Thursday, February 28, 2013

Get More From Your Milliflex® System by Combining the Milliflex® Products, Accessories and Services

You can immediately streamline your microbial contamination testing workflow, leverage your quality assurance level by avoiding risks of exogenous contamination and ensure compliance to all GMP/GLP requirements.

Classical Filtration Method

Milliflex Plus Vacuum Pump & Milliflex Filter Units

In pharmaceutical, manufacturing processes, the compact Milliflex® PLUS vacuum pump streamlines filtration steps during testing to accelerate QC sampling Ready-to-use, sterile Milliflex® filter units combine a funnel and a gridded membrane filter in one device. No membrane handling during transfer minimizes the risk of exogenous contamination.

Milliflex filter funnel units can be used in conjunction with either Milliflex® prefilled Agar Cassettes or ready to use liquid media ampoules.


Designed to simplify your workflow, the MilliSnap® plug and play system is a hands-free method for separating your Milliflex funnel and transferring the membrane to the prefilled Milliflex cassettes.

Rinse Fluids

Our rinse fluids provide the highest level of purity and testing confidence and have been formulated and tested to meet the requirements of the United States, European and Japanese Pharmacopoeias. Every rinse solution is validated and packaged in convenient test volumes with aseptically designed screw caps with septum closure for ease of operation to meet all of your sterility and bioburden testing needs.

Rapid Filtration Method with Fluorescence Detection

Milliflex® Quantum
The Milliflex® Quantum system is a rapid fluorescent-based technology designed for fast quantitative detection of microorganisms over a broad range of filterable matrices. The non-destructive method also allows you to identify any microorganisms detected during the initial fluorescent count, using your current ID methodology.

Rapid Filtration Method with ATP Detection

Milliflex Rapid

The Milliflex® Rapid Microbiology Detection and Enumeration system is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples throughout the manufacturing process.

Meet Your Validation & Maintenance Requirements

Merck Millipore offers a complete range of services for our Milliflex platform. Our experts can develop for you a microbiological test method compliant with current regulations. We can also help reduce the time and cost to validate your water testing methodologies. Merck Millipore provides validation protocols and expendables needed for validation as well as rental equipment (rentals in Europe only). We write our comprehensive, ready-to-use Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to the same standards as protocols used to validate pharmaceutical processes. If you need additional support, our experts can perform on-site validation ensuring all test criteria lead to a completely qualified and accurate test method. Maintenance agreements are available to ensure the optimal performance and longevity of your system.

Click here to ask for a FREE process audit of your microbial detection workflow!

Sunday, February 24, 2013

The Biggest Revolution in Microbiology in 50 Years

From the Royal College of Pathologists of Australasia

Medical microbiology is undergoing a revolution explains Dr Jenny Robson and Dr Michael Harrison, microbiology representatives from The Royal College of Pathologists of Australasia (RCPA).  According to Dr Robson, matrix-assisted laser desorption/ionisation-time of flight mass spectrometry (MALDI-TOF MS) is the biggest thing to happen in microbiology laboratories in the past 50 years, offering improved testing and patient care.

"MALDI-TOF MS allows us [microbiologists] to identify bacteria using completely different principles through the analysis of the proteins that a bacterium produces.  MALDI-TOF MS provides rapid organism identification and, in some cases, even susceptibility and resistance testing.  This has the potential to provide quicker results to the clinician, enabling a targeted and timely antibiotic therapy.  Organisms that have, in the past, been difficult to recognise can often be diagnosed much more rapidly.

Initially pioneered in the 1990's, MALDI-TOF MS has only become a reality in the past couple years with many large laboratories in Australia now using this advanced technology.  Dr Robson explains that it has had a very positive impact when testing for those bacterial infections that require a rapid turn-around time, for example Vancomycin Resistant Enterococci (VRE), an increasingly common hospital pathogen that requires rapid infection control precautions to control its spread.

"Over the past 12 months, the introduction of these machines to laboratories for routine diagnostic work has provided a whole new mindset and has made the process more user friendly.  Historically, it took a long time to identify bacteria and yeasts.  Firstly, we had to grow these organisms on agar plates which can take some hours or even days, and then we use identification tests that take a similar length of time.  Now, the diagnosis is almost immediate with the time of the entire process basically changing from as much as five days to less than five minutes," says Dr Robson.

In addition to the improved speed of testing, these tests are relatively inexpensive once the hardware has been purchased and cost a fraction of the tests they have replaced. This may allow more complete characterization of pathogens in a clinical setting. However, Dr Michael Harrison cautions that it is still early days in these new developments. There are still some deficiencies but the databases are improving all the time. Newer applications to directly identify organisms from samples such as blood cultures are also underway.

"Microbiology is a conservative area in terms of technology change.  When looking at colonies, the judgment of an experienced microbiologist is still hugely significant whereas the results of MALDI-TOF MS are purely dependent on the computer database," says Dr Harrison.

Nevertheless, Dr Harrison rates the significance of MALDI-TOF MS in microbiology as equivalent to the invention of the combustion engine.  He explains that young scientists who are new to the field will benefit from this technology.

"For the profession, it also offers vast training opportunities.   As most of our work has been reliant upon the experience of individual microbiologists, in the future, it may be that we won't need to tell young scientists what we think about a sample in order to explain why we think that is the case.  They can put it through the MALDI-TOF MS and see for themselves," says Dr Harrison.

DuPont BAX System Certified by AOAC for Salmonella Detection

A new test for detecting foodborne Salmonella with theDuPont BAX system has been certified as Performance Tested method #081201 by the AOAC Research Institute, DuPont announced. This assay uses powerful polymerase chain reaction (PCR) technology with real-time detection to deliver fast, accurate results.

“We’re very pleased to add this certification to our BAX System line of advanced food diagnostics,” said Doris Engesser-Sudlow, global diagnostics leader, DuPont Nutrition & Health. “Food companies that require certified testing methods can now use this Salmonella assay to help release products faster, saving inventory costs and extending shelf life.”

The AOAC Research Institute – a non-profit, international, scientific organization that administers the Performance Tested Methods program – provides an independent, third-party assessment of proprietary analytical methods to ensure that products perform as claimed.  Validation of this BAX System assay found it to be an effective method for detecting Salmonella in raw ground beef, chicken rinses, cream cheese, bagged lettuce, dry pet food and on stainless steel surfaces.

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 PCR assays, tableted reagents and optimized media to detectSalmonella, Listeria species, Listeria monocytogenes, E. coli O157:H7 and STEC,Campylobacter, Staphylococcus aureus, Vibrio, and yeast and mold.  Many of these tests have been certified by AOAC and AFNOR and/or approved by government agencies in the Americas, Asia and Europe.

Friday, February 22, 2013

EMD Millipore Expands EZ-Product Family

EMD Millipore has announced the addition of three new products to its EZ-product family, designed to facilitate microbial workflow in quality assurance and quality control laboratories, the company said.

The EZ-Product family now includes the EZ-Fluo rapid detection system, a non-destructive, fluorescent staining-based system for microbial detection; the EZ-fit Manifold for contamination-free laboratory filtration; and the EZ-Pak Dispenser Curve for fast, sterile membrane dispensing.

"Increasingly, companies are looking for improved approaches to their quality assurance and quality control programs that are both streamlined and effective," said Frederic Amstoutz, product manager for the BioMonitoring business field of EMD Millipore. "The EZ-Product family provides a complete, integrated solution to streamline microbial workflows, creating a more efficient laboratory, and reducing the risk of contamination."

The EZ-Fluo is better known as the Milliflex Quantum system in the U.S.

Friday, February 15, 2013

UVM Researchers Create Faster Test for Lung Infections

It's not uncommon for people with lung infections and disease to end up in the hospital. Bacteria that interrupts breathing can be dangerous, even fatal. And a diagnosis can take time.

"So usually what we do is we collect sputum from the patients. We ask them to cough up whatever they can cough up and it gets sent to the microbiology lab at the hospital and then time, energy and effort is spent culturing the bacteria and then it takes us a couple of days at least and in the case of tuberculosis, even a couple of weeks before we have information as to whether particular bacteria is going to grow," said Dr. Laurie Leclair, a lung specialist at UVM-FAHC.

But that may change thanks to research at the University of Vermont's College of Medicine and its School of Engineering, where Dr. Jane Hill has developed a breath test that can diagnose lung infections in less than a minute. Just like police can nab a criminal with a fingerprint, doctors may be able to nab bacteria with a breath print.

"It's a collaborative effort between Dr. Hill and myself and it really started out outside of the University of Vermont with people being very interested in a very rapid way to understand what kind of bugs are living in someone's lungs," Leclair said.

In the lab, they're looking at different compounds in the breath, and they've found significant differences between infected and uninfected mice. The next step will be clinical trials at UVM and other academic medical centers, and if effective, doctors call the breath test a breakthrough in detecting disease-causing bacteria.

"I think it has big implications in the intensive care unit where people can get infections while on breathing machines and certainly in the area of tuberculosis and other lung infections as well," Leclair said.

A final answer won't come for another 7-10 years after clinical trials wrap up, but researchers at UVM are optimistic their breath test will mean a faster, easier non-invasive method for diagnosing disease.

The researchers have published their work in the Journal of Breath Research. Here is the full reference and abstract:

Detecting bacterial lung infections: in vivo evaluation of in vitro volatile fingerprints. Jiangjiang Zhu, Heather D Bean, Matthew J Wargo, Laurie W Leclair and Jane E Hill. J. Breath Res. 7 (2013).

The identification of bacteria by their volatilomes is of interest to many scientists and clinicians as it holds the promise of diagnosing infections in situ, particularly lung infections via breath analysis. While there are many studies reporting various bacterial volatile biomarkers or fingerprints using in vitro experiments, it has proven difficult to translate these data to in vivo breath analyses. Therefore, we aimed to create secondary electrospray ionization-mass spectrometry (SESI-MS) pathogen fingerprints directly from the breath of mice with lung infections. In this study we demonstrated that SESI-MS is capable of differentiating infected versus uninfected mice, P. aeruginosa-infected versus S. aureus-infected mice, as well as distinguish between infections caused by P. aeruginosa strains PAO1 versus FRD1, with statistical significance (p < 0.05). In addition, we compared in vitro and in vivo volatiles and observed that only 25–34% of peaks are shared between the in vitro and in vivo SESI-MS fingerprints. To the best of our knowledge, these are the first breath volatiles measured for P. aeruginosa PAO1, FRD1, and S. aureus RN450, and the first comparison of in vivo and in vitro volatile profiles from the same strains using the murine infection model.

Tuesday, February 12, 2013

Southeast Asians to Train on Rapid Identification of Food-Borne Pathogens

Ten researchers and technical staff from government biotech research institutions in Southeast Asia will train on the rapid identification of food-borne pathogens using biotechnological tools at the National Institute of Technology and Evaluation - Biological Resource Center (NBRC) in Chiba, Japan on 12-15 February 2013. The four-day event is co-organized with NBRC by SEARCA and the Asian Consortium for the Conservation and Sustainable Use of Microorganisms (ACM).
The training will involve lectures on food microbiology and food safety, technical information on biotechnological tools for pathogen detection, a hands-on laboratory exercise on various rapid identification test methods, and tours to food testing facilities and factories. Through its Biotechnology Information Center (BIC), SEARCA will sponsor 10 participants from the Southeast Asian region—two participants each from Lao PDR, Thailand, and the Philippines; and one participant each from Cambodia, Myanmar, Indonesia, and Vietnam.
Consuming unsafe food is the cause of many acute and life-long diseases, ranging from diarrheal to various forms of cancer. It was estimated by the World Health Organization that about 2.2 million people succumb to water-borne diarrheal diseases annually. This training hopes to contribute to the food safety capacity of the participating countries through rapid detection of pathogens which is considered the first step for early disease prevention and control of food-borne diseases from microorganisms.
The course is the second joint capacity building activity of SEARCA and ACM. It was preceded by a training course held in Thailand on 23-27 May 2011 on the long-term preservation and management of microbial resources attended by around 70 researchers, lecturers, and PhD students from Southeast Asian countries including Cambodia, Indonesia, Lao PDR, Malaysia, and Myanmar.
The potentials of biotechnology in meeting the challenges to food security and the importance of food safety are recognized by SEARCA as part of its priority areas and the BIC has remained at the forefront in promoting capacity development on biotechnology to various stakeholders in the region.
ACM is a group of public research and government institutions and organizations in Asia which aims “to promote collaboration among government or public organizations in Asian countries for the purposes of enhancing conservation and sustainable use of microbial resources in Asia.” NBRC in Japan promotes basic research and industrial applications through collection and distribution of potentially useful biological resources (microorganisms and cloned genes), and promotes the preservation of microbial resources in its collection.

Micro Imaging Technology Announces Paradigm Shift in Approach to Providing Software-Based Identification of Microbes

Micro Imaging Technology, Inc. (MIT) has developed and patented the MIT 1000, a Microbial Identification System that revolutionizes the pathogenic bacteria diagnostic process and can annually save thousands of lives and tens of millions of dollars in health care costs. This technology, which the Company markets under the name Micro Identification Technologies(R), will identify bacteria in minutes at a significantly lower cost per test compared to conventional methods.
Until recently, MIT's Microbial Identification System, the MIT 1000, was comprised of a hardware detection unit, the MIT 1000 Instrument, and a software-based identification component that ran on a dedicated desktop PC with an installed A/D (analog-to-digital) data collection board. This configuration required a bulky, proprietary ribbon cable connected between the MIT 1000 Instrument and the A/D board in the PC. The identification software used two software components: the User Interface program and customer selected collection of MIT Identifiers(TM). The User Interface program operates the MIT 1000 Instrument and performs microbial identifications using the installed MIT Identifier(TM) collection. The User Interface program implements the identification component, MIT's proprietary algorithms, necessary for successful identification of a given microbial sample. Updates to the User Interface program or the MIT Identifier(TM) collection required manual installation of the new version by the end user.
"Today," says MIT's Chief Scientist, David Haavig, PhD, "MIT has transitioned to a new approach that involves a relatively new trend in the computing world commonly referred to as 'the cloud.' The implementation of MIT's proprietary algorithms and the MIT Identifiers(TM) now resides on high-availability server clusters in geographically disparate data centers." A/D conversion is now performed within the MIT 1000 Instrument and is now connected to a PC via a standard USB cable. Collected data is sent to the identification component via a standard internet connection. This approach allows for protection of MIT's proprietary algorithms and MIT Identifiers(TM) from reverse engineering, use of a very low cost, general-purpose PC for the User Interface program, and, after a simplified initial installation of the User Interface program software by the end user, push installation of updates. This usage model also inherently allows controlled access to MIT's catalog of Identifiers(TM), circumventing the need for updating customers' local software whenever new Identifiers(TM) are added or when the customer chooses to obtain licensing for additional Identifiers(TM). This design allows for the next version of the system to integrate the general-purpose PC functionality into the MIT 1000 system, providing a completely stand-alone design.
Dr. Haavig concluded, "I am excited about the release of this new technology. It provides tremendous simplification of the software upgrade process and allows for hardening of security."
About: Micro Imaging Technology, Inc. Micro Imaging Technology, Inc. is a California-based public company that is also registered to do business under the name Micro Identification Technologies. MIT has developed and patented the MIT-1000, a stand-alone, optically-based, software driven system that can detect pathogenic bacteria and complete an identification test, after culturing, in less than five (5) minutes for pennies per test when compared to any other conventional method. It does not rely on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis. The process requires only clean particle-free water and a sample of the unknown bacteria. Revenues for all rapid testing methods exceed $5 billion annually -- with food safety accounting for over $3.5 billion, which is expected to surpass $4.7 billion by 2015 according to BCC Research. In addition, the recently passed "New" U.S. Food Safety Bill is expected to further accelerate the current annual growth rate of 6.6 percent.

Devices for Detecting Pathogens in Food on the Production Line

CIC microGUNE is developing the PREDETEC project, which aims to produce sensors capable of locating infectious agents in food, thanks to the application of new strategies using ultrasensitive detection.

The food we ingest is one of the paths by which agents capable of producing illnesses are introduced into our organism. Suffice a few examples to understand the repercussion of this type of pathogen: Salmonella is the most prevalent infectious agent in the EU, with more than 40 cases for every 100,000 inhabitants, Campylobacter is the prime cause of diarrhoea in developed countries and Escherichia coli was the cause of the epidemic outbreak which caused 32 deaths in Germany last year and sparked the so-called ‘gherkin crisis’.

Despite greater control, the risks associated with food pathogens are on the increase, and so it is of vital importance to certify that the food that is produced does not contain infectious elements. Precisely with this intention of finding a response to this challenge, the Basque CIC microGUNE cooperative research centre is developing new rapid diagnosis tools aimed at discovering possible pathogens present in food, within the remit of the PREDETEC project.

The objective of the project is to incorporate all the technology necessary to analyse the food sample into a single device and to detect possible pathogens present in situ rapidly and easily. The first results obtained have optimised the research within the remit of other projects financed by the Basque Government with 1.5 million euros. “We are seeking to create a low-cost technology made from disposable materials and that can be applied to food production lines, for example, without the need to transport the sample to a laboratory”, explained Mr. Sergio Arana, one of the lead researchers of the project.

Prototype in 2013

The project is currently at the stage of seeking funding to enable the development of a prototype. It is anticipated that this prototype will be ready by the end of this year (2013), in order to undergo trials in 2014. In accord with programme planning drawn up by the centre, the production stage will be in 2015.

The tools being designed in the PREDETEC project are based on new ultrasensitive detection strategies that have arisen from state-of-the-art diagnosis technologies. Concretely, the techniques being explored at CIC microGUNE are based on, on the one hand, the technique of electrochemical detection incorporated into a Lab-On-a-Chip.

On the other hand, and in a complementary manner, progress is being made in the use of localised surface plasmon resonance, an optical technique based on the study of light transmission through small apertures on a scale of a few hundred nanometres. This novel procedure is capable of discovering very tiny quantities of the element to be detected in the sample.

The combination of the most advanced techniques in biosensorisation, together with microfluidic structures for managing the samples, will give rise to a device capable of detecting the pathogen and typifying it. That is, not only will it identify the presence of Campylobacter in the sample analysed, but will also specify the strain (Campylobacter jejuni, for example).

From amongst the pathogens commonly detected in the food sector, CIC microGUNE has targeted precisely the Campylobacter jejuni strain for their laboratory trials. However, adapting the device to locate other pathogenic strains such as Salmonella or Escherichia coli is envisaged. Moreover, given that the device designed at CIC microGUNE is an open platform, implementing corresponding adaptations could also act to detect viruses. This would give it great use in animal husbandry, providing the possibility of on-the-spot analysis of animal fluids.

Benefits of the device

Achieving greater efficiency in the control of health parameters in foodstuffs is increasingly necessary because, despite controls in the production and distribution stages of the food sector, there are a number of factors giving rise to an increase in the propagation risk of food pathogens.

Amongst these, intensive methods of food production have to be cited, as well as the ongoing growth in industrial food products and which moves the world of commerce, and the increasing distances for transport of food and storage times thereof, together with the increase in human mobility. It should be highlighted that the use of this system, still at the development stage, will have a clear social impact in enhancing food safety, given that it will greatly facilitate locating points of contamination. This advance will also contribute to reducing health costs arising from outbreaks of food poisoning, due to its preventative nature. Thanks to the mentioned capacity of the device to typify the

pathogen, the generation of resistance to antibiotics in the infectious agents will be avoided. “Given that the type of agent infecting the animals in a herd is discovered within a very short space of time and with precision; for example, these animals can be quickly administered the antibiotic specific to combat this infection, and not another”, clarified Mr Jesús Ruano, another of the project’s leading researchers.

The launching of PREDETEC is a clear advance in rapid diagnosis devices, a field in which CIC microGUNE has been working in recent years, having built up a reputation and a proven leadership in large-scale European projects such as Optolabcard, Portfastflu and Labonfoil.

Thursday, February 07, 2013

PathoGenetix Adds Director of Manufacturing and Begins Production of New Rapid Bacterial Strain Typing System

PathoGenetix, Inc., a commercial-stage developer of an automated system for rapid bacterial strain typing, has hired Paul Krassnoff as Director of Manufacturing. Mr. Krassnoff will develop production and quality assurance systems for the manufacture of the company’s proprietary Genome Sequence Scanning™ (GSS™) System.

GSS isolates and analyzes microbial DNA directly from an enriched biological sample—without the need for a cultured isolate—and provides strain typing results in just five hours. GSS combines two breakthrough technologies—automated DNA-preparation and extraction, and high-throughput single molecule scanning—that have broad applicability in industrial diagnostics as well as clinical diagnostics and research. PathoGenetix is developing its first commercial product for use in food safety testing and foodborne disease outbreak investigations.

“We are pleased to have Paul join us in this pivotal role as we move to field testing of GSS this year, and commercial launch of the instrument in 2014,” said PathoGenetix CEO Ann Merrifield. “Paul’s extensive background in diagnostics R&D and manufacturing will be invaluable as PathoGenetix puts its manufacturing, inventory management and QA systems in place.”

Investigating and Preventing Foodborne Disease Outbreaks

According to a new report from the Centers for Disease Control and Prevention (CDC), between 1998 and 2008 there were over 13,000 foodborne disease outbreaks in the U.S. resulting in more than 270,000 reported illnesses. When a pathogen is detected in a food production facility, or is making people sick in a foodborne disease outbreak, an investigation is undertaken to identify the responsible organism and trace it back to its original source. Current identification methods, however, involve complicated and time-consuming protocols that require a week or more to provide the necessary strain information. In the meantime, serious and costly public health and financial implications can mount with each passing day.

Genome Sequence Scanning bacterial strain typing offers unmatched levels of speed and automation for food industry testing and public health outbreak investigations. GSS is an automated system that extracts and analyzes microbial DNA directly from complex samples to confirm and strain type foodborne pathogens. The strain information provided is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen typing in outbreak investigations. The automated platform and simplified protocol require minimal training and ensure consistent, accurate results across laboratories.

“It’s exciting to be part of the launch of the manufactured products for PathoGenetix’s novel diagnostic technology,” Mr. Krassnoff said.

Prior to joining PathoGenetix, Mr. Krassnoff was Sr. Director of Laboratory Operations & Manufacturing at Aushon Biosystems, where he was responsible for the manufacture and quality control of custom multiplexed analytes and the company’s CLIA-certified testing laboratory. With more than 20 years in manufacturing, quality control, project management and R&D in the medical diagnostics industry, Mr. Krassnoff has worked in research ELISA, quality control and OEM operations support at ALPCO Diagnostics, where he was responsible for the successful launch of a new line of 13 products, and in R&D at Genzyme Diagnostics, bioMerieux and Baxter-Dade. Mr. Krassnoff holds a Bachelor of Science in Chemistry from Boston University and a Master of Science in Biomedical Science from Northeastern University in Boston, MA.

About PathoGenetix

PathoGenetix, Inc. (formerly U.S. Genomics, Inc.) is a commercial-stage developer of an automated system for rapid bacterial strain typing from complex samples. Genome Sequence Scanning™ (GSS™) isolates and analyzes DNA directly from an enriched biological sample—without the need for a cultured isolate—and provides results in just five hours, days faster than current methods. Developed under a five-year, $50-million Department of Homeland Security contract to detect bio-threat pathogens in environmental samples, the core GSS technology has broad applicability in food safety, industrial microbiology, and clinical diagnostics and research. PathoGenetix is developing its first commercial product for use in food safety testing and foodborne outbreak investigations, with availability in 2014.

Molecular Detection Inc. Further Strengthens Patent Portfolio Broadly Covering Detection of Antibiotic-Resistant Bacteria

Molecular Detection Inc. (MDI), which develops and markets Detect-Ready® assays designed to increase the speed and accuracy of infectious disease diagnosis, today announced major patent advances in the US and Europe.  A second core US patent has issued covering key aspects of MDI's technology platform that assesses multiple gene targets to accurately distinguish between samples containing antibiotic-sensitive and antibiotic-resistant bacteria.  Additionally, the company has received a notice of acceptance from the European Patent Office for an analogous patent application in Europe.

The US Patent and Trademark Office issued US Patent No. 8362228, "Methods, Compositions and Kits for Detection and Analysis of Antibiotic-Resistant Bacteria," on January 29, 2013.  This is the second US patent in this area awarded to MDI, following on and expanding US Patent No.8,017,337.  The accepted European application (European Patent Application No. 08799821.7) is expected to issue in the coming months.

MDI's Detect-Ready MRSA assay has the unique capability to distinguish between MRSA (methicillin-resistant Staphylococcus aureus), MSSA (methicillin-sensitive S. aureus) and mixed populations of bacteria by amplifying and evaluating multiple gene targets.  MDI has also demonstrated the ability of the Detect-Ready technology to distinguish between antibiotic-sensitive and antibiotic-resistant strains in other bacterial pathogens.  The company is developing a number of assays for these pathogens, such as a test for the early detection of resistant infections associated with sepsis.

"These patent advances in the US and Europe further confirm the advantages of MDI's approach," said Todd Wallach , CEO and chairman of MDI.  "They reinforce the growing body of data showing that our Detect-Ready panel is the most technically advanced screening test available today for MRSA and antibiotic resistance.  We believe that these patents, which include broad method and kit claims, reinforce our leadership position in the molecular detection of antibiotic-resistant and sensitive pathogens, a large and growing healthcare concern worldwide."

An article on antibiotic resistance in the January 24, 2013 edition of the New England Journal of Medicine notes that the recent annual report on global risks from the World Economic Forum concludes that "arguably the greatest risk…to human health comes in the form of antibiotic-resistant bacteria."  Antibiotic-resistant pathogens such as MRSA pose a growing problem to hospitals and healthcare facilities worldwide.  For example, the Centers for Disease Control (CDC) estimates that in 2005, there were approximately 90,000 persons in the US diagnosed with severe MRSA infection and an estimated 19,000 died.

MDI's Detect-Ready MRSA Panel is a qualitative, real-time PCR in vitro diagnostic test that is marketed in the European Union, Australia and Israel and is in late-stage development in the US.  Its CE-mark label has been expanded to include the detection of colonization with MSSA and other bacteria, in addition to MRSA.  Detect-Ready is the only marketed PCR-based MRSA screening test with the proven ability to accurately discriminate between these pathogens, thereby minimizing the potential for false positive results experienced with other MRSA screening tests and providing clinicians and healthcare facilities with the reliable information they need to assess and minimize patient risk.

Detect-Ready kits are compatible with a number of the real time-PCR platforms currently found in most hospitals.  They offer healthcare providers a high-performance sample-to-answer MRSA screening panel with an unmatched combination of accuracy, speed, flexibility and cost-effectiveness.

About Molecular Detection

Molecular Detection Inc. (MDI), a US-based company with offices in Wayne, PA, Tunbridge Wells, UK and Jerusalem, Israel, is developing and commercializing a portfolio of sample-to-answer Detect-Ready® molecular diagnostic tests for the detection of infectious diseases.  The company's first product, a ready-to-use, rapid detection panel for hospital-based MRSA screening, is currently commercially available in the EU and Australia.  MRSA infections represent a growing problem to the healthcare system, and successful MRSA control efforts include the screening of individuals who may be potential carriers to prevent the spread of the disease.  The Detect-Ready MRSA Panel provides increased accuracy, faster time to results and more efficient utilization of hospital resources compared to other MRSA diagnostic products.  MDI's real-time PCR tests are based on novel, patented technologies for differential diagnosis and room-temperature stabilization.

Monday, February 04, 2013

New Independent Validation Study of ProtoCOL 3 System Shows System's Rapid Performance is as Accurate as Manual Colony Counting

Synbiosis, a world-leading manufacturer of automated microbiological systems, is delighted to announce its ProtoCOL 3 rapid automated colony counter has been shown in an independent study to perform with the same level of accuracy as manual colony counting for enumerating 10 different types of microbial colonies on a range of agar plates.

The study, which was performed to GLP-compliant standards at Don Whitley Scientific Contract Microbiology Laboratory, compared the ProtoCOL 3 system with manual counting for enumeration of bacterial, yeast and fungal colonies on either Plate Count Agar, Columbia Blood Agar or Sabouraud Dextrose Agar plates. These plates were surface spread or spiral plated with one of the following organisms: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Kocuria rhizophila, Enterococcus faecalis, Mannheimia haemolytica, Bacillus subtilis, Streptococcus pneumoniae, Candida albicans and Aspergillus brasiliensis. The resulting colonies were then enumerated both manually and using the ProtoCOL 3’s powerful software to produce a count.

For each plate type (spiral and spread) the comparison between ProtoCOL 3 and manual counts were analysed statistically using a t-test. The results (p = 0.105 for spiral plate data and p = 0.143 for spread plate data) did not identify significant differences between manual and the automated counting methods, for either plate type, at the 95% confidence level.

Martin Smith at Synbiosis commented: “The microorganisms in this independent study produce colonies of differing colours, shapes and sizes and were also cultured on both translucent and opaque agars, which means some are a real challenge to count automatically. We’re delighted with the results of this study because they show that there is no significant difference between the accuracy of manual and automated counting with the ProtoCOL 3 in what are realistic evaluation situations you’d see in many microbiology laboratories.”

Martin continued: “Being able to accurately enumerate so many types of colonies on different agars is a task very few automated colony counters can perform well and this study validates the ProtoCOL 3’s versatility for this application. Microbiologists looking to increase their throughput of plate counts can now install a ProtoCOL 3, confident that they will automatically count many different types of bacteria, fungi and yeast in a fraction of the time, while still guaranteeing the accuracy they demand from a manual count.”

Friday, February 01, 2013

Micro Imaging Technology's Eye on the Future

Micro Imaging Technology, Inc. (MIT) has developed and patented the MIT 1000, a Microbial Identification System that revolutionizes the pathogenic bacteria diagnostic process and can annually save thousands of lives and tens of millions of dollars in health care costs. This technology will identify bacteria in minutes at a significantly lower cost per test compared to conventional methods.

Jeffrey Nunez, MIT's Chairman and CEO, stated, "This press release is to provide an update concerning our achievements over the past year and a look ahead for 2013."

We received significant financial backing from our newest Board member, Gregg Newhuis, and others, allowing us to concentrate all of our efforts on moving our technology and marketing strategy forward.

We dramatically improved our balance sheet by reducing the amount of debt accumulated over the past three years -- 2012 shows more than a 65% decrease in liabilities over the previous fiscal year.

We substantially increased our lab capacity and operations, as well as our calculational capacity, over the past nine months which will ultimately allow us to more rapidly increase the number of pathogen identifiers in the MIT 1000 library.

We submitted applications to the Association of Advanced Communities Research Institute (AOAC RI) for Performance Test Method Certification for the MIT 1000 for the identification of the pathogens E. coli and Salmonella.

We invested thousands in production design with our Hawthorne, California-based manufacturing partner, OSI Optoelectronics -- and received our first three commercial, ready-for-sale MIT 1000 systems in November 2012.

We announced in December receipt of U.S. Patent Office approval for our new trademark Micro Identification Technologies® under which we plan to market the MIT 1000. We invested a great deal of time and dollars last year on our new branding -- our new logo, enhanced website and marketing materials.

We also invested a great deal of time, effort and dollars in our intellectual property security and proprietary software technology this past year.

"Have we hit every mark," Nunez asks rhetorically. "Of course not, obviously. We are disappointed that we are not further along in the AOAC certification process on E. coli and Salmonella. But we've done it in proof-of-principle testing so we know it will happen, it's not a matter of if, it's a matter of when. And we're very optimistic that will be this year," he stated. Nunez continued, "Perhaps one of our greatest and most important achievements this past year has been the development of our MIT 1000 software infrastructure. This has significantly improved our ability to maintain and protect sensitive data while simplifying our customers' access to our primary product: our identifiers. This advance ensures that the keys to our technology kingdom remain safely in our hands, securing and safeguarding our proprietary technology."

"Meanwhile," Nunez added, "we haven't been sitting on our hands. We have participated in many relevant trade shows this past year and made numerous valuable contacts in the food safety arena. These contacts have already generated interest from prominent testing laboratories and university research programs interested in collaborative endeavors. Discussions are in the very early formative stages, but we intend to consider every opportunity available to enhance our business and growth strategy. We believe that 2013 is going to be a very exciting year for MIT."

T2 Biosystems Announces Issuance of Patents Covering Components of the T2Dx Direct Detection Device

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the U.S. Patent and Trademark Office has issued two design patents covering components of the T2Dx direct detection device. These patents, USD673,293 and USD674,112, describe cartridge designs for the Company’s T2Candida assay, which is run on the T2Dx platform. T2Candida is a whole blood diagnostic test for the rapid detection of five species of Candida, a fungal pathogen associated with sepsis and the fourth leading hospital acquired infection in the United States.

“The T2Candida assay has the potential to significantly reduce both the high mortality rate associated with Candida infections, as well as the current costs of treating the infection through rapid, species-specific identification,” said John McDonough, President and CEO, T2 Biosystems. “These issued patents build on our intellectual property portfolio for this breakthrough diagnostic assay that uses our T2MR technology, and they support T2 Bio and its partners in the pursuit of a broad range of molecular, immunoassay and hemostasis products.”

T2 Biosystems continues to expand its broad intellectual property position in direct detection diagnostics with the addition of these two new patents. In recent months, T2 Bio has received several new patents that continue to expand and protect the Company’s proprietary assays, consumable components and devices.

About T2 Biosystems

T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR, the Company’s proprietary magnetic biosensor detector. The T2MR technology enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate and rapid assay results. The Company’s products detect molecular, hemostasis or immunoassay targets directly from unpurified clinical samples in hospitals, labs and physicians’ offices.

Neogen Launches ANSR Test Drive Program

Neogen Corporation has launched a new Test Drive program for its ANSR rapid pathogen detection system. This is a limited-time, risk-free 30-day trial for an on-site evaluation of the ANSR system, the firm reports.

“Test Drive is an innovative path that enables prospective customers to easily acquire a new technology for compliance and brand protection without investing in capital equipment,” said Gerry Broski, Neogen’s Director of Food Safety Marketing.  “Test Drive is designed to show prospective, qualified food laboratories how easy rapid pathogen testing can be. ANSR provides results in 10 minutes, post enrichment, which improves efficiencies at the plant, and can be used as a preventive control as described under proposed FSMA guidelines.”

The ANSR Test Drive program gives food testing labs and food companies an opportunity to do on-demand pathogen testing for Salmonella and Listeria spp.  On-demand means that labs no longer have to work around longer PCR run-cycles and wait for 96 samples to be ready. Incorporating an internal control for each assay, ANSR results are DNA definitive as well as rapid, providing a high level of confidence in the results.

A further benefit of the Test Drive is that ANSR is bundled with NeoCare, a premium service program that offers application as well as product support.  The ANSR system’s small footprint and extremely simple workflow make it an easy fit in any laboratory setting.

Update: Rapid DNA Sequencing Used with Clinical Laboratory Tests to Halt MRSA Outbreak in English Hospital

This may be a first for medical laboratory medicine. In England,  researchers used real-time advanced DNA sequencing to contain an infectious disease outbreak at a hospital. Rapid gene sequencing technology allowed them to bring the outbreak to a quick close. This saved other patients from harm and saved money for the hospital.

Clinical laboratory managers will be interested to learn that this ground-breaking episode occurred at Cambridge University Hospitals with the participation of the Wellcome Trust Sanger Institute and the University of Cambridge. Researchers from these institutions used insights gained from DNA sequencing to help stop a potentially deadly outbreak of Methicillin-resistant Staphylococcus Aureus (MRSA) at one of the Cambridge hospitals. The journal The Lancet Infectious Diseases  published the report.

A Step Closer for Clinical Use of Rapid Gene Sequencing by Medical Labs

Whole-genome sequencing was used to validate and expand findings from the hospital’s infection-control team after it had assessed the outbreak through conventional analysis, the research authors wrote in their abstract.

“What we’re working towards is effectively a ‘black box’,” stated clinical microbiologist and professor, Sharon Peacock, Ph.D., of Cambridge’s Departments of Medicine and Pathology. Peacock led the research team. She was quoted in a story published in Cambridge News.

MRSA Outbreak Occurs in Hospital’s Infant Unit

The outbreak of MRSA occurred in the Special Care Baby Unit of Cambridge University’s Rosie Hospital. Three infants tested positive for MRSA within a period of a couple of days, Cambridge News reported. Using insights gained from DNA sequencing, the researchers quickly identified the MRSA bacterial strains from their genomes.

Further, the team identified 12 infants who tested positive for MRSA within a six-month period in 2011. They suspected a link. However, a persistent outbreak could not be confirmed with conventional methods, according to the study authors.

Peacock stated that the MRSA isolated from all the babies were resistant to a nearly identical spectrum of antibiotics. The research team and the hospital epidemiologists tested 154 healthcare workers employed in the baby unit. They discovered one of the workers was a carrier of the MRSA strain that genetically matched the strain found in the infected babies, as well as some members of the greater community.

Reducing the Occurrence of Infectious Disease Outbreaks in Hospitals

The “black box” combines sophisticated DNA profiling and database analysis to produce real time results. Information on the genome sequence goes into the system. The device interprets the data. It then produces a report of the findings, Cambridge News reported. With further development, the researchers hope the device can be designed for routine use by hospital staff whom typically have no training in genetics.

Whole-genome sequencing holds great promise for rapid, accurate, and comprehensive identification of bacterial transmission pathways in hospital and community settings, the study authors wrote in the abstract. In turn, this means reductions in infections, morbidity, and costs.

Peacock elaborated on a number of potential capabilities of the “black box” in the Cambridge News story. These included the ability to:
  • determine the species of the bacterium;
  • determine antibiotic susceptibility;
  • provide information about which genes are present that are often associated with poor outcomes in patients; and,
  • provide information about how related an organism is to other organisms within the same setting, thus giving an indication of the capability of transmission from one patient to another.
The approach is much more accurate than current methods used by pathology laboratories, according to a story on the Cambridge University Hospitals NHS Foundation Trust website.

However, it is still several years away from routine clinical use.

Need Is for Automated Tools That Can Be Used by Clinical Laboratories

“What we need before this can be introduced into routine care is automated tools that interpret sequence data and provide readily understandable information to healthcare workers,” observed Peacock.

For pathologists and clinical laboratory managers, use of rapid gene sequencing as part of a hospital’s infection control effort should be considered a milestone. As has been long predicted, we are steadily approaching that time when next generation gene sequencing technologies will assume an important place in daily clinical use.