of developments taking place across the world.

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Particle Measuring Systems Introduces a Real-Time Microbial Monitor

Particle Measuring Systems introduced their innovative instrument, the BioLaz™ Real-Time Microbial Monitor for rapid detection of airborne biological organisms in controlled environments. The BioLaz™ Real-Time Microbial Monitor offers immediate notification when biological particles are present and real-time verification of biological activity levels during filling operations. This results in faster batch releases, revolutionizing sterile manufacturing processes.

As process air passes through the system, the BioLaz™ Real-Time Microbial Monitor illuminates particles in the sample. If biological particles are present, the organisms fluoresce and are counted in real-time. This system can easily be integrated into new or existing facility monitoring systems and reduces operator errors inherent when standard growth-media methods are employed.

The BioLaz™ Real-Time Microbial Monitor has been independently tested to meet the rigorous requirements of USP Validation of Alternative Microbial Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality. Additional features include an internal pump, which eliminates the cost and need for an external vacuum system, and a small footprint in a 316L stainless steel enclosure.

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bioMerieux and Biocartis Sign Strategic Partnership in Molecular Diagnostics

bioMerieux and Biocartis announced today that they have entered into a strategic agreement to co-develop assays on Biocartis' fully integrated molecular diagnostics system, which the two companies will co-distribute starting in 2012. Biocartis has continued to successfully develop its molecular diagnostics platform, which was acquired from Philips earlier this year. The platform now fully integrates all the steps of a multiplexed molecular assay, from sample-in to data-out, in a sealed disposable cartridge, which avoids any contamination risk. Providing rapid results, the system is able to perform complex tests on a wide variety of samples, including oncology assays on tissue. The Biocartis platform does not require molecular biology experience or infrastructure with highly skilled technicians, and involves only 1-2 minutes hands-on time. bioMerieux will enhance the Biocartis platform's broad menu with an exclusive line of tests for healthcare-associated infections and sepsis. bioMerieux also plans to develop oncology and theranostics assays on the system.

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Free Trial Offer: ampliPHOX Colorimetric Detection Technology for Low-Density Microarrays

InDevR, developer of advanced life science products, announced that it is seeking scientists interested in participating in extensive beta site testing of its ampliPHOX Colorimetric Detection Technology for low density microarrays. Based on the overwhelming success of initial beta site testing, InDevR plans to significantly expand testing by offering a free trial kit (instrument and reagents) to scientists currently working with low density microarrays or assays that utilize biotinylated targets immobilized on transparent substrates.

InDevR's ampliPHOX detection technology is an innovative new colorimetric detection method based on light-initiated signal amplification through polymerization. The field portable and inexpensive ampliPHOX Reader both initiates the signal amplification process and collects a digital image of the result. In addition, the ampliVIEW software is capable of automatic image interpretation, providing the user with immediate results. The ampliPHOX technology is a rapid and inexpensive alternative to traditional fluorescence-based microarray detection methodologies.

"Early feedback from collaborators that have tried ampliPHOX has been enthusiastic -- they love the simplicity, sensitivity, and affordability of the system. We want to solicit broad-based feedback from the community by placing 50 trial kits with scientists looking for alternatives to more expensive or complicated detection technologies," said Dr. Kathy Rowlen, CEO of InDevR. Scientists interested in evaluating ampliPHOX detection should register for a free trial on the InDevR website.

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Lonza microCompass™ Molecular Assays on the BD Max™ System

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), and Lonza Group Ltd announced that they have entered into an exclusive licensing and collaboration agreement for Lonza to commercialize its microCompass™ molecular assays on the BD MAX™ System. Lonza has the exclusive worldwide license to co-market the BD MAX™ System with the complete microCompass™ product line in selected fields. The microCompass™ assays on the BD Max™ system will provide an automated platform with same day results for quality control testing in the Pharmaceutical and Personal Care Products market segments. BD and Lonza are also developing and optimizing automated rapid microbial testing solutions that are easy to use with true 'load and walk away' functionality.

The BD MAX™ System is based on microfluidics and molecular biology technologies, which fully automate nucleic acid extraction/recovery, polymerase chain reaction setup, amplification and detection. The microCompass™ assays will facilitate rapid detection for total bioburden load, sterility testing, Mycoplasma, and a variety of specific organisms. The microCompass™ reagents are designed to be flexible for ongoing assay development and menu expansion to meet global and manufacturing sites' unique needs. Combined, this novel system provides quality control personnel with a rapid and accurate testing solution. This contributes to improved control, quality and efficiency in the manufacturing and overall product release process within the Pharmaceutical and Personal Care markets.

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Microbial Assessment of Finished UHT and ESL Products Reduced to 36 Hours

Charm Sciences´ EPIC system provides rapid microbial assessment of finished UHT and ESL dairy and dairy substitute products. Recent advances have reduced the incubation time from 48 to 36 hours for most products. The EPIC (End Product Indicator Charm) system´s faster 36-hour incubation helps manufacturers remediate possible contamination concerns, reduce process line down time and release safe product more quickly.

"EPIC is being used by manufactures of dairy products, soy milk, rice milk, almond milk, soups, broths, and nutraceutical beverages around the world," said Donna Stearns, EPIC Product Manager at Charm. "We are excited to provide current and new customers with a faster test which can enhance food safety, and help manufactures increase operational efficiencies and reduce warehouse costs." EPIC provides a sensitive presence/absence test for microbial ATP, a bio-marker of microbiological quality. Test results are captured and stored in real-time with EPICLink software allowing for further trend analysis.

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FDA Announces Plan to Launch "Regulatory Science" Initiative

The Food and Drug Administration (FDA) has issued a report titled “Advancing Regulatory Science for Public Health,” that outlines the agency’s plan to develop new scientific and technological tools, standards and approaches to improve its ability to assess the safety, efficacy, quality, and performance of FDA-regulated products, including foods and tobacco. FDA expects to use President Barack Obama’s $25-million increased budget request for fiscal year 2011 to expand the initiative and “build additional partnerships with academia, industry and government around the country.” According to a news source, FDA’s budget has been frozen under a continuing resolution Congress passed before taking its latest recess.

A new office dedicated to regulatory science will be created, and the initiative’s goals include protecting the food supply by focusing on “the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for contaminants at once. In addition, FDA must enhance the scientific understanding of the causes of food-borne illness so that feasible interventions can be designed and implemented to effectively reduce risk.” The report refers to other opportunities “to advance regulatory science to improve food safety,” such as (i) “Developing effective tools and strategies for sampling, testing and analysis,” (ii) “Tracking Salmonella in the food supply,” (iii) “Preventing microbiological hazards,” (iv) “Responding to food-borne illness,” (v) “Controlling toxins,” and (vi) “Monitoring antibiotic resistance in food-borne pathogens.”

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New Market Report States RMM Usage in the Pharma and PCP Sectors Will Double

Strategic Consulting, Inc.
318 Prosper Road
Woodstock, NY 05091
phone: +1 802-457-9933
mobile: +1 802-291-0134
email: weschler@strategic-consult.com
website: www.strategic-consult.com


According to a new market research report from Strategic Consulting, Inc., the global Pharmaceutical (Pharma) and Personal Care Products (PCP) Sectors conducted more than 530 million microbiology tests last year, which resulted in a market value of over $1.8 billion for these tests.

Pharma/PCP—2nd Edition is a follow-on report to the original report published in 2004. As with the first edition, this new report provides detailed information about testing practices for both of these Sectors covering:

• What type of samples are collected
• Which organisms are tested
• A review of the methods used for analysis
• Current and projected microbiology testing volumes and market values based on existing and potential new technologies are also provided

A key aspect of this Report is the spotlight on the utilization of rapid microbiological methods (RMMs) in each of these Sectors. The PCP Sector has been more aggressive with the adoption/usage of RMMs and this should continue over the next five years. The Pharma Sector, while using more than in the past, lags be-hind the PCP Sector in RMM test volumes. The Report thoroughly examines the similarities and differences related to RMM utilization today and projects these patterns forward for five years. In addition, testing patterns and approaches within subsets of each of these Sectors are discussed. The Report examines differences between classic Pharma and Biopharma company approaches to RMMs as well as global PCP companies in comparison to regional and contract manufacturer PCP companies.

The Report is based on two primary market research efforts:

• Extensive telephone interviews with Pharma and PCP plant QA/QC personnel
• In-depth interviews with key opinion leaders and senior/leading quality experts/management (collectively referred to as KOLs) from the Pharma and PCP Sectors

In the interviews with the KOLs, the following topics were thoroughly explored:

• Do you use rapid tests/systems? If so, where and why?
• Do current RMMs meet your needs?
• What improvements would you like to see?
• Would these improvements broaden RMM use?
• Is there a clear best RMM system out there now?
• What are the key organisms and applications for rapid?
• What are the hurdles for RMM adoption at your company?
• What are your predictions for RMMs over the next 5 years?

These KOLs provided a rich and personal understanding of their own experiences with RMMs. In some cases the KOLs are thoroughly pleased with their accomplishments and see broader usage in their Sector. In other cases, the KOLs recognize and speak to the mismatch between technology and their needs. The KOLs also provide candid comments about current RMMs.

In addition, the Report provides business summaries of 15 diagnostic companies involved with RMMs for the Pharma and PCP Sectors. Included in these summaries are insightful comments by the KOLs regarding their experiences with these products and companies.

Pharma/PCP—2nd Edition thoroughly reviews current testing practices in these two Sectors. A fundamental conclusion is that RMM usage is expected to continue to grow as current applications make further penetration and as new applications are added:

• Pharma and PCP Sectors conduct an extensive amount of testing and are #2 and #3 Sectors based on test volumes in the industrial market (Food being #1)
• Testing and market value is growing....driven by regulations and protection of brand names
• There have been recalls impacting key players in these sectors, which only heightens testing
• The use of RMMs is increasing steadily in each Sector but there are major differences regarding adoption patterns and uses
• In 5 years, RMM usage is expected to more than double but this could be impacted on the upside significantly if new technologies have a better fit, and more versatility.

For further information on the Pharma/PCP—2nd Edition Report please contact Tom Weschler at Strategic Consulting, Inc. by phone (802-457-9933), email (weschler@strategic-consult.com), or by visiting their website at www.strategic-consult.com.

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Pall Corporation’s New GeneDisc® Rapid Microbiology System Advances Quality Assurance Analysis

Pall Corporation
25 Harbor Park Drive
Port Washington, New York 11050
toll free phone: 1-800-521-1520
fax: 516-801-9754
email: genedisc@pall.com
website: http://www.pall.com/biopharm_53215.asp

Pall Corporation, a global leader in filtration, separation and purification, today announced the introduction of the GeneDisc® Rapid Microbiology System for advanced microbial quality monitoring. This system represents Pall’s latest quality assurance innovation for the pharmaceutical manufacturing industry.


“The GeneDisc Rapid Microbiology System represents a leap forward for applications of rapid microbiological analysis in the pharmaceutical manufacturing setting,” says Ken Frank, President of Pall Life Sciences Biopharmaceuticals division. “This reliable, simple to use, and robust platform represents a significant time savings over traditional incubation sampling methods and can allow materials and final products to be released more quickly, improving production efficiency and reducing inventories.”

Typical culture-based methods may need at least five days to produce results. Pall’s GeneDisc System generates comparable results for most microbiological applications in just a few hours. The advantage provided by the GeneDisc System shortens the manufacturing cycle for pharmaceutical manufacturers, reducing warehousing costs, improving product time to market, and increasing ROI throughout the production process. The GeneDisc Rapid Microbiology System represents Pall’s first step in providing a complete qPCR platform for rapid microbiology analysis.

The GeneDisc Rapid Microbiology System is efficient and easy to use. Its novel, highly simplified technology, based on bar-coded data input and fewer operator-dependent steps, ensures reliable results that significantly reduce the risk of user error. The economic design of the GeneDisc System also offers the unique advantage of moving assays to an operator with relatively modest training, freeing up technically skilled staff for more demanding duties.

This new application in Pall’s GeneDisc product group is based on established quantitative polymerase chain reaction (qPCR) technology, which provides a simple, rapid tool for microbiological analysis. This single-protocol solution yields highly reproducible results with simplicity, speed and security, enabling quality control testing to be executed on a much shorter timetable than by using traditional methods.

The first of these assays is a Specified Microorganism Test, which simultaneously detects indicator pathogens as required by Pharmacopeia. Results are obtained within hours and not the several days required by traditional microbiology methods. Additional assays are planned that will further expand the GeneDisc System to perform accelerated microbiological testing during various stages of pharmaceutical and biotech production.

“Typical methods of sample analysis often require three to five days to detect contamination,” says Dr. Peter Ball, Technical Marketing Director for Pall Life Sciences. “That can mean scrapped or reworked product, which represents considerable risk and cost. With the GeneDisc System, we can reliably eliminate those production risks in just a few hours,” Ball says.

Amelia G. Tait-Kamradt, a Scientist at Pfizer, Inc., will present, “Using a Novel qPCR Platform to Accelerate Pharmaceutical Microbiology Testing,” a whitepaper highlighting the advantages of the GeneDisc System at the Parenteral Drug Association’s 5th Annual Global Conference on Pharmaceutical Microbiology, October 26, in Washington, D.C. For more information on the GeneDisc Rapid Microbiology System or any of the other Pall Corporation life sciences solutions, visit www.pall.com/biopharm.

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Enterolert®-DW for Drinking Water Detects and Quantifies Enterococci in 24 Hours

IDEXX Laboratories, Inc., have announced the European launch of Enterolert®-DW for the detection of Enterococci bacteria in drinking water. The new test exceeds both the speed and the accuracy of conventional testing methods. European regulations require testing for enterococci in drinking water, as well as for coliforms and E. coli. All are indicators of possible water contamination that could pose a health risk to humans. The Enterolert-DW test provides results in just 24 hours, compared to the two days needed for conventional testing.

The new method includes ready-to-use reagents and requires only one minute of hands-on time, making it easier to use when compared to the conventional testing method (ISO 7899-2, also known as the “Slanetz and Bartley method”). The conventional method requires a technician to filter the water through a membrane, place the membrane on an agar plate to grow the bacteria for 2 days, transfer the membrane to another agar plate for confirmation, and then count bacterial colonies.

The Enterolert-DW test uses the same equipment and test procedure as the popular IDEXX Colilert®-18 water test for coliforms and E. coli. This means that laboratories and public utilities can now use a single platform for all their key microbial drinking-water tests and produce accurate and complete drinking water test results in just 24 hours.

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Techne Develops the World's Smallest Gradient Thermal Cycler

Part of the Techne range of personal thermal cyclers from Bibby Scientific, the TC-3000G gradient model offers two interchangeable block options, a gradient of up to 15ºC, an exceptionally wide choice of consumables, fast-track programming and networking capability. All these features and more are contained within a 17 x 33 cm footprint, making this the world's smallest gradient thermal cycler. The TC-3000G gradient thermal cycler's 48-well thermal block is arranged to provide eight columns for testing eight different temperatures simultaneously, and six rows for optimising reagents such as MgCl2 and primer concentrations. The alternative thermal block option holds 30 x 0.5 ml tubes - significantly more than the usual 12 or 20 tubes of this size.

The TC-3000G has been designed to hold half a 96-well plate in a horizontal format, so that a wider range of temperatures can be applied and any protocol optimised within a single experiment. The latest software enables a gradient to be added to any temperature step of the program. The heated lid of the TC-3000G is temperature selectable and also fully height-adjustable. This feature gives users the widest possible choice of consumables, including Techne's 24 and 48-well plates and 8-tube strips, adding to the unit's versatility. Operation of the TC-3000G is intuitive, with speed dial functionality allowing fast program location. The gradient calculator function displays the temperature for each of the eight columns, ensuring easy replication of thermal conditions. Annealing temperatures, at which primers bind to DNA templates, can be optimised over a 15 °C gradient between 20 and 80 °C, and the heating rate of 3.3 °C per second is the fastest of all 48-well cyclers in the market, including gradient units. Utilising the USB connection, one standalone unit or up to 32 cyclers networked together can be controlled by Techne's free Gensoft PC software.

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bioMérieux Gains International Approval for its Automated 'Next Day' Solution: VIDAS® Listeria Xpress

bioMérieux have announced that VIDAS® Listeria Xpress (LSX), an automated test for the fast detection of Listeria species, has been granted Official Methods of Analysis (OMA) approval by AOAC INTERNATIONAL on a wide variety of food products. This added level of certification assures VIDAS LSX users that the test meets stringent AOAC standards for excellence in pathogen detection. As part of the VIDAS Next Day range, VIDAS LSX has previously received AOAC-RI (Research Institute) validation for food production environmental samples, and is certified by AFNOR Validation according to the ISO 16140 standard. bioMérieux's expertise in both immunoassays and microbiology resulted in the creation of a high performance solution to detect Listeria species in less than 30 hours, faster than most of the other automated methods. For this test, bioMérieux developed a specific enrichment broth (LX broth) to boost the growth of Listeria species.

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New Greenlight Screening System for Same-day Bacterial Counts in Food

MOCON, Inc. is introducing a new screening system for same-day bacterial detection in food. The new GreenLight™ series significantly reduces the testing time and labor needed to determine aerobic bacterial counts in meat, poultry, seafood, dairy, produce, etc. Processors and packers get accurate results and improve speed to market in a cost-effective manner.

The GreenLight™ series provides a total viable count (TVC) or aerobic plate count (APC) of a food sample´s microbial load by using a sensing assay or vial. As bacteria in the test sample multiply and respire, they consume oxygen. The change in oxygen is used to calculate the original sample´s colony forming units per gram (cfu/g) for solids or per milliliter for liquids.

The development of this new, leading-edge technology has been made possible via MOCON´s investment in Luxcel Biosciences Limited (Luxcel), Cork, Ireland, which was announced earlier this year. At the time, MOCON stated that as part of its initial post-investment activity, it would dedicate some of its research and development resources to help bring a high-throughput pathogen (Listeria, Salmonella, E. coli, etc.) screening process to the food industry. The GreenLight™ series is part of that initiative.

The GreenLight™ series is making its debut with two models—the 910 and 960. The Model 910 is compact and easy to use. It targets smaller labs and processing areas. The Model 960 has been designed for larger labs which require higher throughput. The system is extremely flexible and utilizes a standard plate reader format which can be automated. It can test 96 or 384 well plates in either a pass/fail or absolute mode. The Model 960 has a throughput potential of 1 to 384 absolute tests in one day.

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NanoLogix Quick-Tests Detect and Identify Live Bacteria with Improved Accuracy and Speed

NanoLogix, Inc. have introduced the new Quick-Test product line for detection and identification of aerobic live-cell bacteria. With the NanoLogix Quick-Tests, the research community will be able to obtain high-sensitivity analysis results in reduced time with lower costs than traditional technologies. The new NanoLogix Quick Test product line complements the Company´s existing BNP and BNF membrane and filtration technologies with a projected market of medical laboratories, food and beverage producers, pharmaceutical, university and other institutional users.

The NanoLogix Quick-Tests detect and identify a multitude of live-cell bacteria, such as E.coli, Salmonella, and Listeria, with the additional capability of rapid identification of yeasts. After a shortened incubation period the ultra thin membrane is transferred to a staining plate where micro-colonies become visible after capillary action through the membrane brings the staining agent into contact with the micro-colonies. The results can be obtained in as little as a quarter of the time of conventional methods, in concentrations potentially as small as a single cell.

Each Quick-Test kit is designed to provide results for fifty individual tests of the targeted bacteria and each test kit is identified by the name of that specific bacteria, e.g., E.coli Quick-Test , Salmonella Quick-Test, etc. NanoLogix currently has Quick Tests available for E.coli, Salmonella, and Listeria with additional bacteria Quick-Tests available upon request.

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BJS Biotechnologies Launches Rapid Next-Generation Thermal Cycler

BJS Biotechnologies is launching its new rapid next-generation thermal cycler, UF1, at Biotechnica 2010, in Hannover, Germany (5-7 October 2010). UF1 increases the speed of DNA amplification by up to ten-fold, opening up opportunities for the use of PCR in Point-of-Care diagnosis. Thermal cyclers raise and lower the temperature in PCR, breaking the DNA strands apart and promoting DNA replication. These traditionally use a heat exchange block to warm and cool DNA samples in plastic tubes or microtitre plates, but this can result in slow and uneven temperature changes, and exact temperature control is vital for fast and efficient DNA amplification and accurate and consistent results.

The UF1 thermal cycler uses a low-cost single-use, recyclable consumable that combines the microtitre plate, heat exchange block, and attached heaters. This puts the DNA samples in direct contact with the heating element, resulting in rapid and controlled temperature changes, at up to seven cycles per minute. The disposable plate is simple to use, decreasing user error, eliminates the time and cost involved in cleaning, as well as reduces the risk of cross-sample contamination. “Current real-time PCR thermal cyclers are both expensive and slow. We developed the technology because we had become frustrated with the limited power and heat, as well as the lack of thermal uniformity, from cyclers using the Peltier effect devices,” says Ian Gunter, R&D Director, BJS Biotechnologies.

“UF1 provides reliable and reproducible results within five to six minutes, compared with one to two hours for thermal cyclers that rely on heat exchange. This means that one machine could do the work of ten, freeing up bench space and increasing laboratory productivity,” says Richard Lewis, Managing Director, BJS Biotechnologies. UF1’s process speed means that it has potential in situations needing rapid diagnoses, for example at Point-of-Care in epidemics such as foot & mouth or swine flu, or for detecting MRSA infections in hospital A&E settings. Other applications could include biopsies, identification of water-borne disease, detection of micro-organisms in biological warfare or bio-terrorism, and tracking contamination in the food manufacturing industry, as well as pharmacogenomics in personalised medicine. BJS Biotechnologies is in discussion with a number of European distributors, and UF1 will be rolled out across Europe in early 2011, beginning in the UK.

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MIT to Conduct a Webinar Demonstrating the Ease of Use and Efficiency of Its Bacteria Identifying MIT 1000 System

Micro Identification Technologies, Inc. will conduct a Webinar later this month on the operation of the MIT 1000 Rapid Microbial Identification System. The objective of the Webinar is to demonstrate the speed and operational simplicity of performing bacteria identification (ID) tests using the MIT 1000 System and to give a brief education on the non-biological light scattering technology that is used to obtain an ID. The Webinar will be conducted by MIT's Chief Technical Officer, Dr. David Haavig and will be open to all of those interested in learning more about the Company's System. "Using our patented light scattering technology for this application only became economically feasible with the creation of high speed personal computers that are needed to compile and analyze the vast amount of data collected in the ID process.

The Webinar will highlight our unique ability to conduct an ID test in less than 5 minutes at a cost of 10 cents per test. These attributes position MIT to contribute significantly to the fight against widespread food contamination events," stated Michael Brennan, MIT's Chairman and CEO. MIT has demonstrated the ability to detect and identify, within several minutes, the microbes Escherichia coli, Listeria, Salmonella, Staphylococcus aureus, and other pathogenic bacteria. MIT has performed over 300 tests for the identification of the aforementioned contaminants and scored 95% accuracy. The System can currently identify 23 species of bacteria and is easily expandable. The identification process has been verified by North American Science Associates, Inc. (NAMSA), an independent, internationally recognized biological testing laboratory.

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Ultra-rapid Next-generation Thermal Cycler Improves PCR

BJS Biotechnologies has launched its new rapid next-generation thermal cycler, UF1. UF1 increases the speed of DNA amplification by up to ten-fold, opening up opportunities for the use of PCR in Point-of-Care diagnosis. Thermal cyclers raise and lower the temperature in PCR, breaking the DNA strands apart and promoting DNA replication. These traditionally use a heat exchange block to warm and cool DNA samples in plastic tubes or microtitre plates, but this can result in slow and uneven temperature changes, and exact temperature control is vital for fast and efficient DNA amplification and accurate and consistent results. The UF1 thermal cycler uses a low-cost single-use, recyclable consumable that combines the microtitre plate, heat exchange block, and attached heaters. This puts the DNA samples in direct contact with the heating element, resulting in rapid and controlled temperature changes, at up to seven cycles per minute. The disposable plate is simple to use, decreasing user error, eliminates the time and cost involved in cleaning, as well as reduces the risk of cross-sample contamination. UF1 provides reliable and reproducible results within five to six minutes, compared with one to two hours for thermal cyclers that rely on heat exchange. This means that one machine could do the work of ten, freeing up bench space and increasing laboratory productivity.

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BD Diagnostics and Bruker Collaborate to Improve Microbial Identification and Antimicrobial Susceptibility Testing

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), and Bruker Daltonics Inc., a subsidiary of Bruker Corporation, announced an international co-development and co-marketing collaboration that will promote an emerging, integrated approach to bacterial and fungal identification and antimicrobial susceptibility testing. This new approach has the potential to transform how traditional microbiology has been performed for decades. Through this collaboration, identification of microorganisms will be performed with the Bruker MALDI Biotyper, a mass spectrometry-based proteomic "fingerprinting" system specifically configured for rapid identification of bacteria, yeast and fungi. The MALDI Biotyper is available in a clinical version with IVD-CE mark in Europe and is for research use only (RUO) in the United States, where Bruker intends to seek FDA clearance.

BD and Bruker intend to combine the MALDI Biotyper microbial ID system with automated antimicrobial susceptibility testing on the BD Phoenix(TM) Microbiology System. The BD EpiCenter(TM) Microbiology Data Management System, which will manage patient data from both the identification and the susceptibility test systems, will facilitate this industry-first integrated approach. The MALDI Biotyper -- BD EpiCenter software integration will be further developed to optimize workflows for rapid MALDI Biotyper pathogen identification directly on positive blood cultures from the leading BD BACTEC(TM) blood culture system. This rapid blood culture-to-ID workflow is supported by Bruker's new MALDI Sepsityper® consumables kit, which today is for RUO. It is expected to become clinically important in the future, as time-to-result for pathogen identification is critical to management of patients having potentially serious bloodstream infections or sepsis. Microbial identification and antimicrobial susceptibility testing is the end-point of the major work a microbiology lab performs on a daily basis. After culturing and isolating bacteria and fungi from patient specimens, organisms need to be identified and tested to determine which drugs will inhibit or stop their growth.

The Bruker MALDI Biotyper allows highly accurate, rapid and cost-effective identification through a process in which organisms are identified by the unique spectrum of the major proteins and peptides that constitute their makeup. The accuracy and benefits of the MALDI Biotyper have been well documented in over 30 peer-reviewed articles. Antimicrobial susceptibility testing is conducted via traditional automated systems such as the BD Phoenix System. The combination of the two leading technologies, the BD Phoenix System and the MALDI Biotyper, and the data management through the BD EpiCenter System, will provide laboratorians with a groundbreaking new approach to identification and susceptibility testing, which will reduce the turnaround time for critical diagnostic results, while also improving laboratory efficiency and costs.

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Life Technologies Launches Next-Generation, High Throughput Microbial Identification System for Environmental Monitoring within Pharmaceutical Manufacturing

Life Technologies Corporation announced the launch of its next-generation, high throughput genotypic MicroSEQ® Rapid Microbial Identification System for the identification of bacteria and fungi within a pharmaceutical manufacturing environment. Powered by the new 3500 Series Genetic Analyzer, this new system offers enhanced throughput, ease-of-use features while maintaining the accuracy required by the pharmaceutical industry to rapidly identify microbial contaminations.

Contaminant analysis is important because harmful bacteria and fungi can contaminate product, raw materials and production facilities. Environmental monitoring is an important step in the detection and identification of microbial contamination in pharmaceutical manufacturing facilities, which may result in shutdowns, costly delays, or reduced productivity. Currently, regulatory guidelines include a monitoring program for bacteria and fungi in production facilities. Many microbiologists believe that genotypic methods deliver more accurate and precise results than traditional biochemical and phenotypic techniques. First introduced to the Pharma industry in 2004, the MicroSEQ Microbial Identification System is based on genotypic-based identifications, today’s gold standard in identification of bacteria and fungi. "DNA-based amplification and sequencing results are faster, more sensitive, more accurate and more reproducible than current microbiological methods," said Dr. Robert Johnson, Director of Dialogue in Switzerland.

The new MicroSEQ Rapid Microbial Identification System is designed to increase efficiency in set-up, run-time and maintenance scheduling while sustaining the high level of accuracy enjoyed by current users. Reduced sample preparation steps, plug-and-play consumables, higher capacity instrumentation and user-friendly software help enable up to a 20% reduction in process-run time. The system’s libraries include more than 3,000 fully validated bacterial and fungal species, currently the life science industry’s largest and most comprehensive collection. Additionally, the system’s accuracy can deliver a measurable financial impact through the reduction in the amount of re-testing, or outsourcing of identifications for hard-to-identify microbial contaminants.

It is this continued commitment to providing leading-edge technology that has MicroSEQ placed at many of the top pharmaceutical companies worldwide. "The MicroSEQ ID system is the standard for microbial identifications in pharma today due to its accuracy and throughput," said Tony Hunt, General Manager of Pharma Analytics at Life Technologies. "With the introduction of MicroSEQ Rapid, we continue to address the needs of microbiologists in product quality and safety testing."

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MIT Production Start-Up Is on Track and Poised to Significantly Reduce Widespread Food Contamination

Micro Identification Technologies, Inc. announces that its plans to start production of the MIT 1000 System remain on-track to begin later this year. Critical sub-system electronics were successfully tested and the remaining tasks that include the build and test of the first production System present no additional challenges for MIT and its contract manufacturer, OSI Optoelectronics. In addition, it was recently announced that 8500 pounds of beef were recalled due to E.coli contamination. The strain of E.coli causing the contamination was a shiga toxin-producing E.coli (STEC) known as E.coli O26 that many people believe should be classified as an adulterant (contaminant). Food Safety and Inspection Service (FSIS) Chief, Dr. Elisabeth Hagen stated to the New York Times, "If E. coli O157:H7 is an adulterant because it can kill your child, then other non-O157 STECs (like O26, O45, O103, O111, O121, and O145) that cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year, should be adulterants as well."

The MIT 1000 has the capability to identify bacterial strains and plans have been initiated to add the non-O157 STEC's to its ID library in 2011. "MIT is poised to be an important contributor to reducing future food contamination events as witnessed by the numerous MIT 1000 inquiries from prospective customers following the recent egg recall due to Salmonella and the aforementioned beef recall," stated Michael Brennan, MIT's Chairman and Chief Executive Officer. Mr. Brennan further stated, "The MIT 1000 System's ability to conduct an ID test in under 5 minutes for less than 10 cents classifies it as both a rapid and economical ID test that may enable food processors to confirm a food contamination event before widespread distribution has occurred." MIT plans to host a webinar later this month to provide a more detailed update of the Company's status, system and plans.

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Breakthrough Method Cuts E.coli Detection Time in Ground Beef

An innovative technique that employs a unique combination of already established instrumentation can significantly reduce the time taken to detect E.coli 0157:H7 in ground beef, said a new study. The US group, lead by Lisa Mauer, said the method uses infrared spectroscopy to cut the time to identify E.coli to just hours instead of days as with current testing methods. The associate professor of food science from Purdue University, told FoodProductionDaily.com the breakthrough technique had the potential to become an industry standard and her team was already working on adapting it to detect other pathogens such as Salmonella. sing Fourier transform infrared spectroscopy FT-IR, Mauer said E.coli had been detected in ground beef in one hour compared to the 48 hours needed by conventional plating technology carried out in laboratories. She added the same labs could use the compact spectroscopy equipment to get results in a fraction of this time. The technique is also able to differentiate between strains of E. coli 0157:H7, meaning outbreaks could be tracked more effectively and quickly. Current tests are multi-step and take almost one week to get results.

"Even with all the other bacteria present in ground beef, we could still detect E. coli and recognize different strains," said Mauer. The study – Detection of E.coli 0157:H7 from Ground Beef Using Fourier Transform Infrared Spectroscopy and Chemometrics – was published in the Journal of Food Science. The research showed two methods for separating bacteria from ground beef for testing. An antibody-capture method, which binds bacteria to antibodies attached to magnetic beads, gave results in four hours, while a filtration method achieved results in about an hour. Infrared spectroscopy could detect just one E. coli cell if the bacteria were cultured for six hours. Conventional plating techniques used for E. coli detection require culturing cells for 48 hours. The faster feedback is achieved as the FT-IR is able to read the E.coli’s specific infrared spectrum by interpreting the combination of energy that has been absorbed and energy that has been reflected back when infrared light is scanned over a sample. The testing methods can also distinguish between living and dead E. coli cells, something current testing methods cannot. While dead cells are not harmful, their presence could indicate something about the quality of the product, said the study.

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Rapid Micro Biosystems Awarded Contract by Biomedical Advanced Research and Development Authority (BARDA) to Develop Rapid Sterility Testing Platform for Vaccines

Rapid Micro Biosystems announced that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of rapid sterility testing for vaccines as part of the Innovative Platform Technologies program of BARDA’s Strategic Science and Technology Division. Under the terms of the agreement, Rapid Micro Biosystems will receive $2.2 million in the first contract year and up to an additional $4.5 million in two option years, for a total contract value of $6.7 million.

"We are pleased to be awarded this contract by BARDA," said Steve Delity, Chief Executive Officer of Rapid Micro Biosystems. "Rapid Micro is the leader in automated rapid detection, and we look forward to working closely with BARDA to develop a solution to help with pandemic response." Reducing the time-to-release of vaccines or other biopharmaceutical countermeasures will facilitate prevention and control of epidemic diseases like influenza, other emerging infections and agents of bioterrorism. Faster microbiological quality control (QC) testing will reduce the release cycle of vaccines by as much as two to four weeks. This time decrease will save countless lives by accelerating the release of safe product to the public in the event of a pandemic or bioterrorism attack.

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Rapid Micro Biosystems Names Julie Sperry to Post of Chief Commercial Officer

Rapid Micro Biosystems, a leading provider of non-destructive, rapid microbial detection, today named Julie Sperry Chief Commercial Officer. Sperry will lead the sales and business development efforts for the company’s Growth Direct™ system. She will report directly to the CEO, Steve Delity. Sperry brings more than 30 years experience in healthcare, pharmaceutical and manufacturing operations. Sperry previously served in various general management, sales and marketing leadership roles for a number of companies in the pharmaceutical research, development and production markets. Prior to her role as Chief Commercial Officer for Rapid Micro Biosystems, Sperry was with Thermo Fisher Scientific serving in several roles including; Vice President of Corporate Marketing, Vice President of Strategic Marketing for the Laboratory Products Group and Vice President of Global Sales and Marketing for the Lab Equipment Division. Sperry has also held global sales, marketing and general management roles with Millipore Corporation, Sartorius and the former American Hospital Supply.

Sperry graduated from Bowling Green State University in Bowling Green, OH with a B.S. degree in Chemistry and Microbiology and with an MBA from Rockhurst College in Kansas City, MO. “Julie Sperry is the perfect choice for Chief Commercial Officer at Rapid Micro Biosystems. She brings significant knowledge of the pharmaceutical manufacturing industry and a proven ability to drive business growth,” ‘said CEO, Steve Delity “We are grateful to have her aboard and believe our customers and partners will be excited by her vision and proven track record of success. Sperry commented: “I am honored to have the opportunity to join Rapid Micro Biosystems at a time of accelerated growth. With our unique value proposition to the Micro QC lab, I am confident we can continue to help companies in the pharmaceutical industry save time and money, while improving their productivity.”

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Bruker Introduces the MALDI Sepsityper™ Kit for Rapid MALDI Biotyper Microbial Identification from Positive Blood Cultures

At the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Bruker Daltonics Inc. announced the introduction of the new MALDI Sepsityper(TM) kit for the rapid identification of microorganisms from positive blood culture bottles, using Bruker's industry-leading MALDI Biotyper solution. The MALDI Biotyper has obtained the IVD-CE Mark, and is currently for Research Use Only (RUO) outside of the European Union.

The MALDI Sepsityper kit is a set of consumables that enables a rapid and easy identification workflow after the blood culture bottle has tested positive. Microbial cells are harvested from an aliquot of blood culture, are processed using the MALDI Sepsityper kit, and are then identified by the MALDI Biotyper workflow. The identification assay from positive blood cultures is applicable to gram-negative bacteria, gram-positive bacteria, and importantly also to yeasts. Only a few minutes after taking an aliquot from the blood culture bottle, a sample can be ready for mass spectrometry-based molecular identification by the MALDI Biotyper. This workflow is recommended and optimized for blood culture bottles without any charcoal supplements, because such supplements would need to be removed first by additional sample preparation steps.

By using the new MALDI Sepsityper product in combination with the MALDI Biotyper, in approximately 70-90% of the tested positive blood culture samples, a high-confidence identification result is available much earlier than with conventional technology, typically saving one day (or more) in time-to-result (TTR) for the crucial identification step. The MALDI Sepsityper kit and MALDI Biotyper identification rapid blood-culture-to-ID workflow did not lead to any false positives during initial testing and validation. Bruker is planning further MALDI Sepsityper kit validation studies with an expanded number of European clinical microbiology laboratories processing blood culture samples.

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Identification of Clinically Significant Microorganisms

Thermo Fisher Scientific has announced that its range of biochemical identification kits is one of the widest available to clinical microbiologists today, providing reliable results in simple and convenient formats. The range, which includes the rapid and easy-to-use Remel RapID microbial identification systems and the Oxoid Microbact biochemical identification kits, requires no capital investment, so it allows even small laboratories to confirm the identification of clinically significant bacteria, yeasts and fungi. The RapID range is the fastest and most convenient identification system of its kind. With its simple, one-step inoculation procedure, it allows accurate identification of a comprehensive range of micro-organisms in just four hours. The RapID method detects pre-formed bacterial enzymes and, therefore, is not dependent on the growth of the organism. This allows the panels to be incubated aerobically without the need for oil overlays, which saves time and resources.

Each RapID kit has the same simple procedure, allowing it to be adopted easily in laboratory workflows, and the biochemical reactions are clearly visible as distinct color changes. These are interpreted quickly and conveniently by the Electronic RapID Compendium (ERIC), a user-friendly, Windows-based software package, to minimize misidentifications and to ensure accurate and reliable results. In trials, RapID kits demonstrated excellent performance in the identification of oxidase negative Enterobacteriaceae, anaerobic bacteria, Gram-negative glucose non-fermenters, Corynebacterium species, yeasts and related organisms and streptococci and related organisms. In addition, a new system for the identification of staphylococci and related organisms is now available. The Oxoid range of Manual Identification Systems also includes the Microbact biochemical identification kits for the identification of Gram-negative bacteria (the Enterobacteriaceae and miscellaneous Gram-negative bacteria) (Microbact 12A/E; 12B and 24E), Listeria species (Microbact 12L) and clinically important staphylococci (both coagulase-negative and coagulase-positive staphylococci) (Microbact 12S). These kits are available in convenient strip or microplate format, and organism identifications are based on pH changes and substrate utilization.

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Celsis Rapid Detection at the 2010 International Dairy Show

Celsis Rapid Detection will introduce several advances in rapid microbial detection for the dairy industry at its booth, #432, during the 2010 International Dairy Show, September 13-15 in Dallas, TX. Dairy manufacturers around the world already enjoy significant savings of time and money with Celsis Rapid Detection—including an average 5-year net present value of $500,000 or more—by shortening their product testing times from 4-7 days to only 24-48 hours allowing for reduced inventories and faster response to contamination when it occurs. The new features and options added to the Celsis Innovate system help manufacturers and packagers operate more efficiently and improve regulatory compliance. Celsis Innovate systems are used to rapidly and effectively screen a growing variety of UHT, aseptic and ESL dairy, food and beverage products, including syrups, soups and broths, brewed tea, sports and nutritional drinks, pudding, infant formula, condiments and sauces, nut milks and fruit and vegetable juices.

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ARUP Laboratories Selects Bruker's MALDI Biotyper Solution for Rapid Microbial Identification by Proteomic Fingerprinting

Bruker Daltonics today announced that ARUP Laboratories (a reference laboratory owned by the University of Utah) has selected and installed the Bruker MALDI Biotyper system as their next-generation rapid microbial identification system. The MALDI Biotyper has obtained the IVD-CE Mark, and is currently for Research Use Only (RUO) outside of the European Union. The MALDI Biotyper is a MALDI-TOF mass spectrometry based platform for rapidly identifying bacteria, yeasts and fungi. Its carefully curated database includes quality-controlled entries of over 3,700 strains from about 2,000 well-characterized microbial species.

Starting from a cultured colony, identification is performed by matching the measured protein fingerprint against the proprietary MALDI Biotyper database. Including the database search, automatic identification can be performed in minutes. Multiple colonies can be spotted on a single target, and about 30-60 identifications can be performed every hour. The MALDI Biotyper offers rapid time-to-result, high specificity, very low false positive rates, low operational costs, and low technical barriers for new operators. Bruker has installed over 150 MALDI Biotyper systems worldwide in routine laboratories for microbiology, and the MALDI Biotyper is rapidly becoming a new standard for robust, rapid microbial identification. ARUP plans to use the MALDI Biotyper for microbial identifications currently performed by DNA sequencing, and expects to see improvements in time to result, workflow and consumables costs. ARUP is also investigating the use of the MALDI Biotyper to replace phenotypic methods for identification, and plans to collaborate with Bruker to develop additional tests on the MALDI Biotyper.

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Microbiology Market Review 3rd Edition

Research and Markets has announced the addition of the "Industrial Microbiology Market Review 3rd Edition" report (IMMR-3). The Industrial Market is second only to the Human Clinical Market as a sizable and growing opportunity for microbiological testing. IMMR-3 is an extensively-researched overview of testing and trends worldwide, focused on the food, beverage, environmental, pharmaceutical, personal care product, and industrial process sectors. Testing volume is analyzed by type of organism, sample source, geography, and market sector. Current market values are established and projected. Complementing the analysis are detailed company profiles of 25 key test manufacturers serving the industrial diagnostics market. In addition, IMMR-3 also provides Special Situation assessments of two important market opportunities for diagnostic companies: Bioterrorism and Healthcare Infection Control. These new segments are both timely and could represent significant testing potential.

Rapid testing methods are growing at twice the rate of market growth and gaining important market share in the Industrial Market. With five-year projections of both testing volumes and market value, IMMR-3 provides critical input to strategic planning. IMMR-3 is 220 pages in length with 250 data tables, charts, and exhibits. Key topics covered include: Industrial Microbiology Market Summary; Scope; Definitions, and Methodology; Market Trends; Food Sector; Beverage Sector; Pharmaceutical Sector; Personal Care Products Sector; Environmental Sector; Industrial Process Sector; Bioterrorism; Healthcare Infection Control; 2013 Forecast Detailed Review; Rapid Microbiology Potential; Competition Business Review/Summary and Competitor Profiles. Twenty five companies are mentioned in the report.

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U.S. Department of Agriculture and DuPont Collaborate on New Test for Hard to Detect Foodborne Pathogens

DuPont and the U.S. Department of Agriculture have agreed to collaborate on the development of a new test for detecting hard-to-identify strains of toxin-producing E. coli that are not currently regulated and have been causing increased instances of food contamination and illness. The U.S. Centers for Disease Control estimate that non-O157 STEC bacteria are responsible for 36,000 illnesses, 1,000 hospitalizations and 30 deaths annually. DuPont was among the first to develop tests for E. coli O157:H7, the type of shiga toxin-producing E. coli (STEC) most frequently associated with global food contamination outbreaks.

The USDA Food Safety and Inspection Service uses the DuPont™ BAX® System to monitor for this pathogen. In recent years, other types of STEC have been identified as agents of foodborne illness, and these are a growing concern in the United States, Europe, Japan and food safety agencies worldwide. The Agriculture Research Service of the U.S. Department of Agriculture (USDA ARS) will collaborate with DuPont Qualicon to develop an effective test for the “Big 6” non-O157 STEC pathogens in food, and also will expand the diagnostic tools offered for use in the DuPont™ BAX® System. Food processing companies around the world rely on the BAX® System to detect pathogens or other organisms in raw ingredients, finished products and environmental samples.

The automated system uses leading-edge technology, including polymerase chain reaction (PCR) assays, tableted reagents and optimized media to detect Salmonella, Listeria species, Listeria monocytogenes, E. coli O157:H7, Enterobacter sakazakii, Campylobacter, Staphylococcus aureus, Vibrio, and yeast and mold.

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BIOTECON Diagnostics receives MicroVal approval for the foodproof® Enterobacteriaceae plus E. sakazakii (Cronobacter spp.) Detection Kit

BIOTECON Diagnostics has received a new approval from MicroVal for the foodproof® Enterobacteriaceae plus E. sakazakii (Cronobacter spp.) Detection Kit. The foodproof® RoboPrep+ Series is the first commercially available system for automated food sample preparation and subsequent PCR setup. It has been developed as a cost-effective tool for food pathogen testing, drastically reducing hands-on time and increasing lab efficiency. The largest platform, the foodproof® RoboPrep+ 150-8, allows the simultaneous preparation of 96 samples in just 2 hours and 20 minutes (2 hours 40 minutes including PCR setup). No manual handling steps are necessary other than the loading of samples and consumables. Automated sample preparation is performed using the foodproof® Magnetic Preparation Kit I. The kit's magnetic bead technology isolates highly purified DNA from liquid sample enrichments, while minimizing inhibiting matrix influences. BIOTECON Diagnostics also offers the AOAC and NordVal validated Salmonella Detection Kit. The kit detects down to 1-10 cells per 25 g sample and provides an unmatched inclusivity, showing no false-negative results when tested with more than 700 different Salmonella strains. Other platforms include kits for the detection of Brucella, Campylobacter, E. coli, Shigella and Listeria.

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BD Announces First FDA-Cleared Assay on the BD MAX™ System to Detect Group B Streptococcus

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the BD MAX™ GBS Assay for Group B Streptococcus (GBS) on the BD MAX™ System. The BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility. GBS remains one of the leading causes of morbidity and mortality among newborns, with maternal colonization serving as a major risk factor for early onset GBS disease. However, it is preventable with antibiotics during labor, which prevents transmission from mother to infant.

The U.S. Centers for Disease Control and Prevention (CDC) recommends universal prenatal screening for GBS colonization and intrapartum chemoprophylaxis for colonized mothers in order to prevent transmission to infants. The current standard of care for preventing neonatal GBS disease is screening pregnant women at 35 to 37 weeks of gestation using culture methods, which are limited by sensitivity, turnaround time and the need for highly trained technologists to interpret the results. “The BD MAX GBS assay on the BD MAX System is the only fully automated polymerase chain reaction method for the detection of GBS from vaginal/rectal swabs after Lim broth selective enrichment,” said Dr. Steve Young, TriCore Reference Laboratories, a clinical trial site. “As new CDC guidelines emerge to include molecular testing as an alternative to culture for detecting GBS, the BD MAX GBS assay could serve as an efficient, sensitive and specific option for laboratories desiring to utilize a molecular method.”

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AdvanDx Launches GNR Traffic Light™ PNA FISH® in Europe

AdvanDx announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe. GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying (i)Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes. Every year, close to 875,000 patients in the United States contract bloodstream infections, leading to over 150,000 deaths and $12 billion in patient care costs. The infection is detected when a culture of the patient’s blood (i.e. a blood culture) turns positive with bacteria or yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don’t require the extensive sample preparation necessary for other nucleic acid technologies. PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.

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Life Technologies Announces Agreement to Acquire Ion Torrent

Life Technologies recently announced an agreement to acquire Ion Torrent. Ion Torrent has revolutionized DNA sequencing by enabling a direct connection between chemical and digital information through the use of proven semiconductor technology. Ion Torrent's proprietary chip-based sequencing represents a new paradigm in DNA sequencing by using PostLight™ sequencing technology, the first of its kind to eliminate the cost and complexity associated with the extended optical detection currently used in all other sequencing platforms. The first product using this technology will be the Personal Genome Machine (PGM), an easy-to-use, highly-accurate benchtop instrument optimal for mid-scale sequencing projects, such as targeted and microbial sequencing. The instrument is currently available through an early access program and will be launched later this year. Subsequent products will benefit from cutting edge semiconductor fabrication technologies that can expand throughput at an accelerated pace, thereby dramatically lowering the cost to sequence a genome.

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Seegene Announces Multiplex Real-Time Detection System

Seegene announced SeePrep™ and SeeCycler™, new clinical instrumentation optimized for Seegene's multiplex real-time detection tests. SeePrep performs automated magnetic bead nucleic acid extraction, and SeeCycler is an automated detection system for processing samples in real-time. With the addition of these equipment Seegene is now able to provide a complete molecular diagnostic workflow optimized for its multiplex tests, including nucleic acid extraction, amplification, real-time PCR testing and data analysis. Seegene is also pioneering a new category of multiplex PCR technology that enables the simultaneous detection of viruses and bacteria in a single reaction.

Seegene's innovative real-time PCR method, READ™ (REal Amplicon Detection), is a powerful technology that overcomes the limitations of conventional real-time PCR. READ™ is totally different from current probe- (TaqMan, Molecular Beacon, etc.) and primer-based (Scorpion, LUX, Sunrise, etc.) real-time PCR methods, and opens new opportunities for highly effective pathogen detection. The Magicplex™ System is a two step process system based on READ™ technology that amplifies multiple target genes and then selectively detects the amplicons on a real-time PCR platform. The system provides maximum sensitivity and specificity by detecting the amplicons produced by the first amplification step. This unique process overcomes the limitations of conventional PCR and real-time PCR testing methods, such as low specificity and sensitivity, limited multiplexity, high re-test rates, long processing cycles and narrow range of applicable specimens for testing.

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qPCR Used to Develop Rapid Response Strategies for Contaminated Beaches

The Southern California Coastal Water Research Project (SCCWRP) has been working with academic and industry researchers since the late 1990s to evaluate and refine rapid microbiological methods for beach water quality analysis. Application of rapid methods would improve public health protection by providing more accurate and timely information on which to base beach warning and closure decisions. Implementation of rapid methods has also been mandated by the Federal BEACH Act and California AB 639. Currently, research shows that quantitative polymerase chain reaction (QPCR) is the most viable rapid method for application to beach monitoring.

In order to advance the application of rapid methods, the SCCWRP Commission created a Rapid Methods Task Force in 2009, consisting of experts representing multiple stakeholders. After reviewing the available science, the Task Force initiated a pilot project in summer 2010 that will explore the efficacy of using rapid methods for issuing beach warnings and closures in southern California. The goal of this project is to assist the Task Force by conducting training and outreach to enable a pilot project where QPCR is used in parallel with traditional methods for monitoring at selected southern California beaches. The objective is to produce rapid test results that can be utilized for making beach warning decisions and posting signs (if necessary) on the same day a sample is taken.

A rapid method dry-run in which methods are transferred to local laboratories was implemented in May and June, which will be followed by a demonstration project in July and August (if warranted). Throughout the pilot, all samples will be processed by both rapid and traditional methods. The Task Force’s chosen method is QPCR with Scorpion primers and probes, using a BioRad thermocycler and no DNA purification step.

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Life Technologies Sets New Workflow Standard in Detection of Common Contaminants in Biopharmaceutical Manufacturing

Life Technologies Corporation announced a program that streamlines the detection of three common contaminants of mammalian cell culture-based biopharmaceutical manufacturing. The Applied Biosystems Cell Culture Rapid Methods Program applies core technologies from across the company to combine one sample preparation step with one instrument platform for real-time PCR based detection of Mycoplasma, Vesivirus 2117 and Mouse Minute Virus (MMV). Mycoplasma, Vesivirus 2117 and MMV are DNA and RNA-based potential contamination threats in mammalian cell culture production.

Because of its high accuracy and rapid same-day results, the Cell Culture Rapid Methods Program helps enable in-process testing for these contaminants at multiple points along the biopharmaceutical manufacturing process. These biologic detection kits are highly sensitive and accurate tests that enable the quick isolation and detection of these known contaminants from cell culture samples. The improved protocol for PrepSEQ™ 1-2-3 Nucleic Acid Extraction Kit can extract nucleic acid for all three contaminants from a single cell culture, in order to speed the detection of a multiple number of organisms. Sample preparation and detection of all three contaminants can be performed in less than seven hours. It is expected that biopharmaceutical companies will use the program to detect potential contamination early in production, safeguarding the manufacturing processes.

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ZyGEM Introduces Microbial Fingerprinting Diagnostic Technology

ZyGEM Corp. Ltd., has introduced its new microbial fingerprinting diagnostic technology that is expected to dramatically reduce the complexity and time needed to identify unknown infectious agents in mixed population samples. The approach is designed to run on the company’s new MicroLab platform and has the potential to accurately identify up to 30 types of microbes simultaneously from a single sample in less than an hour. The ZyGEM system combines ZyGEM’s proprietary DNA extraction and microbial detection technologies with PCR amplification in a single automated reaction that occurs in its integrated ZyGEM/MicroLab microfluidic device. This device miniaturizes the entire DNA testing process within a single closed system, which significantly reduces the amount of sample and reagents needed while virtually eliminating the chance for handling error or contamination. ZyGEM researchers have developed a catalog of “fingerprints,” or DNA markers, for a broad range of microorganisms. Special software developed for the system uses these fingerprints to identify and discriminate between the microorganisms in mixed microbial populations.

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French Committee for Accreditation (Cofrac) Authorizes the Use of Kits for Water Microbiological Analysis When Certified Under the AFNOR VALIDATION Scheme

Cofrac was requested to recognize the rapid analytical methods that were validated under the AFNOR VALIDATION scheme in the field of water microbiological analysis. These methods are mainly used in the area of auto-control for the following types of water: process water (production of water for human consumption), bathing water, thermal water and cooling towers. Based upon a presentation of the AFNOR VALIDATION Scheme as well as a description of the Technical Board for water microbiology (nomination of members, principles of certification, validation protocols …) and following exchanges with several technical assessors in this field, the members of the Technical Accreditation Commission “Chemistry and Environment” decided to approve this accreditation.

Consequently the Technical Accreditation Commission “Chemistry and Environment” authorizes accreditation of laboratories using AFNOR validated kits on condition that (i) validation has been conducted by comparing the kit with a standardized reference method; (ii) the laboratory using the kit has been accredited upon the reference method (or required simultaneously an extension of accreditation for the reference method); and (iii) the technical protocol of the kit enters the area of competence of the technical assessor. Assessors in water microbiology could be mandated in order to assess this activity. The laboratory assessment should be done according to the requirements stated in EN ISO/CEI 17025 standard (and its application document LAB REF 02) paying a particular attention to the capacitation of the staff, to the management of the equipment and to the of the quality insurance of the results.

Remark : the case of PCR kits for the detection/enumeration of Legionella is apart as it does not deal with validation in comparison to a reference analytical method. When these PCR kits are certified under the AFNOR VALIDATION scheme, Cofrac takes into account the contents of their validation file (recovery , linearity, specificity,…).

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Advanced Analytical Opens Sales Office and Laboratory in Heidelberg, Germany

Advanced Analytical has opened a new sales office and laboratory in Heidelberg Germany. The new facility is located in the Technologiepark on the campus of the Heidelberg University. By opening this office, the company will be able to provide better representation over sales for their suite of products sold as well as provide better support and service for their current and future customer base. The office in Heidelberg will serve as both the European headquarters for the company and as a Center of Excellence. Furnished with analytical instruments, AATI will be able to serve the growing European pharmaceutical/biopharmaceutical industry as well as the biotechnology and university research communities. The company’s product portfolio includes instruments for the rapid detection and enumeration of microbes by flow cytometry, and the parallel analysis of pharmaceutical compounds, biomolecules, proteins, DNA, RNA by capillary electrophoresis with UV absorbance or fluorescence detection.

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Millipore Launches the New MilliPROBE® Detection System for Mycoplasma

Millipore Corporation
290 Concord Road
Billerica, Massachusetts 01821
phone: +1 978-715-4321
website: www.millipore.com/milliprobe

Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, announced the launch of a new product from its ground-breaking collaboration with Roka Bioscience to develop faster, more robust tests for contaminants in pharmaceutical and biotechnology manufacturing. The MilliPROBE® Detection System for Mycoplasma is the first solution of its kind for the early detection of Mycoplasma contamination in the highly regulated biopharmaceutical manufacturing industry.

"The launch of our new MilliPROBE System represents a breakthrough innovation and is the culmination of four years of collaborative work to change the way the industry tests for Mycoplasma," said Jean-Paul Mangeolle, President of Millipore's Bioprocess Division. "The system builds on Millipore’s strength in mycoplasma risk management. It integrates our industry-leading sample preparation technologies and testing expertise with core molecular diagnostics technologies developed by Gen-Probe, Incorporated (and recently licensed to Roka Bioscience), to deliver a unique solution that addresses an immediate and critical market need. We are extremely excited about the market opportunity for the MilliPROBE System."

Mycoplasma is a small, slow-growing and self-replicating bacteria that is extremely difficult to detect and eliminate from biopharmaceutical manufacturing processes. Mycoplasma contamination can have costly consequences for biopharmaceutical manufacturers, who must often destroy an entire drug batch and shut down production facilities for an extended period when Mycoplasma contamination is detected.

The MilliPROBE Detection System for Mycoplasma, the newest assay in Millipore’s MilliPROBE platform aimed at rapid microbial detection, cuts detection time from between 28 and 35 days (for traditional culture-based technology) to just four hours. Faster and more robust detection enables biopharmaceutical manufacturers to test more frequently and take corrective action earlier in the production process, reducing financial risks and optimizing product yields.

"The MilliPROBE system is unique because it can be operated by technicians with limited molecular training, while meeting the stringent requirements of the biopharmaceutical quality control lab," noted Roland Heinrich, Millipore Vice President, Process Monitoring. "It includes a novel Millipore sample preparation device designed to handle complex bioreactor samples in larger volumes than other mycoplasma testing products. It also includes Gen-Probe’s new Background Reduction Technology (the first of its kind), which protects the assay from contamination that can cause false positive results - a prevalent testing problem representing substantial financial risk for customers."

"We will continue to leverage our ongoing partnership with Roka Biosciences to introduce additional MilliPROBE assays in the future," Heinrich added.

In 2005, Millipore and Gen-Probe, based in San Diego, California, formed an exclusive partnership to develop faster, more reliable and sensitive tests for contaminants commonly found in pharmaceutical and biotechnology manufacturing processes. In September, 2009, Millipore transferred its collaboration to Roka Bioscience, an independent company created through the spin-off of Gen-Probe’s industrial assets.

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Millipore Launches the New Milliflex® Quantum Rapid Microbial Detection System

Millipore Corporation
290 Concord Road
Billerica, Massachusetts 01821
phone: +1 978-715-4321
website: www.millipore.com/milliflexquantum

Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, announced the launch of its new Milliflex® Quantum rapid microbial detection system. The system enables drug and vaccine manufacturers to respond to microorganism contamination earlier in the production process.

"The Milliflex Quantum system provides results faster than traditional testing methods. It is designed to significantly improve product quality management, helping customers to release product to the market sooner and avoid line shutdowns," said Roland Heinrich, Ph.D., Vice President for Process Monitoring in Millipore’s Bioprocess Division.

"The system is based on two widely adopted technologies – membrane filtration, performed with proven Milliflex membrane filtration devices, and fluorescent staining – to ensure consistent, reliable results," Heinrich continued. "In addition, the validation process is streamlined because it involves only minimal changes to the compendial tests currently used."

The Milliflex Quantum system is ideal for testing raw material, in-process samples, final product and environmental samples. It is non-destructive, an important feature that enables operators to grow microorganisms in order to identify them with standard ID technology. The majority of rapid test systems are destructive in nature, which means they offer limited capabilities for microorganism investigation and identification.

The Milliflex Quantum system consists of a reader, camera and fluorescent reagents used in combination with the Milliflex PLUS pump, Milliflex filtration devices and media cassettes. It is compact and easy to learn, for smooth integration into an existing laboratory set-up. Millipore offers a comprehensive range of services to support the system’s implementation, including installation, operational and performance qualification guidelines.

"This innovative new system extends Millipore's rapid microbial detection portfolio, which includes the recently launched MilliPROBE® detection system for mycoplasma," Heinrich noted. "The simple two- to three-step method ensures accurate microbiological results, while reducing overall time to result."

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InDevR Announces the Availability of Their Virus Counter for Rapid Virus Quantification

InDevR (Boulder, Colorado) announced the availability of the Virus Counter for rapid virus quantification. The Virus Counter is a unique bio-analytical tool that enables scientists to measure virus particle concentration within minutes. Unlike conventional plaque titer assays, which take days to complete, the Virus Counter provides accurate virus quantification in less than 10 minutes. The unprecedented efficiency and accuracy of virus quantification with the Virus Counter is anticipated to dramatically accelerate vaccine and antiviral therapeutic research and development. The Virus Counter represents the next generation of compact “personal” flow cytometers designed for a specific application. The Virus Counter works for both RNA and DNA viruses and researchers will find that the instrument assay is fast, cost-effective, and easy to use. For purified viruses, the assay involves a simple staining step followed by a 5- to 10-minute analysis on the Virus Counter. Virus Counter InCyt software is intuitive and features real-time data analysis that further reduces the time-to-results.

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Micro Identification Technologies and OSI to Manufacture the MIT 1000 Light Scattering Microbial Identification System

Micro Identification Technologies, Inc. (MIT) announced that it has signed an Agreement with OSI Optoelectronics (OSIO), a subsidiary of OSI Systems to manufacture its microbial rapid identification system, the MIT 1000. The MIT 1000 is a laser-based, microbial rapid identification system capable of identifying 23 different species of pathogenic bacteria just minutes after culturing. Due to the small sample volume required, culture time is also reduced by up to 50% compared to standard testing procedures. In most cases, results can be obtained in as little as eight hours from the time the culturing process begins. The device uses the principles of light scattering to discriminate various bacteria cells that are suspended in filtered water. Incident laser light both reflects off the bacteria’s outer surface and penetrates the body of the bacterium, the light interacts with any structural features and eventually emerges from inside the cell. These light patterns are unique for each species and thereby create a signature that is captured and stored in a computer data base. The MIT 1000 features 35 photo detectors that surround the sample vial and collect light scattering intensities that are generated when a cell intersects the laser beam. Identification occurs when 10-50 organisms are analyzed, and typically takes less than 10 minutes.

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Shimadzu and bioMérieux to Develop Mass Spectrometry System for Microbial Identification

Shimadzu and bioMérieux announced that they have entered into a partnership to commercialize a mass spectrometry system for bacterial identification. bioMérieux will work with Shimadzu and their subsidiary, Kratos Analytical, to adapt their linear MALDI-TOF mass spectrometry technology for optimized integration into the microbiology laboratory workflow. This new solution is planned for commercialization by bioMérieux in 2010, together with the microbial database acquired from AnagnosTec.

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Rapid Micro Biosystems Releases Service Pack 2 Software for Growth Direct™

Rapid Micro Biosystems announced the availability of Service Pack 2 software for the Growth Direct™ System. The new release includes both user and industry driven product features that enable Quality Control labs to improve their performance by optimizing workflow and eliminating waste. These capabilities will drive the transformation from manual quality control to an automated, paperless laboratory. New alerting features let the business respond faster to key quality events, such as the early warning of contaminated product samples, improving efficiency, speeding corrective actions and preventing product loss. The paperless QC lab is enabled through seamless LIMS connectivity that automates results recording, data management and reporting, a common source of errors. The system automatically archives results and history, integral to regulatory compliance and critical for traceability and audit-ability. Additionally, custom reporting allows users to tailor reports specific to their laboratory and business needs.

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