Tuesday, December 27, 2011

Meridian Bioscience Receives FDA Clearance For ImmunoCard® C. difficile GDH Test

Meridian Bioscience, Inc. today announced it has received FDA clearance for a new Clostridium difficile assay, ImmunoCard® C. difficile GDH. This test detects the C. difficile common antigen glutamate dehydrogenase (or GDH). This assay has already been successfully launched and accepted in global markets as an excellent screening option for C. difficile. The GDH common antigen is present in both toxigenic and nontoxigenic strains of C. difficile.

Toxigenic strains of C. difficile are frequently associated with hospital and community-acquired diarrhea and can lead to life-threatening complications or death. Therefore, laboratories can use this highly sensitive screening test to identify patients with a suspected C. difficile infection and then reflex positives to a sensitive and more specific molecular assay like illumigene(R) C. difficile, which can confirm infection with the toxin-producing strains. Meridian Bioscience is the only manufacturer that can provide a complete portfolio of C. difficile testing solutions that meets the needs of its global customers. ImmunoCard C. difficile GDH, used in conjunction with illumigeneC. difficile, empowers cost-sensitive laboratories with an economical algorithmic option for C. difficile diagnostic testing.

Jack Kraeutler, Chief Executive Officer stated, "C. difficile continues to be both a dangerous and costly infection for patients and the healthcare institutions that care for them. For a screening test to be most effective, it must be very sensitive so as not to miss any true positives. In rigorous clinical studies, ImmunoCard C. difficile had the highest negative predictive value when compared against competing screening tests. The introduction of ImmunoCardC. difficile GDH in the US market continues Meridian's legacy of leadership in the detection and identification of C. difficile. This new product, along with the Meridian illumigeneC. difficile molecular assay, allows laboratories to identify C. difficile infected patients with a rapid screening test and molecular confirmation in less than two hours."

Researchers Strike Gold with Nanoparticle Virus Test

An Egyptian research team has won a prize for developing a hepatitis C test using gold nanoparticles. The test could become a cheap and rapid way to screen people and blood banks for the virus. Hassan Azzazy, chair of the chemistry department at The American University in Cairo (AUC), and his team, won third place at the Intel Global Challenge held at the University of California, Berkeley, in the United States, last month (7–10 November) winning US$10,000.

"Nanoparticles are promising tools for developing the next generation of diagnostic assays because of their unique properties," Azzazy told SciDev.Net. He said gold nanoparticles exhibit a phenomenon known as surface plasmon resonance, which causes them to change colour from an intense red to blue when they aggregate. The test works by adding a target agent that binds to viral genetic material, forcing the nanoparticles to aggregate and turning the solution blue.

Azzazy said that "conventional detection of active hepatitis C generally requires two tests that take from three to four days and cost about US$78 per sample, while the nanogold test can generate similar results in less than one hour and for one-tenth of the cost. One gram of gold tetrachloride costs US$260 and is enough for 10,000 samples."

According to the WHO, hepatitis C infects 200 million people worldwide, but is especially prevalent in the Middle East and North Africa (MENA) with about 9.2 million individuals infected. For most MENA countries, the prevalence is between one and two per cent; the exception is Egypt where estimated prevalence is 14 per cent for adults aged 15–60.

"Early identification and treatment of infected patients is critical to reducing transmission of the disease, and a fast and relatively cheap new assay will be of great help," said Hala Gabr, professor of haematology at Cairo University.

Amr Abul-Fotouh, lecturer in tropical medicine and hepatology at Cairo University, added: "Although the nanogold test is a good one, it is not quantitative so it cannot be used to treat and follow up patients, as this needs the quantity of the virus to be detected by a PCR [polymerase chain reaction] test".

He pointed out that the new assay could be used in blood banks to check for hepatitis C. "We have seen that about 20 per cent of Egyptian blood donors test positive for the virus," he said.

Sherif Shawky, a doctoral fellow at AUC, and a member of the research team, told SciDev.Net that the technology can be adapted for detecting other infectious agents such as tuberculosis, and for use as cancer biomarkers. A spin-off company, NanoDiagX, has been set up to develop these bio-nanotechnology platforms.

Nanosphere Receives FDA Clearance of Gram-Positive Blood Culture Test for Staphylococcus

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has received 510(k) clearance from the FDA for the Verigene(R) Staphylococcus Blood Culture Nucleic Acid Test (BC-S). The BC-S test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections.

The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene BC-GP test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is currently under FDA review.* Last week, Nanosphere obtained CE-IVD Mark for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe.

"With the BC-S test, clinicians diagnosing patients suspected of deadly infections have a rapid, accurate molecular diagnostic tool which can differentiate two important disease-causing Staphylococcus bacteria, while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment decisions," said Nanosphere CEO Bill Moffitt. "With this clearance we continue expansion of our product offering, enabling microbiologists to replace century-old methods with rapid, accurate molecular diagnostic tests," he added

In a single automated test, the Verigene BC-S test provides detection of Staphylococcus aureus, Staphylococcus epidermidis, and the mecA gene. The mecA gene confers resistance to the antibiotic methicillin/oxacillin. Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia is associated with a significantly higher mortality rate than methicillin-susceptible Staphylococcus aureus bacteremia, posing a substantial healthcare burden.

The BC-S test provides species and resistance detection from two types of gram-positive blood culture bottles within two and a half hours, as compared with current microbiological culture methods, which can take up to 3 days. Identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment. Studies have shown that delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour that therapy is delayed. Rapid molecular testing of blood cultures has been shown to reduce this time, and is associated with hospital cost savings of up to $21,000 per patient.

The sample-to-result BC-S test automates the steps of bacterial nucleic acid extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-S test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.

Wednesday, December 21, 2011

Taiwanese Researchers find Way to Quickly Detect Bacteria in Blood

Taiwanese researchers have developed a bio-nanotechnology platform that makes it possible to rapidly capture and detect bacteria in human blood samples without the need for time-consuming culture processes.

"Detecting bacteria in clinical blood samples without using time-consuming culture processes will allow more rapid diagnoses," said Wang Yuh-lin, a distinguished research fellow at Academia Sinica and National Taiwan University (NTU) professor, who led the research team.

According to Wang, conventional methods commonly require a sample preparation time ranging from days for fast growing bacteria to weeks for slow growing bacteria.

The result was reported in the Nov. 15 issue of the journal Nature Communications.

Liu Ting-yu, an assistant professor at NTU and a member of the team, said that "like every instrument that has its own distinct sound, every molecule has its specific spectrum, and scientists have used the feature to differentiate bacteria."

He said that coating silver-nanoparticle arrays with the antibiotic vancomycin using a technology called surface-enhanced Raman spectroscopy (SERS) can lead to a 1,000-fold increase in bacteria capture compared with conventional approaches.

Vancomycin was chosen because it is one of the strongest antibiotics available and captures nearly all forms of bacteria.

Liu said the captured bacteria can then be concentrated in a special vancomycin coated module, while blood cells are excluded, making identification easier.

The development could have wide-ranging benefits, with the top priority at present the detection of sepsis, a potentially deadly condition that is characterized by a whole-body inflammatory state and the presence of known or suspected infection.

Doctor Han Yin-yi of NTU Hospital said the technology would help obtain a much faster and more precise initial test result of the infection, reducing patient fatalities and the incidence of complications.

Han said that once the technology becomes available, doctors will no longer have to engage in guesswork when prescribing drugs to patients, and antibiotic abuse will also be reduced.

Monday, December 19, 2011

Particle Measuring Systems Offers the The BioLaz™ Real-Time Microbial Monitor for the Rapid Detection of Airborne Organisms

Particle Measuring Systems
5475 Airport Blvd.
Boulder, Colorado 80301
phone: +[1] 303-443-7100
fax: +[1] 303-546-7380

Particle Measuring Systems Offers 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 provides immediate notification when biological particles are present and real-time verification of biological activity levels during aseptic manufacturing or other operations. This significantly improves the ability to demonstrate control over clean environments.

BioLaz Technology

The BioLaz uses a proven solid state laser-based optical technology for the detection of biological organisms. Air is drawn into the system and if biological particles are present, they fluoresce and are counted in real-time. The BioLaz Real-Time Microbial Monitor’s benefits include:
  • Validated to USP <1223> Validation of Alternative Microbiological Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality
  • Continuous monitoring with real-time reporting of biological counts
  • Easy to integrate data via RS-232 or Ethernet communications
  • Internal pump, eliminating the need for external vacuum systems
  • Small footprint, 316L stainless steel enclosure
Environmental Monitoring Integration

The BioLaz integrated with traditional methods, Agar plates and particle counters, can lead to improved compliance and potential cost reductions. Particle Measuring Systems provides turn-key systems with traditional particle and microbial monitoring, combined with rapid microbial detection into one complete environmental monitoring solution.

Please visit our web site at www.pmeasuring.com to view an introductory video detailing the BioLaz™ Real-Time Microbial Monitor’s operations and capabilities.

Particle Measuring Systems is the global leader in environmental monitoring technology, with 40 years of experience providing solutions for particle and microbial monitoring for companies with cleanroom manufacturing environments. As the inventor of laser-based particle counters, Particle Measuring Systems sets the standard for particle monitors in pharmaceutical, nanomaterial, aerospace, integrated circuit and electronics manufacturing.

New BD Veritor™ System for Rapid Detection of Flu A+B Receives 510(k) Clearance and CLIA Waiver

BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.

The BD Veritor System delivers very good analytical sensitivity and specificity, offering healthcare professionals a new and different option in rapid influenza testing versus current visually read CLIA-waived assays. The BD Veritor System provides objective results on an easy to read digital display, unlike current CLIA-waived rapid influenza tests, which require a subjective visual test interpretation to determine a positive or a negative test result.

"The new BD Veritor System provides a new approach for CLIA-waived rapid tests for influenza A+B by offering a combination of speed, accuracy and convenience with an objective read that physicians can trust," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "We believe the BD Veritor System has the potential to change the way doctors view in-office rapid flu testing."

The BD Veritor System rapid flu immunoassay reports performance measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available. This newly designed system incorporates BD's novel Nano Detection Particle and Adaptive Read Technology. With this unique combination of technologies in a CLIA-waived Flu assay, the BD Veritor System offers users:

  • A convenient workflow
  • Few, easy steps requiring very little sample preparation
  • No sample incubation required prior to running the test
  • Ten-minute period for the test to run and ten seconds of instrument read for final results.

The assay for rapid detection of Flu A+B on the BD Veritor System represents the first of many different assays that are planned on this new platform.

Friday, December 16, 2011

BAX® System Receives FDA Equivalence for Detecting Salmonella Enteritidis in Eggs

The U.S. Food and Drug Administration has awarded test method equivalency to the BAX® System from DuPont Qualicon for detecting Salmonella enteritidis in eggs.

Accuracy, precision and sensitivity of two BAX® System PCR assays – Salmonella and Salmonella 2 -- were determined equivalent to the reference culture method published in the FDA’s Bacteriological Analytical Manual. Moreover, results for both assays were available just 55 hours after sampling, instead of 7 or more days required by the culture method.

S. enteritidis, a foodborne pathogen most commonly associated with eggs, has been identified as the most frequent cause of Salmonella infection in Europe. In the United States, it’s responsible for 79,000 illnesses and 30 deaths each year. FDA regulations introduced in 2010 require egg producers to implement preventive measures and monitor for S. enteritidis with frequent testing.

“This FDA equivalence is welcome news for egg producers who prefer the BAX® System’s speed, accuracy and ease of use,” said Doris Engesser, global leader, DuPont Qualicon. “Significantly shorter enrichment with this method means that eggs can be released days faster, reducing inventory and refrigerated storage costs while helping to prevent contaminated products from reaching the food supply.”

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, E. coli, Campylobacter, Vibrio and more. With certifications and regulatory approvals in the Americas, Asia and Europe, the BAX® system is recognized globally as one of the most advanced pathogen testing systems available to food companies. DuPont Qualicon science-based systems for pathogen detection and microbial monitoring, together with Danisco Care4U™ range of natural food protection solutions, help companies protect their products, productivity and brands.

Wednesday, December 14, 2011

3M Food Safety Unveils Innovative Molecular Detection System for Dangerous Foodborne Pathogens

After decades of transforming the food processing industry with 3M™ Petrifilm™ Plates, 3M is once again revolutionizing the industry -- this time in the area of pathogen detection. Today, 3M Food Safety introduces the 3M™ Molecular Detection System: a fast, accurate and easy-to-use method of detecting dangerous pathogens, like Salmonella, E. coli O157 and Listeria, that can shut down businesses and threaten public health.

Available worldwide, the 3M Molecular Detection System is based on an innovative combination of unique technologies involving isothermal DNA amplification and bioluminescence detection. The system was designed with 3M's customer testing needs in mind, which translates into a compact, simple, robust system that offers easy implementation and low maintenance without compromising accuracy and reliability.

"Leveraging 3M's record of innovation, including close collaboration with our customers, we believe we've found a transformational solution that makes for a faster and simpler way of accurately detecting pathogens," said Francine Savage, vice president and general manager, 3M Food Safety. "Just as 3M Petrifilm Plates succeeded by melding sophistication with simplicity, the 3M Molecular Detection System optimizes technicians' time and productivity, improving bottom lines, protecting brands and ensuring public health."

The 3M Molecular Detection System delivers highly sensitive results by targeting and amplifying nucleic acid in enriched samples. The automated technology has been evaluated with a variety of food types, including produce, meats, processed foods, pet food and food processing-related environmental samples. The instrument is sleek and compact -- taking up less counter space than a laptop computer, making it portable and adaptable to various lab environments.

"Pathogen testing has now been made simple and affordable," said Niki Montgomery, 3M Food Safety global marketing development manager. "Food processors will benefit greatly from the system's affordable accuracy and fast time to results, minimizing downtime in the lab. Numerous organisms can be tested in a single run and it was designed to help our customers perform fewer repeat tests and make critical decisions faster."

As part of the 3M Molecular Detection System platform, individual, pathogen-specific assays, or procedural tests, will be sold as a test kits. Each assay test kit uses the same software interface and same DNA extraction protocol for testing between one and 96 samples per run. Assays for Salmonella, E. coli O157 (including H7) and Listeria are available immediately; a test for Listeria monocytogenes is expected in early 2012. 3M will continue to invest in developing a full portfolio of pathogen testing solutions to address customer needs.

Independent laboratory studies with the 3M Molecular Detection System are currently underway to pursue global method recognitions.

"In our evaluation of the Listeria species assay, we liked the small footprint of the system as well as the quick delivery of results after sample enrichment," said Dr. Martin Wiedmann, a professor in Cornell University's Department of Food Science who studied the system's analyses of samples taken from meat-packing, seafood processing and retail locations. "This system definitely illustrates the potential of isothermal methods for rapid detection of foodborne pathogens."

Market Report - Second-Generation Microbiological Tests Detect Pathogens Within One Day

Automated and rapid microbiological tests are rapidly adopting new technologies and automated techniques reducing the time required to detect pathogens from five to ten days to only one day in most cases. These second-generation microbiological tests are moving away from the first-generation technologies such as immunoassays, chromatography and polymerase chain reactions whilst adopting new advanced concepts of biotechnology and molecular diagnostics.

By the end of 2017, the automated and rapid microbiological tests market is forecast to be valued at US$4.5 billion. The increasing number of cases of infectious diseases and sexually transmitted diseases combined with the increased expenditure into developing quicker and more accurate methods of testing is driving growth in this market sector.

The United States is forecast to remain the largest regional market for automated and rapid microbiological testing. The market place is highly saturated and lowering costs of testing services is expected to spawn an era of vertical and horizontal integration across the market. Advancements in molecular diagnose such as genetic probe tests hold the key to dominating this market place, taking market share from players adopting the more traditional rapid microbiology tests approach.

In Europe, the microbiological testing market is forecast to increase by 5.6% with the other markets in Asia and Latin America also expected to report strong growth as the new technologies are implemented.

The largest end-use market sector is automated identification with GC / Chlamydia Rapid Tests representing the fastest expanding sector, growing at a strong rate of 5.3% CAGR. The main players in the automated and microbiological testing market are Abbott Laboratories, Alere Inc., Becton Dickinson and Company, bioMerieux SA, Bio-Rad Laboratories Inc., Cellabs Pty Ltd, Celsis International Plc, Coris BioConcept, F. Hoffmann-La Roche Ltd., Gen-Probe Inc., Sekisui Diagnostics LLC, MedMira Inc., Meridian Biosciences Inc., Orasure Technologies Inc., Orion Diagnostica Oy, Quidel Corp., Siemens Healthcare Diagnostics Inc., and Thermo Fisher Scientific Inc.

Leading Product Development Company Sagentia Selected by PathoGenetix to Develop Commercial-Scale, Rapid Microbial Detection System

Sagentia, an international technology and product development company, announced today that it has been selected by PathoGenetix to develop a commercial scale system for rapid microbial detection and strain typing based on PathoGenetix's Genome Sequence Scanning Technology (GSS). The system is being designed to capitalize on the broad range of potential GSS applications that span microbial genomics research, food and product safety, and clinical infectious disease testing.

PathoGenetix's proprietary GSS technology combines automated sample preparation and single molecule detection making it possible to detect and characterize microbes from complex biological samples in as little as three hours. Specifically, the technology extracts genomic barcodes from microbial DNA as it flows through a microfluidic chip at 150 million base pairs per second. A universal reagent set decorates the DNA enabling specific pathogens to be identified by comparing their unique DNA 'barcode' with PathoGenetix's own library of templates. With this approach, it is possible to identify thousands of different microbial strains through a single test, days faster and at far lower cost than current techniques. The GSS technology was developed with more than $50 million in support from the United States Departments of Defense and Homeland Security under advanced biosensor programs.

Sagentia, an experienced leader in the development of new technologies and breakthrough products, including complex diagnostics, was brought in to the project to take the current laboratory prototype and help turn it into a technically and commercially successful platform. Sagentia's work will include further integration of state-of-the-art optics and microfluidics, making the technology more robust, enhancing the usability of the system, driving cost reduction, and increasing manufacturing efficiency.

"Sagentia's commitment to PathoGenetix directly reflects our mission to help clients develop and deliver innovative technologies through all the stages of device development," said Brent Hudson, chief executive officer of Sagentia. "Working across the complete product development continuum - from market needs analysis to transfer to volume manufacturing - we make it possible for companies to take complex ideas and develop them into products that are robust and usable in many settings. We are excited to work with PathoGenetix and look forward to helping them bring this groundbreaking new technology to market."

"We are very excited to be working with Sagentia on this critical initiative," said John Canepa, chief executive officer of PathoGenetix. "At PathoGenetix, we are focused on revolutionizing microbial identification and diagnostics. We chose Sagentia because of the company's extensive technical knowledge and the team's understanding of our core objectives. We believe that Sagentia's team will add tremendous value to this project and we look forward to working with them to bring to market an instrument platform that will improve the speed and efficacy in a range of diagnostics applications." He added that PathoGenetix expects to launch the system's initial commercial application, for the research market, in late 2012.

This is another important client project for Sagentia as the company continues to grow its US footprint. In November of 2010, Sagentia expanded its presence in the U.S. by opening an office at One Broadway Street in Cambridge, Massachusetts where the company was selected to be a member of Governor Deval Patrick's U.S.-U.K. trade partnership.

Celsis Rapid Detection Launches Enhanced Software

Celsis, which provides rapid microbial testing systems for industry, released a new and enhanced version of Innovate.im software for the Celsis Innovate system that is used worldwide by dairy, food and beverage manufacturers to screen products for microbial contamination. The Celsis Rapid Detection system shortens product and ingredient testing times from 4-14 days to as few as 24-48 hours.

“Faster testing cycles help manufacturers be more responsive to customers, prevent contamination from spreading and reduce costs for inventory and warehousing,” said Scott Scdoris, Director of Food & Beverage for Celsis. “The new Innovate.im software also provides secure, remote and real-time access to testing data, so company executives are better prepared to monitor and respond to potential consumer health risks.”

Mary Kamm, director of research and quality at Byrne Dairy, said, “The new Celsis Innovate.im software allows us to more efficiently manage test results from our complex operations; thereby allowing us to ensure the highest standards of product quality for our customers. In particular we benefit from the new Celsis software being compatible with the new Windows operating systems, allowing us to upgrade our laboratory computers. It is also compatible with our LIMS system, allowing for efficient data transfer to our quality assurance testing database.”

Manufacturers of packaged dairy, food and beverage products that are expected to be free of microbial contamination can benefit from the rapid, absence/presence results offered by the Celsis system. The new software update provides additional support for high-volume packagers, allowing multiple instruments to write data to a single, searchable database.

Additional features of the new software include updated graphical user interface; improved database querying capabilities; new plate preparation features; beverage/juice protocols; new user-definable data fields; and an updated on-screen menu.

Friday, December 09, 2011

PositiveID Corp. Granted Patent for Portable Pathogen Detection from U.S. Patent and Trademark Office

Located in Delray Beach, Florida, PositiveID Corp. (OTCBB: PSID) develops unique medical devices and molecular diagnostic systems with their focus primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Yesterday, the young company took a major step towards prominence with the announcement they have been granted Company Patent No. 8,053,214 from the U.S. Patent and Trademark Office.

The patent was awarded to PositiveID’s MicroFluidic Systems (“MFS”), which is a subsidiary of PositiveID. MFS has a growing patent portfolio where the targeted applications of which are biological sample collection processing and detection from environmental samples and clinical samples. The patent will allow PositiveID to make a substantial impression within the sector and to take advantage of DHS’ $3 billion “Bio Watch Program.”

Leading the way at PositiveID is William J. Caragol whom serves as the company’s CEO. In reference to this press release, Caragol stated, “This latest U.S. Patent demonstrates the vast array of derivative technology stemming from M-BAND, a system developed under a decade of funding received from DHS exceeding $35 million. We believe M-BAND continues to be well positioned as a proven technology to compete for DHS’ Third Generation BioWatch program, a $3 billion program to identify pathogens in the air as part of an early warning system designed to thwart a potential terrorist attack.”

Thursday, December 01, 2011

Thermo Fisher Scientific makes it Easier to Test Food for Shiga Toxin-producing E. coli

The new BAX® System STEC Assay Suite includes a screening assay and two panel assays. The screening assay detects STEC virulence genes (stx1, stx2 and eae), quickly and conveniently ruling out negative samples. The panel assays determine which of the six clinically most significant STEC serogroups identified over the past 20 years (O26, O111, O121, O45, O103 and O14) a positive sample contains.

The BAX® System STEC Assay Suite is simple to use. Single-stage enrichment is complete in as little as nine hours. Dual tests for STEC and O157:H7 can be run from the same prepared sample (also used for the panel assays). With no need for additional sample prep between tests, hands-on time and the risk of cross-contamination are reduced. Rapid real-time processing delivers results in less than one hour, allowing food processors to make product-release decisions quickly and with confidence.

The BAX® System allows food laboratories to easily, quickly and accurately detect organisms in raw ingredients, finished products and environmental samples. The cycler/detector allows samples to be loaded and left to run. Interpreted results are clearly displayed on-screen, with raw data easily accessible.

The BAX® system decreases false positives and minimizes re-testing, it helps reduce employee training and increases product time to market. The speed and accuracy of DNA-based detection; the simplicity of the load-it and leave-it operation; the familiarity of the Microsoft™ Windows™ interface: The BAX® system combines all this, for smooth testing procedures at any stage in the processing pipeline.

Assays for the BAX® System Q7 include: Salmonella, Genus Listeria, Listeria monocytogenes, Escherichia coli O157:H7, Staphylococcus aureus, Campylobacter coli/jejuni/lari, E. sakazakii (Cronobacter), Vibrio cholerae/parahaemolyticus/vulnificus, yeast and mould and now the new, BAX® Real-Time STEC Assay Suite.

Contractors Selling Faster Way to Run DNA Tests

As DNA identification technology advances and becomes easier and quicker to use, contractors are finding sales opportunities at the Pentagon and other security agencies. Falls Church-based Northrop Grumman said last month that, partnered with IntegenX, it won a contract to supply a rapid human DNA identification system to the Army’s Biometrics Identity Management Agency.

Alan Leckenby, vice president of identity and business solutions for Northrop Grumman’s information systems business, said the award moves the company into a new area of biometrics. “Numerous local, state and national ... security agencies use DNA-based human identification to assist in decision-making,” he said. But “in the laboratory, it takes a long time to process DNA samples. ... Shortening up the timeline is critically important” on the battlefield.

Bethesda-based Lockheed Martin, too, is focused on more-rapid DNA testing. The company has been partnering with Zygem Microlab in Charlottesville for about four years to develop small plastic chips and an associated instrument that together allow for DNA testing. The chip uses microfluidic chemical processing — which refers to using very small samples and chemicals to conduct the analysis — to allow quick, portable and relatively inexpensive DNA testing.

Conventional DNA testing requires six pieces of pricey lab equipment and processing time of about eight to 10 hours, if there’s no backlog, said John Mears, director of biometrics and identity management solutions within Lockheed’s information systems and global solutions civil unit.

“We’re talking about being able to take something as simple as a cheek swab ... stick it in the machine and have a DNA identification in about an hour,” said Mears, noting that it does not require trained laboratory technicians. The technology is only designed at this point to analyze the DNA that allows for identifying an individual, but Mears said future applications could include verifying family relationships for immigrant petitions or identifying food pathogens. “We’ve gone through several revisions of the prototype,” Mears said of Lockheed’s product. “I expect we’ll have something that’s marketable by the middle of next year.”

Mears said the company sees the military, the Department of Homeland Security and the Justice Department as potential buyers.

Leckenby too said Northrop is seeing promise in the technology, particularly as the cost goes down as units are produced in larger quantities.

“I think the high degree of accuracy is going to be very appealing,” he said. “It is expensive upfront when you’re at this stage of development, but the prices have come way down and will continue to go down.”

China Health Labs & Diagnostics Ltd. Announces $10.1 Million Sales Order for its Food Safety Business

China Health Labs & Diagnostics Ltd. announced that it has secured a sales order of RMB 61.5 million ($10.1 million) for food safety testing equipment, lab management system ("LMS") software and hardware, and installation services from the Beijing municipal government, through a bidding agent, Oriental Scientific Instruments Import and Export Corporation. The sales order is for delivery in 2011, and includes a LMS software developed by the Company to connect all the Beijing food safety labs, enabling more efficient communications and operations.

This sales order represents growth of 100% for the food safety business compared to 2010, when the Company had revenues of $33.7 million of which 15% or $5.5 million was from the food safety business.

"Improving food safety is a high priority for the Chinese government at the central and municipal levels. The Chinese government established the State Council Food Safety Commission last year and this year, the SCFSC announced a five-year program for food safety education," said Wilson Yao, CEO of China Health. "We have used our expertise in lab management and design to assist the Beijing municipal government to establish an effective network of food testing labs that operate with our proprietary lab management system. In the future, we plan to use our track record in Beijing as a reference to expand our food safety sales to other cities in China."

In 2008, China Health entered the food safety market by installing food-testing labs mandated and paid for by the Beijing municipal government in response to concerns due to the growing number of high profile food safety incidents and the need to improve safety for the Beijing Olympics. In 2009 and 2010, the Company developed and provided food safety lab solutions, including the Company's proprietary LMS software, for major food distribution centres in Beijing and a mobile lab solution based on the need for on-site rapid testing, which generated increasing revenues in each year.

Currently, the Company's food safety lab solutions test for, among other things: (1) heavy metal residue, such as mercury, cadmium and lead; (2) pesticide residue, such as alpha-BHC, formothion, oryzalin, pyraflufen-ethyl, DDT and nitenpyram; (3) veterinary drug residue, such as ampicillin, amoxicillin, altrenogest and bacitracin; (4) pathogenic micro-organisms, such as salmonella, shigella, vibrio parahaemolyticus and clostridium botulinum; and (5) poisonous food additives, such as lean meat powder, melamine, plasticizer and malachite green. The food safety lab solutions include equipment assembled at the Company's Beijing manufacturing facility and sourced from other manufacturers. To date, China Health has installed 17 major labs, 250 mini-labs (in food distribution and manufacturing facilities) and supplied 17 mobile labs to the Beijing municipal government to improve food safety.

OraSure Technologies Receives CLIA Waiver for OraQuick(R) HCV Rapid Test

OraSure Technologies, Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick(R) HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

The OraQuick(R) HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus ("HCV"). The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes. With this waiver, the OraQuick(R) HCV test now can be used by more than 180,000 sites in the United States to test persons who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now extend to facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations and physician offices.

"Today, more than 4 million Americans are infected with hepatitis C and the vast majority do not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic."

"A CLIA waiver for our OraQuick(R) HCV test represents a critical milestone in our quest to make the test available to the widest possible range of at risk individuals in the U.S.," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The CLIA waiver will enable healthcare providers, those on the front lines of fighting this devastating disease, to use this simple and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed and treated."

As previously announced, OraSure has entered into agreements with Merck & Co. to collaborate on the development and promotion of the OraQuick(R) HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the United States and internationally. The approval of the CLIA waiver will now enable physicians to utilize the test in their office settings.

P&G Implementing Celsis ReACT Assay at Detergent Plants Worldwide

The Procter & Gamble Company is implementing the Celsis ReACT molecular assay at its liquid detergent manufacturing sites worldwide. The two-hour ReACT test is being used as a follow-up to Celsis' AKuScreen test, which P&G currently uses as a primary screen for the release of their products. AKuScreen is an adenylate kinase (AK)-based assay, which generates definitive microbiological test results in under 24 hours.

"P&G's reputation is founded on quality. We want to assure that the consumer gets a safe, reliable product," said Neil Lewis, Global Microbiology Delivery Organization Technical Leader, P&G. On the rare occasion when a product sample tests positive and further analysis is required, the Celsis ReACT RNA-based secondary assay is used to determine the possible source of an organism.

"In our validation of ReACT, we have found it to be more accurate than a standard Gram stain test which is what we use it for," said Lewis. "We've not only got a faster test, but we've got a better test. ReACT has a huge potential that I don't think we've started to fully understand yet, given we've only been using it for 6-9 months now," he added.

The ReACT product grew out of earlier collaborative discussions on how Celsis could help P&G's quality teams respond to potential problems faster while maintaining customer safety as a top priority.

"The global supply leadership team at P&G have been more than proponents and users of our rapid screening systems. They have been true collaborative partners with Celsis in helping to define our industry's next generation market needs," said Jay LeCoque, CEO of Celsis International Ltd.

Celsis ReACT is an easy-to-use molecular assay for detecting objectionable organisms quickly and definitively without the need for expensive equipment or specialized training. It is based on molecular technology that targets 16S or 18S rRNA to match a microbial classification or species using an integrated probe set.

Quidel Receives CE Mark for Its Sofia™ Strep A Fluorescent Immunoassay (FIA) Test

Quidel Corporation, a leading provider of diagnostic testing solutions, announced today that it has received the CE Mark for its Sofia Strep A FIA for use with its Sofia Analyzer.

Sofia is the brand name for Quidel's next generation, immunoassay system. The Sofia Analyzer and Sofia Strep A FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, rapid and highly accurate diagnostic result. This press release follows closely on the recent announcement of the FDA clearance of the Sofia Analyzer and Sofia Influenza A+B FIA.

The Strep A FIA is the second assay to incorporate Sofia-related immunochemistry. The CE Mark allows Quidel to launch the Sofia Strep A FIA just before the respiratory disease season in Europe as well as in other locations outside of the United States. The product is currently not for sale in the U.S.

"We are very pleased to receive the CE Mark for Strep A on Sofia ahead of schedule. In combination with our Sofia Influenza A+B FIA, this product will provide healthcare workers with added testing versatility during this respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation.

The Sofia Strep A and Influenza A+B FIAs use the Sofia Analyzer, an instrument that is designed to quickly incorporate software upgrades for new analyte-specific algorithms as the Sofia menu of products expands. The development of several additional FIAs for application to the Sofia Analyzer is well underway.

MicroVal Certifies GreenLight TVC Method for Raw Meat, Poultry

The GreenLight™ total viable count (TVC) method, which automatically detects microbial contamination in food and beverage samples, was recently validated and certified by MicroVal for raw meats and poultry. Based in The Netherlands, MicroVal validates and certifies alternative microbiological analysis methods according to EN-ISO 16140.

“After a successful launch in the United States, the MicroVal certification will now enhance our ability to market GreenLight™ series instrumentation across Europe. The rigorous independent testing that this methodology has gone through over the past two years, gives European food processors the confidence to convert to faster, more efficient technology,” says Dr. Richard Fernandes, chief executive officer, Luxcel Biosciences Ltd.

GreenLight™ sensor technology was developed by Luxcel Biosciences and has been marketed in the United States by MOCON, Inc. (NASDAQ: MOCO) since 2010. The methodology has been previously qualified by AOAC International, Gaithersburg, MD, which provides validation and conformity assessment of commercial and analytical methods.

As part of the MicroVal certification process, the microbial contamination methodology was tested at eight independent laboratories in five different European countries.

The GreenLight™ series was developed to provide precise, same-day results in a cost-effective manner. Depending on the bacterial load, results can be obtained between minutes and 12 hours. This is more than ten times faster than the traditional agar plate or film methods, which typically require 48 to 72 hours to achieve a meaningful microbial count. Shorter testing cycles provide packers and processors with the potential of getting their perishable food items to the consumer in less time.

“The rigorous independent testing of the GreenLight™ microbial test methodology provides further validation of its ability to perform precise tests for bacterial loads in raw meat and poultry. Additionally, GreenLight™’s outstanding time-to-result when compared to traditional methods enables us to play a key role in creating a safer world market for food,” Dr. Fernandes says.

Three different units, the GreenLight™ 910, 930 and 960 are available to handle a variety of throughput requirements. The series also targets company and laboratory microbial contamination testing requirements for seafood, dairy, produce, etc.

MicroVal certificate number RQA2008LR15 was issued to Luxcel Biosciences, Ltd. on October 11, 2011. The certification is valid for four years.

Wednesday, November 23, 2011

Ensuring a Safer Egg

In August 2010, an outbreak of Salmonella Enteritidis (SE) was responsible for illness in almost 2,000 people in at least 25 states. More than 550 million eggs were recalled from the market. While methods have been in place to test for the presence of SE in eggs, the traditional methodology is time consuming, requiring up to 10 days to determine the presence or absence of SE in egg samples.

Recognizing that this timeframe wasn’t acceptable, the microbiology laboratory at Penn Vet’s New Bolton Center has played a significant role in the development of rapid SE-specific molecular diagnostic methods. The polymerase chain reaction (PCR) test developed at Penn Vet allows quick determination of the presence or absence of SE in egg samples, and provides accurate results in approximately 27 hours – a tenfold reduction in waiting time for results.

This methodology came in handy for the Federal Egg Safety Program, which requires all large-scale producers in the US to test for SE before products reach consumers.

As a result, the Salmonella Enteritidis Detection Kit was developed by Shelley Rankin, PhD, associate professor of microbiology at Penn Vet and chief of NBC’s microbiology, in collaboration with The Life Technologies Corporation, which allows producers to quickly test their eggs for SE. FDA-approved for use in the Federal Egg Safety Program in early 2011, the kit was validated by Dr. Rankin’s lab.

“Penn Vet has been collaborating with the Commonwealth of Pennsylvania to ensure food safety for decades,” said Dr. Joan C. Hendricks, the Gilbert S. Kahn Dean of Penn Vet. “The adoption of our egg-testing protocols by the FDA illustrates our researchers’ success in their field and the importance that veterinary researchers play in ensuring public health and food safety. I am thrilled that Penn Vet is continuing to lead the way in setting the standard in food safety and public health.”

“The FDA equivalence determination for this test marks a milestone for the egg industry in this country,” said Dr. Rankin. “The Commonwealth was the first state in the nation to initiate a voluntary egg quality assurance program and the Pennsylvania Animal Diagnostic Laboratory System will be the first to implement this new level of testing. It's very exciting that the FDA has adopted this test for the Federal Egg Safety Program. This action demonstrates their commitment to delivering the safest quality food to the consumer and I'm proud to be a part of that trend.”

Penn Vet has been active in the development and implementation of the state’s PEQAP (Pennsylvania Egg Quality Assurance Program), and much of what has been learned and shared by PEQAP forms the basis for the national Egg Safety Program. Dr. Rankin has more than 20 years experience in the detection and characterization of Salmonella from human and animal sources.

Accelr8 Announces Development Expansion for Blood-Based Diagnostic Tests

Accelr8 Technology Corporation announced that it successfully completed two technical feasibility studies for test methods that expand its BACcel™ rapid diagnostic test library and automation capabilities. The first is a same-day multi-pathogen, multiple drug resistance diagnostic panel for positive blood cultures. Blood-borne infections produce extremely low bacterial or fungal counts in blood, so all blood tests require an overnight culture before testing. As with other specimen types, standard culture tests require colony isolation and then additional tests to identify pathogens and specific drug resistance expression. These require 2-3 additional days after obtaining a positive culture. Some of the new molecular diagnostic methods, such as mass spectrometry ("MALDI-TOF"), also require isolates and some require further sample extraction for best accuracy.

Accelr8 adapted its respiratory infection test methods to provide same-day results for positive blood cultures. The blood test panel includes multiple pathogens and multiple drug resistance types for each pathogen. The BACcel™ tests can report results by the end of the second day after obtaining a blood specimen, rather than 3-4 days.

The second project developed an innovative method for automating specimen preparation. Patient specimens typically contain a large proportion of materials that interfere with organism extraction or analysis. Reducing this content can markedly improve test accuracy for most test methods, including the BACcel™ system. Accelr8's new technology reduces the total preparation time from about 45 minutes with the existing respiratory specimen cleanup to less than 10 minutes. Development uses Accelr8's latest BACcel™ lab prototype fluidics robot to automate most of the operation.

The company believes that the new BAC-Xtrax™ device will completely integrate a "specimen-to-answer" automated BACcel™ system. It can also stand alone as a lab product, or integrate into other companies' automated systems for processing patient specimens.

"In addition to our own development plan, we've received requests from medical opinion leaders and from other companies for these new capabilities. We will submit presentations to major medical congresses where these advances will have the greatest impact," said David Howson, the company's president. "We continue to expand our network of medical and commercial collaborators as we enhance the BACcel's performance for long-term leadership in clinical diagnostic and pharmaceutical development markets. We are in dialogue with potential US, European, and Chinese collaborators," he concluded.

Kiestra Lab Automation: New Advanced Technologies in Microbiology Diagnostics

In the good old days, the microbiology laboratory used to be a labor intensive place equipped with incubators and microscopes. Microbiologists were patient scientists waiting at least 24 hours before their isolated cultures were grown enough for identification. Today, laboratory medicine is developing at a rapid pace and the microbiology lab is having its own evolution going on. Lab automation is emerging and processes are done faster than ever with more standardized and comparable tests. Samples are barcoded before they enter a string of analyzers measuring mass spectra, fluorescence and specific DNA sequences. Almost all serology tests run in multiplex (simultaneously measure multiple analytes) and high throughput machines that can produce about 1000 results in an hour. These are intelligent machines that can automatically expand tests depending on earlier results, for example repeat, reflex or add-on extra tests.

One of the companies involved in this laboratory revolution is Kiestra lab automation BV based in the Netherlands. They created a system to cover the whole process from inoculation to identification automatically.

Their slogan “It’s the sample that moves!” involves many features. The system starts with the ‘InoqulA,’ a full automatic inoculation machine, in which any fluid specimen will automatically be opened-inoculated-spread-sorted and transported to the incubators. This can be done at a high through-put rate of up to 400 inoculations per hour. It uses a new technology with magnetic rolling beads to streak the plates, this creates enough single colonies in various specified directions.

Your preferred identification and susceptibility methodology ( e.g. biochemical, Malditof, disc diffusion, etc. ) can be integrated within the system. A monitor dashboard can be installed in the laboratory in order to optimize workload management. In a blink of the eye each supervisor can see how many digital reads have to be done at which hour.

In order to create a 24/7 non stop laboratory, incubation, processing and digital imaging is performed non-stop day and night. Having digital images of each culture makes it possible to view them remotely. The use of smart-phones within bacteriology comes within reach: the ReadA Browser on the iPhone makes it possible to check your cultures from just about anywhere.

The company has developed a very informative video on the system, which includes a demonstration of automated sampling and spreading of the inoculum using the magnetic beads. You can view the video by CLICKING HERE.

Wednesday, November 09, 2011

3M Forced to Pay for Breach of Obligations Over MRSA - High Court

Investment fund manager Porton Group and the Ministry of Defence subsidiary Ploughshare Innovations* today won a court battle with 3M over the multi-national company's failure to promote a test for the "superbug" MRSA. The High Court in London found 3M was "in material breach of its obligation" under an agreement to actively market the product, BacLite.

Porton Group CEO Harvey Boulter said:- "I am delighted that we have been vindicated in our attempt to force 3M to face up to their responsibilities. "But the victims here are those infected with MRSA. A weapon in that fight was wrongfully abandoned by 3M. "This is a question of trust and honour which in my opinion seems to have been sadly lacking in 3M's behaviour. "The Judge has made it quite clear that 3M did not live up to its promises."

BacLite detects MRSA within 5-6 hours, a rapid detection time that could save lives around the world.

Judge Mr Justice Hamblen awarded Porton Capital Technology Funds, Porton Capital Inc and the Ministry of Defence's technology development arm, Ploughshare Innovations Ltd (hereafter "MoD"), damages of approximately $1.3 million ($1,299,808) in compensation. The Judge also said that Porton and the MoD had not been unreasonable when they objected to 3M's decision to shut down the project on December 31 2008, just a day before a 12-month earn-out period, under which the sellers would be paid part of the profits, began. The issue dates back to February 2007 when 3M agreed to buy a company called Acolyte Biomedica - part-owned by Porton and MoD - set up to exploit the BacLite technology.

3M convinced Acolyte that 3M had the medical device expertise and the global sales and marketing expertise to take over successful sales of BacLite worldwide and specifically in four major markets - the EU, including the UK, the US, Canada and Australia. But the Judge said that 3M was not only in breach of its obligation to "actively market" BacLite but also failed to gain regulatory approval in the US. "I find that from the end of March 2008 3M was in breach of its obligation diligently to seek regulatory approval for BacLite in the US and that had it complied with its obligation such approval would have been obtained by the beginning of February 2009," the Judge said.

The test was originally developed by the British Government's Defence Science and Technology Laboratory at Porton Down, Wiltshire, to detect biological weapons.

In the course of the trial, the Judge heard that 3M's original estimate of the earn-out payment under the Share Purchase Agreement in January 2007, a month before the purchase, was $33 million. While the companies and the MoD were not unreasonable to reject 3M's decision to close down the project, he added: "It was also reasonable for them to suspect that the failure of the business had been contributed to by 3M's own breaches of the SPA."

Referring to 3M's compensation offer before the trial, the Judge went on: "The reasonableness of the vendors' refusal is borne out by the fact that there were a number of 3M estimates at the time which exceeded the figure offered and that the figure was meant to be conservative." The failure by 3M "diligently" to pursue approval for BacLite by the US regulator - the Food and Drug Administration ("FDA") - after March 2008 was an important element in the project's termination, the Judge said. [166]. The judge found that 3M could have achieved US FDA regulatory approval by February 2009 "at the earliest" if they had corrected their own errors. Despite having identified problems with the methodology of the pre-approval testing, which had been changed by 3M from that carried out originally in the UK, and with 3M scientists suggesting solutions, there were concerns at the highest level in the company that the project was not making money fast enough. In an internal email of 7 March 2008, the Judge said, 3M's chairman and Chief Executive Officer, George Buckley, since awarded a knighthood, suggested "pulling the plug." A day later he said in another email he stated "tell them to deliver or tell them that we are likely pulling the plug" and warned "its time to fish or cut bait."

Micro Imaging Technology Updates the Status of the MIT 1000A Accompanying Family of Bacteria Identifying Software

Micro Imaging Technology, Inc. today provided an update on the family of bacteria identifying software that accompanies the MIT 1000A. The System, manufactured exclusively for MIT by Hawthorne, CA-based OSI Optoelectronics, Inc., is a stand-alone optically-based bacteria identification system that uses proven principles of physics in conjunction with proprietary PC-based software and is USB compliant. The MIT 1000A can complete an identifying test in less than five (5) minutes and with a material cost of pennies -- adding further credence to MIT's claims of being able to annually save thousands of lives and tens of millions of dollars in health care costs with their unique technologies.

As explained by MIT's Chief Scientist, David Haavig, PhD: "In the US, around 76 million cases of food borne illnesses, resulting in 325,000 hospitalizations and 5,000 deaths, are estimated to occur each year. The leading cause of these illnesses and deaths are three main strains of bacteria: E. coli, Salmonella, and Listeria. Rapid identification of these disease causing pathogens in food is critical to the health and safety of all consumers."

Dr. Haavig further explained: "The AOAC Research Institute (AOAC RI) awarded the Company, in June 2009, Performance Tested MethodsSM (PTM) certification for the rapid identification of Listeria. The AOAC RI provides an independent third-party evaluation of methods and will award PTM certification to methods that demonstrate performance levels equivalent or better than other bacteria identifying methods. The MIT System underwent hundreds of individual tests over an eighteen-month period to earn AOAC RI's certification for the identification of Listeria; including evaluations of hardware, software, ease of use, documentation, ruggedness and accuracy."

Michael Brennan, MIT's Chairman, expanded on the Certification status: "MIT will begin the process of earning Performance Tested Methods Certification from the AOAC RI for the identification of E. coli and Salmonella in December, 2011. This certification process is far less difficult than the original Listeria certification. All hardware, software, documentation, and test procedures are identical to the Listeria certification process. The only items to prepare are the E. coli and Salmonella Identifiers, or database component, that should be concluded by early December."

Pall Corp. Showcases New Beverage Production Technologies at Brau Beviale

Pall Corporation will introduce new developments for beer and beverage production at Brau Beviale, November 9-11, 2011 in Nuremberg, Germany. The company also will hold a panel discussion on the subject of kieselguhr-free beer filtration on November 9th. During the discussion, users of PROFi technology will have the chance to share experiences with beer filtration experts.

Innovations being spotlighted by Pall during the show include the Pall GeneDisc(R) Rapid Microbiology System.

Pall's GeneDisc system is a new easy-to-use instrument for quick and reliable detection of beer-spoiling microorganisms. Based on real-time PCR technology, the flexible, modular GeneDisc system helps optimize work flow and offers the capability to process different applications simultaneously. Its intuitive touch-screen interface and built-in, user-friendly software and barcode reader allow for easy adoption of the technology. A clear, straightforward display of results enables minimally trained personnel to routinely perform sophisticated biological sample testing for rapid decision-making.

The Pall GeneDisc system recently helped German authorities screen for a deadly strain of E.coli that disrupted the nation's food industry. The technology was used by Germany's national reference laboratory to expedite testing of food samples for the toxic strain of the pathogen known as E.coli O104:H4 (STEC).

Contaminated Food Leads To About 2ΜΝ Deaths Annually Driving Increased Demand For Agricultural And Environmental Diagnostics

The WHO estimates that approximately 2 billion illnesses and 1.8 million deaths on an annual basis are a direct result of contaminated food. The pathogens such as E. Coli, listeria, salmonella and others are linked to food borne illnesses and the increased prevalence of these pathogens are driving the necessity or improved scientific and technological solutions to test agriculture and environmental hygiene in the human food chain.

By 2017, the agriculture and environmental diagnostics market is forecast to be valued at US$3.8 billion. Strong growth in the agricultural and environmental diagnostics market is due to rising concerns over food and water safety and increasingly stringent controls and regulations on food safety and agricultural practices. The technological advances in testing equipment is also expected to drive increases in market value for the agricultural and environmental diagnostics market.

Food testing laboratories are benefiting from the increased food production and more intense agricultural practices which subsequently placing more importance on controlling and monitoring food safety worldwide. The increased connectivity of food distribution and centralised nature of food production results in the need for more control over food safety and diagnostic testing. One small issue on a single food source could have implications on a national or even worldwide scale due to the complex distribution networks currently in operation.

The agricultural and environmental diagnostics market deals with food product examination for the presence of disease-causing organisms, chemical residues, and other hazardous materials in food. Testing of food products is gaining prominence worldwide, owing to increasing consumer awareness on health concerns, growing demand for specialist diets in developed markets, and an increasing demand for cheaper, convenience food.

Europe represents the largest market for agricultural and environmental diagnostics, with the United States in second place. Asia-Pacific region is forecast to report an annual growth rate of 11 percent during the period 2011 to 2016. In terms of a particular testing segment, Microbiology represents the fastest expanding sector.

The requirement for more rapid testing in microbiology, is expected to drive a faster growth in revenues within the diagnostic industry, purely because the technology required to turnaround results in a timely manner are more expensive than the more traditional methodologies. Rapid testing diagnostic methods are forecast to increase their market share of the total diagnostic market.

The major players in the agricultural and environmental diagnostics market are 3M Company, Agdia Inc., Biocontrol Systems Inc., Biomerieux SA, Charm Sciences, C-Qentec Diagnostics, Eurofins Scientific Inc., IDEXX Laboratories Inc., Neogen Corp., R-Biopharm, Strategic Diagnostics Inc., Vicam.

Monday, November 07, 2011

Neogen Develops Quicker Test for Yeast and Mold

Neogen Corporation has developed an even quicker method to rapidly and accurately detect yeast and mold in food products. Neogen's new Soleris® test detects yeast and mold in 48 hours or less -- conventional methods take up to 5 days.

Tests for yeast and mold comprise approximately 15% of all microbiological tests performed worldwide. While it does not present the acute health threats of foodborne pathogens, spoilage caused by yeast and mold is one of the leading causes of food loss. Yeast and molds are a large and diverse group of microorganisms that can cause various degrees of deterioration and decomposition of foods.

"With the recent marking of global population at 7 billion, reducing food loss is becoming more critical than ever," said James Herbert, Neogen's chairman and CEO. "The United Nations estimates that approximately one-third of all the food produced annually is lost or wasted before it is consumed. The use of our new Soleris test can help reduce that loss, and ensure the quality and shelf-life of a wide variety of food products."

The new test is a Soleris direct vial system that can detect one colony forming unit (CFU) of yeast or mold per sample vial in 48 hours or less -- 24 hours faster than the previous rapid yeast and mold assay, and days faster than most tests. Neogen's new test also requires less technician time.

The Soleris system is a rapid optical method for the detection of microbial contamination based on an innovative application of classic microbiology. Soleris enables operators to release products quicker, saving the organization inventory costs, and allows operators to easily identify, monitor, and map problematic spots in their facilities.

In addition to the yeast and mold test, Neogen's Soleris system provides the quickest automated quality indicator tests for:
  • E. coli results in 7-10 hours; conventional methods can take up to 4 days
  • Total viable count (TVC) results in as little as 6-8 hours; conventional methods take 24-48 hours
  • Coliform results in 9-10 hours; conventional methods take 24 hours
  • Lactic bacteria results in 30-35 hours; conventional methods take 3-5 days
The independent testing laboratory AOAC-Research Institute has recently validated the performance of another of Neogen's test kits, its Soleris test that detects E. coli in as little as 7 hours (Performance Tested Method(SM) No. 101101). Most food companies and testing laboratories regard AOAC approval as a requirement for their use.

"Each time we receive a validation from an influential third party on any of our tests, it provides further assurance to our many customers that our tests perform as expected. We expect no less, and neither should our customers," said Herbert.

The results of a rigorous AOAC-RI validation study clearly indicate the Soleris E. coli method can be used for rapid and accurate detection of E. coli in a variety of food commodities. The Soleris test offers significant time savings of up to 3 days over the conventional reference procedure, while also reducing the amount of technician labor required. Neogen has also received AOAC-RI validation on its Soleris test for coliforms.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company's Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. Neogen's Animal Safety Division manufactures and distributes a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

GenturaDx Latest Patents Cover Innovations in the Automation of Sample Preparation

Molecular diagnostics company GenturaDx today announces that it has been awarded two additional patents from the United States Patent Office related to the company's IDbox™, it's fully-integrated molecular diagnostics platform. These two new patents (U.S. Patent Nos. 7,910,062 and 8,029,746) relate to GenturaDx's proprietary method of manipulating paramagnetic particles inside a closed cartridge for the purpose of purifying nucleic acids, and expand the company's total number of issued U.S. patents to four. The company's proprietary method of purifying nucleic acids is fully integrated with amplification and detection capabilities within the IDbox™ instrument and consumable cartridge and enable the platform to detect a broad range of pathogens from a wide variety of starting sample types.

"Our focus on nucleic acid purification is the cornerstone of our highly flexible system," said GenturaDx Chief Scientific Officer Jesus Ching, Ph.D. "These latest two patents are part of our long term strategy of targeting and acquiring key patents and licenses to support our proprietary cassette and fully integrated platform."

GenturaDx's fully automated molecular diagnostics platform, the IDbox™ System and its initial HSV 1&2 assay, are currently in beta testing, with clinical trials beginning in 2012. The IDbox™ System's integrated and automated design brings rapid, cost-effective, high performance molecular testing capabilities to hospital labs seeking to further automate existing molecular testing or bring testing in house.

"The addition of these two patents support our goal of developing a more effective, flexible and practical system that is protected by strong IP," said GenturaDx CEO Mark Bagnall. "GenturaDx has already benefitted from a license to proprietary PCR technology and continues to pursue additional patents. Our success at obtaining the initial four patents provides exciting momentum as we build our long-term portfolio."

GenturaDx is a molecular diagnostic company focused on making high-performance molecular diagnostics both affordable and practical for any laboratory to perform. The company is developing a fully integrated, automated instrument that conducts testing using a single-use cassette. This platform will make rapid, high-quality molecular diagnostics accessible to hospitals and patients worldwide - circumventing long-standing barriers of costs, automation and performance. GenturaDx's compact, self-contained platform incorporates sample preparation with proprietary, real-time PCR amplification and detection, reducing the risk of contamination and saving time. The platform's unique engineering design and intuitive interface relies on semi-batch processing capability while improving clinical value by offering multiple molecular targets in a single test.

Friday, November 04, 2011

The Institute of Bioengineering and Nanotechnology's MicroKit Wins Asian Innovation Award

The Institute of Bioengineering and Nanotechnology (IBN), is pleased to announce that its disease diagnostics technology, the MicroKit, has won the Silver Award at the Asian Innovation Awards 2011 organized by The Wall Street Journal Asia. The result was announced yesterday evening at the awards ceremony held at the Four Seasons Hotel in Hong Kong, which was officiated by Sir John Major, former Prime Minister of the United Kingdom.

The Asian Innovation Awards recognize innovations that break with conventional processes in creative ways. Developed in Singapore by IBN Executive Director, Professor Jackie Y. Ying and her team members, Guolin Xu and James Tseng-Ming Hsieh, the MicroKit is an automated diagnostic device that can detect viruses rapidly and accurately within two hours. Current efforts to contain infectious diseases are often hampered by the time it takes to diagnose and isolate those carrying the virus. Conventional diagnostic tests can take up to half a day and can only be conducted in dedicated biosafety laboratories by clinical personnel, who might risk accidental exposure to the virus.

Designed to enable diagnosis outside the laboratory, the MicroKit is portable and easy to use for non-clinical personnel. The MicroKit simplifies disease detection by integrating the sample preparation, amplification and detection processes in a disposable polymer cartridge. As everything takes place within the completely sealed cartridge, the risk of potential virus exposure is minimized. This portable device can be used at airports, borders, checkpoints and clinics to help contain the rapid spread of infectious diseases and prevent pandemics.

"We are delighted to receive the Silver award for the MicroKit. Our device aims to diagnose infectious diseases safely and quickly. Such diagnostic kits really help towards curbing the spread of diseases such as H1N1. This invention is the result of multidisciplinary research and reflects IBN's mission to develop innovative biomedical devices that will improve healthcare and benefit society," said Professor Jackie Y. Ying.

Now in its 12th year, The Wall Street Journal's Asian Innovation Awards attracted 256 entries from 18 countries and territories in the Asia Pacific region this year. The Asian Innovation Awards is committed to finding the next big technological ideas in Asia. This year's entries have been shortlisted based on three criteria: level of creativity or degree of innovation, quality of execution, and potential impact on quality of life or productivity. The awards were open to individuals, small businesses, large corporations or academia in Asia Pacific. IBN's MicroKit was one of the 12 finalists selected, and one of 5 finalists from Singapore. Please refer to the Annex for information on the judging panel for the awards.

IBN licensed the MicroKit technology to SG Molecular Diagnostics Pte Ltd in January 2009 to develop a range of diagnostic devices. The Institute is also working on the nextgeneration MicroKit, which will process 20 samples for 25 different diseases simultaneously.

Wednesday, November 02, 2011

PathoGenetix Inc. Raises $7.5 Million in Second Closing of Series B Financing for Rapid Bacterial Identification System

PathoGenetix Inc., today announced that the Company received $7.5 million in the second closing of its Series B financing to support the development and commercialization of its Genome Sequence Scanning technology for bacterial strain identification. Along with the $4 million raised in the first closing, announced August 1, 2011, the Series B round totals $11.5 million. New investor Ascension Health Ventures (AHV) participated in the financing through its second fund, CHV II, L.P., along with the existing investor group, which includes Excel Venture Management, CB Health Ventures, and HealthCare Ventures.

The Company's Genome Sequence Scanning (GSS) technology provides a broad platform for the rapid identification of bacterial strains in a wide range of settings. The technology enables simultaneous identification and characterization of thousands of bacterial strains in a single test in three hours. Applications include microbiome research, clinical diagnostics, antibiotic development, detection of bacterial contamination in food and pharmaceutical products, and biothreat detection.

"PathoGenetix's technology has demonstrated great potential to fill enormous needs in healthcare and public health to accelerate decision making, improve outcomes, and reduce unnecessary costs," said Dr. Tara Butler of AHV. "Delayed or incorrect diagnosis results in more than 100,000 deaths in the U.S. annually from hospital acquired infections and billions of dollars in costs. Food borne pathogens present a large and growing problem that result in more than 325,000 hospitalizations every year and 5,000 deaths."

"The funds will allow us to complete development and begin commercializing GSS in the rapidly emerging research market for analysis of microbial populations," said John J. Canepa, PathoGenetix CEO. "The addition of Ascension Health Ventures to our strong investor group will also enable us to leverage expertise from the more than 200 acute care hospitals within its limited partner base."

The GSS technology was initially developed with more than $50 million in support from the United States Departments of Defense and Homeland Security under their advanced biosensor programs. The technology extracts genomic barcodes from microbial DNA as it flows through a microfluidic chip at 150 million base pairs per second. Complex clinical specimens can be scanned to identify pathogenic strains days faster and at lower cost than current diagnostic techniques.

PathoGenetix is developing an automated system for the rapid identification of bacterial strains using proprietary Genome Sequence Scanning Technology. The company's approach, which employs a single reagent set to generate genomic bar codes based on bacterial DNA, can cost-effectively identify thousands of strains in a single test from complex samples in three hours. PathoGenetix is developing its GSS platform for use in genomics research, food and product safety testing, and clinical infectious disease diagnostics, with initial commercial introduction into the research market planned for late 2012.

Experts Report That Abbott’s New PLEX-ID Assay Offers Important Testing Capabilities For Biothreat Defense

Abbott’s PLEX-ID system provides reliable and rapid results for key microbial biothreat agents and should be considered as a first line analytical tool for biodefense, biosecurity and microbial forensics programs, according to research presented at the 13th Medical Biodefense Conference in Munich. The meeting is a global congress for civilian and military researchers covering the latest developments in the diagnosis, therapy and prevention of diseases caused by dangerous pathogens.

“An essential component for robust defense against bioterrorism is to develop rapid microbial forensic diagnostic capabilities so threats can be identified with prompt and appropriate actions taken in response,” said Bruce Budowle, Ph.D., professor, forensic and investigative genetics, University of North Texas Health Sciences Center, speaking at a symposium sponsored by the German Society for Military Medicine and Pharmacy. ”The PLEX-ID is a versatile instrument system and when coupled with the Biothreat Assay showed broad detection capability for a wide range of deadly and crippling microbes that could be used in a bioterrorism attack.”

The PLEX-ID Biothreat Assay rapidly identifies 17 different biothreat pathogens without the need for time consuming culture testing. A variety of specimens including blood, food, water, and air filter samples can be analyzed, and definitive results can be generated in less than eight hours.

Carson D. Baldwin, Ph.D., research chemist, U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), presented results of an evaluation of the PLEX-ID Biothreat Assay in which several different panels of specimens were analyzed utilizing the Biothreat Assay. The specimens contained pathogenic bacteria and viruses that could be used by terrorists to cause anthrax, cholera, and other diseases. In the evaluation, PLEX-ID correctly detected and identified all the targeted bacteria and viruses including several important subspecies.

Rapid identification and characterization of potential biothreat agents is critical and was cited by speakers at the Medical Biodefense Conference as an attribute of the PLEX-ID system.

The PLEX-ID system combines the sensitivity of nucleic acid amplification with the accuracy of high-performance electrospray ionization mass spectrometry followed by base-composition analysis to identify a broad array of microorganisms, including bacteria, viruses, fungi, and parasites. Certain PLEX-ID assays also provide information about drug resistance, virulence, and strain type. Anticipated public health and biodefense applications include epidemiologic research and identification of emerging or previously unknown agents. In addition, the system is being used for forensic characterization of human samples. In 2009, PLEX-ID was recognized by both The Scientist and the Wall Street Journal as a top scientific innovation of the year. Since its development in 2005, PLEX-ID technology has been deployed in sites around the United States, including the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.

Tuesday, November 01, 2011

Local Researchers Cook Up Qay to Reduce Food-Borne Illnesses

Crystal Diagnostics is trying to beef up the nation’s food safety with a locally developed technology. The company unveiled a new system on Wednesday that uses liquid crystals to help quickly detect potentially deadly food-borne pathogens in meats, produce and other products.

Researchers at Kent State University and the Northeast Ohio Medical University (Neomed) invented the biosensor technology used in the testing system, known as the Crystal Diagnostics MultiPath System. Unlike other rapid tests on the market, the MultiPath System can be used to detect multiple pathogens at the same time, said Paul Repetto, chief executive of Crystal Diagnostics. Results are available within 30 minutes, compared to 24 to 48 hours for traditional testing methods that rely on growing cultures of contaminating bacteria, Repetto said.

“It promises to save lives, and what could be more important than that?” Kent State University President Lester A. Lefton said on Wednesday during an event at Crystal Diagnostics’ manufacturing facility in the Kent State University Centennial Research Park. The goal is to have the food-safety system on the market next year after a round of beta-testing with national food producers and processors is complete. The company is trying to capture a piece of the growing food testing market, which Repetto estimates at $3 billion to $4 billion annually.

Deadly outbreaks of food-borne illness threaten customers’ health, as well as the financial health of food producers and processors. According to the U.S. Centers for Disease Control and Prevention (CDC), food-borne pathogens cause about 48 million illnesses, 128,00 hospitalizations and 3,000 deaths nationwide each year. Most recently, a multistate outbreak this fall from tainted cantaloupe from Colorado sickened 133 people and killed 28, according to information released this week by the CDC.

The Crystal Diagnostics Multi-Path System works by using a five-cell, disposable test cassette that contains liquid crystals inside a laminate casing. Liquid crystals are commonly used in such items as television screens and computer monitors.

Before testing, a food sample is smashed into a thick slurry, said Dan Minardi, Crystal Diagnostics’ president and chief technology officer. Antibodies for the bacteria being tested, such as E. coli or listeria, are added before the liquefied mixture is placed in three of the test cells (the two remaining cells serve as controls). The test cassette then is placed in a reader, which can display results on an iPad, computer screen or smart phone.

“This is groundbreaking technology in food-safety testing,” Minardi said. “It’s reliable, it’s cost-effective and it’s easy to use.” If the bacteria are present, the antibodies will clump and distort the liquid crystal matrix, explained Gary D. Niehaus, Crystal Diagnostics’ chief scientist and a professor of physiology at Neomed. As a result, the reader will detect light passing through and give a positive result.

Initially, at least, the Crystal Diagnostics MultiPath System is being marketed to food producers and processors for optional testing, Niehaus said. But the technology also could have future applications for everything from water safety testing to rapid-result testing in physicians’ and veterinarians’ offices. A price for the one-time use test cassette and reader hasn’t been set, Repetto said. However, he added, the cassettes likely will be more cost effective than currently available rapid tests, which can only be used to detect one pathogen at a time.

Kent State and Neomed (formerly NEOUCOM) have a licensing deal with Crystal Diagnostics that includes royalties from sales, said Maria Schimer, general counsel for Neomed and board chair for Crystal Diagnostics. “Then we’ll be able to plow that back into the research enterprise.” The universities also each have a 3 percent ownership stake in the company, officials said. Crystal Diagnostics has offices in Broomfield, Colo., a bioscience laboratory at Neomed in Rootstown Township and the manufacturing facility in Kent. The $3 million Kent facility has the capacity to eventually make 1 million testing cassettes annually, Minardi said. Local employment is expected to grow from the current six to at least 20 as production increases. So far, Crystal Diagnostics has secured $8.5 million in private-venture funding and $3.5 million in state grant funding, Schimer said.

The project is a good example of ongoing efforts to translate laboratory findings into products that can create jobs and generate alternative funding for universities at a time when state support is shrinking, Neomed President Dr. Jay A. Gershen said. “We try to take the great ideas of faculty and bring them to the mainstream of commerce,” he said.

FDA Approves Gen-Probe's APTIMA® HPV Assay, New Molecular Test to Detect Virus that Causes Cervical Cancer

Gen-Probe, a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility, has announced that the US Food and Drug Administration (FDA) has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe's fully automated, high-throughput TIGRIS instrument system.

Gen-Probe's TIGRIS system is the first fully automated, high-throughput molecular testing system, and the only one approved for use with an HPV test. More than 200 TIGRIS systems are being used by US clinical laboratories. The system has been cleared by the FDA to test for: Chlamydia and gonorrhea, two common bacterial sexually transmitted diseases (STDs), with the APTIMA Combo 2, APTIMA CT and APTIMA GC assays; Trichomonas vaginalis, the cause of a common parasitic STD, with the APTIMA Trichomonas assay; Human papillomavirus, with the APTIMA HPV assay.

"We believe our APTIMA HPV assay will offer physicians and patients a more accurate screening test for cervical cancer, and significantly improve testing efficiency for our laboratory customers," said Carl Hull, Gen-Probe's president and chief executive officer. "FDA approval represents a major milestone for the Company, since developing the APTIMA HPV assay was the largest and most complex diagnostic R&D programme we have ever completed."

The APTIMA HPV assay detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Testing is performed from ThinPrep liquid cytology specimens routinely used for Pap testing. Unlike other FDA-approved, DNA-based HPV tests, the APTIMA HPV assay detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.

"Most HPV infections clear up on their own, so it's important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer," said Tom Wright, MD, professor of pathology and cell biology at the Columbia University Medical Center. "In numerous clinical studies involving approximately 45,000 women, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test. This means the APTIMA HPV assay is highly accurate in detecting cervical disease, but is less likely to raise false alarms that can result in unnecessary medical procedures."

The APTIMA HPV assay is approved to test women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of pre-cancerous changes, and to screen women age 30 and older as an adjunct to Pap testing. This means the assay can be used to meet consensus guidelines for cervical cancer screening recommended by leading US medical organizations. "Physicians can use the APTIMA HPV test to make early, more accurate decisions about patient care, which in turn may prevent many women from developing a potentially deadly disease," Dr. Wright said.

FDA approval was based on data from the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, which analyzed approximately 11,000 women undergoing routine Pap testing at 18 US clinics. In the study, the APTIMA HPV assay showed similar sensitivity for the detection of cervical disease as an FDA-approved, DNA-based test. However, the specificity of the APTIMA HPV assay was higher than that of the DNA-based test, and this advantage was statistically significant.

NanoLogix Technology Delivers Live Tuberculosis (TB) Detection Results in a Revolutionary 4 Days versus Traditional 21 Days

NanoLogix, an innovator in the rapid detection, identification and antibiotic sensitivity determination of live bacteria announced today third-party results for detecting live Mycobacterium tuberculosis (TB) in a revolutionary time of 4 days with its BNP (BioNanoPore) technology. The advanced culture test results with the NanoLogix BNP technology are at least 500% faster than the 21-day standard for live TB culture detection. Additionally, other test methods for tuberculosis are expensive, labor intensive and cannot determine if a microbe found in a sample is living or dead. The NanoLogix technology provides a significant advantage over conventional methods for detecting TB in developing regions where medical resources are scarce and TB infections are rampant.

The 4-day TB results are a part of a lab research study conducted by a well-respected third party laboratory. The organization maintains anonymity until research data is published in a leading scientific journal.

"We are ecstatic over the third-party 4-day TB test results," said Bret Barnhizer, CEO of NanoLogix. "Typically, physicians must wait at least 21 days to determine if a patient should be put on antibiotics for TB. With an annual death toll of well over one million from this devastating disease, providing definitive, viable determination of TB in 4 days is a true game-changer."

The World Health Organization estimates that roughly one third of the world's population is infected with TB, either in an active or latent form. Highly contagious, active tuberculosis infections commonly attack the lungs and have a 50% mortality rate. In recent decades, the misdiagnosis and mismanagement of TB infections have led to a number of antibiotic-resistant strains, such as Mutli-Drug Resistant Tuberculosis and Extensively Drug Resistant TB.

Because of its slow growing nature, speeding up the definitive diagnosis of live-cell TB detection has been a consistent challenge for the medical industry. While techniques such as X-ray examinations, smear tests and DNA sequencing have provided alternatives to 21 day culture results, their inability to differentiate between the simple presence of a bacteria and a true active infection have left them unable to provide a comprehensive tool for fighting TB.

"By making the 'gold standard' method of culturing a faster process, our technology has the potential of providing the medical community with an extremely rapid, accurate, affordable and definitive culture-based TB test," continued Barnhizer. "With NanoLogix, physicians will soon have the opportunity to detect live TB faster, administer antibiotics properly, and monitor the efficacy of antibiotics in a close to real-time mode. This will provide the opportunity to reduce the prevalence of TB infections around the world."

Thursday, October 27, 2011

Expanded Database Advances Identification Capabilities of the DuPont™ RiboPrinter® System

DuPont Qualicon has added over 1,500 patterns to its RiboPrinter® System database, providing pharmaceutical and food companies, public health practitioners and epidemiologists with more of the information they need to identify contaminating bacteria in their production environments.

With the DUP 2011 update, the RiboPrinter® System now contains over 8,500 RiboPrint™ patterns or “fingerprints” of bacteria in its onboard reference database. Many of these new patterns, such as Corynebacterium and Bacillus, are of significant value to the pharmaceutical sector.

From a simple colony pick, the RiboPrinter® System produces a distinct genetic pattern that differentiates the bacteria at or below the strain level. Associated historical data determine where it came from and if it has ever been run on the system before.

This enables users to map the baseline flora of their facilities and monitor change so that they can spot trends, track contaminating events to their source and perform targeted remediation instead of larger production shut downs.

“We are continuously improving our products to meet evolving customer needs,” said Meg Rutherford, product manager, DuPont Qualicon. “In addition to this expanded database, we've also optimized many of the reagents and other disposables used with the system for greater efficiency and superior quality.”

Along with the RiboPrinter® system, DuPont Qualicon markets the award-winning BAX® system, an innovative DNA-based technology for detecting pathogens and other organisms in food and environmental samples. With certifications and regulatory approvals in the Americas, Asia and Europe, the BAX® system is recognized globally as one of the most advanced pathogen testing system available to food companies. DuPont Qualicon science-based systems for pathogen detection and microbial monitoring, together with Danisco Care4U™ range of natural food protection solutions, help companies protect their products, productivity and brands.

Free Trial of the BAX® System Q7 for Food Laboratories in Europe

Thermo Fisher Scientific are offering a free trial of the DuPont Qualicon BAX® System Q7 for food laboratory customers in Europe.

Ensuring that products are pathogen-free quickly and accurately is vital to food manufacturers and contract testing laboratories. PCR testing is rapidly becoming the gold standard in pathogen testing for its unrivalled sensitivity and speed. But if you thought PCR testing was too complicated, this free trial offer enables you to think again - try the BAX® System Q7 is to see how easy it is to use. With no centrifugation or washing steps required, sample preparation is simple.

PCR reagents are tableted and preloaded to minimize pipetting steps. Intuitive user interface software means test set up and reading couldn't be easier.

The BAX® System allows food laboratories to quickly and accurately detect organisms in raw ingredients, finished products and environmental samples. The cycler/detector allows you to load your prepared samples and walk away. Interpreted results are clearly displayed on-screen, with raw data easily accessible.

Food testing laboratories around the world have made the BAX® system an integral part of their quality assurance systems due to its tremendous impact on their operations - from dramatically decreased false positives and minimized re-testing, to reduced employee training and faster product time to market. The speed and accuracy of DNA-based detection, including a license to perform PCR; the simplicity of a load-it and leave-it operation; the familiarity of a Microsoft™ Windows™ interface: The BAX® system combines all this, for smooth testing procedures at any stage in the processing pipeline.

Assays for the BAX® System Q7 include: Salmonella, Genus Listeria, Listeria monocytogenes, Escherichia coli O157:H7, Staphylococcus aureus, Campylobacter coli/jejuni/lari, E. sakazakii (Cronobacter), Vibrio cholerae/parahaemolyticus/vulnificus, yeast and mould and coming soon, BAX® Real-Time STEC screening assay and confirmation panels.

To see for yourself just how simple PCR can be, ask your local Oxoid representative about a free, no obligation, BAX® System trial today (*offer limited to 30 November 2011, terms and conditions apply, quote code OXP1).

Seegene Introduces Anyplex™ II RV16 Detection Assay Ahead of Seasonal Onset for Influenza and Viral Epidemics

Seegene announced the commercialization of its second real-time assay based upon its new TOCE™ technology. The Anyplex™ II RV16 Detection Assay will provide clinicians with a powerful new tool to help prevent the spread of respiratory infections. The Anyplex II RV16 Detection Assay is the only multiplex real-time PCR (polymerase chain reaction) test that can simultaneously detect 16 of the most common respiratory viruses from a wide range of specimen types, such as nasopharyngeal aspirates and swabs, or bronchoalveolar lavage samples. Effective and economical, this Seegene assay sets a new benchmark for rapid respiratory disease screening.

The Anyplex II RV16 Detection assay enables clinicians to simultaneously detect the presence of Influenza A virus, Influenza B virus, Human respiratory syncytial virus A, Human respiratory syncytial virus B, Human adenovirus, Human metapneumo virus, Human coronavirus 229E, Human coronavirus NL63, Human coronavirus OC43, Human parainfluenza virus 1, Human parainfluenza virus 2, Human parainfluenza virus 3, Human parainfluenza virus 4, Human rhinovirus A/B/C, Human enterovirus and Human bocavirus 1/2/3/4.

"Anyplex II RV16 Detection assay gives clinicians an advanced tool for making fast, accurate and cost-effective respiratory diagnoses," said Dr. Jong-Yoon Chun, Chief Executive Officer of Seegene. "The key to controlling influenza epidemics is the time it takes to arrive at an accurate diagnosis. With the Anyplex II RV16 Detection assay we have reduced test turn-around time significantly so that physicians can now make optimal healthcare treatment decisions within hours, positively impacting both the health of the patient and the economics of the healthcare system."

Viruses account for most upper respiratory tract infections, the most common infectious illness in the general population that can elicit a wide range of disease conditions. Infections can be highly variable depending on seasonal conditions with anywhere between 5% and 20% of a population affected during peak epidemics and mini-epidemics.

The diagnostic role of PCR assays for influenza is growing, though their performance for routine clinical use has been limited until now by the turn-around time (TAT) required. The Anyplex II RV16 Detection assay directly addresses this challenge by dramatically reducing TAT to less than 4 hours.

The Anyplex™ II RV16 Detection Assay is based on Seegene's recently introduced TOCE(TM) technology, which turns any real-time PCR instrument into a more powerful multiplexing platform. TOCE enables complex multiplexing in a single fluorescence channel, provides consistent Tm values regardless of the sequence variation of the target, and a level of sensitivity better than that of currently utilized probe-based singleplex real-time PCR assays.

The Anyplex™ II RV16 Detection Assay is currently unavailable in the USA until regulatory clearance.