Saturday, September 28, 2013

New Battelle Aerosol Detection Technology

Detecting and identifying hazardous airborne contaminants is important, but extremely difficult. Building an instrument that can detect and identify both biological and chemical particles in the air is even more difficult. Now try making that sophisticated scientific instrument rugged enough so it can be deployed in challenging and dirty environments, like military air bases or subway platforms. Final challenge: Make it inexpensive, easy to operate, and able to run 24-hours, every day, year-round.

Battelle has met this set of difficult challenges with its patented Resource Effective Bio-Identification System (REBS), which has recently reached some significant, positive milestones.

"We've made dramatic improvements to the current state-of-the-art in hazardous aerosol detection and identification," said Matt Shaw, General Manager of Battelle's CBRNE Defense business. "We've reduced the time it takes to detect and identify a hazardous aerosol, reduced the time to update the system to search for new hazards, and significantly reduced cost -- from purchase price through unit logistics costs."

REBS is a one-of-a kind system that provides rapid and flexible aerosol detection, identification and enumeration capability. The laser-based system continuously monitors the air, looking for dangerous aerosols that pose potential for jeopardizing the safety of people, products or facilities. The system preserves samples for subsequent confirmation, is network-ready, and is able to look for new or different materials within 24 hours of their identification.

The system has been tested over the past several years in various Battelle and government-sponsored tests -- including in Boston's subway. Most recently, a series of successful tests was carried out in which multiple REBS systems demonstrated the ability to rapidly detect and identify airborne biological warfare agents at levels relevant for early warning purposes.

While REBS is primarily designed to be used for military and homeland security applications, potential future uses are being explored in places such as pharmaceutical manufacturing, food safety and hospitals as companies strive to minimize contamination and protect their employees. Four units were recently sold to an international company.

REBS evolved from Battelle's proven biodetection experience and capabilities during the past few decades. Battelle worked on the Army's original Biological Integrated Detection System (BIDS) in the early 1990s, and has been the lead biosuite developer and producer of the Department of Defense's Joint Biological Point Detection System, which now has several hundreds of units deployed around the world.

Friday, September 27, 2013

Roka Bioscience Atlas System For Food Pathogen Detection Integrated At Department of Defense Laboratory

Roka Bioscience announced today the adoption of the Atlas System at the Department of Defense Food Analysis and Diagnostic Laboratory (FADL) at Fort Sam Houston in San Antonio, Texas. The FADL has implemented the Atlas System along with the Atlas Listeria Detection Assay and the Atlas Salmonella Detection Assay, both of which have received AOAC Performance Tested™ certification. The FADL plans to use the Atlas System for high-volume sample testing for Listeria and Salmonella in foods that are provided to all US armed forces around the world.

The Atlas System is an innovative fully automated molecular instrument for the detection of pathogens in food and environmental samples. This instrument utilizes a simple three-step procedure—Enrich, Transfer, Automate—and is capable of processing over 300 samples in 8 hours. The system's continuous workflow and high throughput provides greater efficiency, flexibility, and dynamic scalability to meet the ever-increasing demands placed on food safety laboratories.

The FADL protects the armed forces, ensuring food safety, fitness for consumption, and contractual compliance through microbiological, chemical, and toxicological testing of food and bottled water. The lab also provides technical consultation to the Department of Defense on integrating laboratory testing and food safety into science-based inspection systems.

"We are honored that the Department of Defense has chosen the Atlas System for its food safety testing," said Paul Thomas, CEO and President of Roka Bioscience. "With its high-throughput capabilities, accurate results, and unique technology, the Atlas System is ready for the important task of ensuring the food safety of our US troops domestically and overseas."

Tuesday, September 24, 2013

mariPOC® Rapid Respiratory Tract Diagnostics Now in 16 European Countries

ArcDia International Ltd today announced the expansion of its distributor and service network to cover 18 countries in Europe and Middle-East, twelve of which have been signed during the last four months. mariPOC® is a rapid point-of-care diagnostic test to detect nine pathogens from one nasal swap sample in 20 minutes. mariPOC® respi test is designed for testing upper and lower respiratory tract infections. The test system allows rapid detection and differentiation between viral and bacterial infections.

"We started to work with mariPOC® already in early 2012. The mariPOC® diagnostics platform provides performance, cost-efficiency and usability needed in clinics. Fast results enable better patient care", says Mr. Ferran Prat, Director of Diagnostic unit at Laboratories LETI, distributor of mariPOC® in Spain and Portugal.

"mariPOC® immunodiagnostics performs in practice better than molecular diagnostics that can be too costly and complex to use. Market response has been extremely good, and doctors, nurses and patients like the test better than taking multiple samples or waiting for one or two days for the results", says Jesper Floyd Kristiansen, VP Sales and Marketing at ArcDia Ltd.

About mariPOC®

mariPOC® provides multianalyte diagnostic results for influenza like illnesses and tonsillitis in near patient settings in 20 minutes. The mariPOC® applications are targeted to acute respiratory infections, the most common infectious diseases on Earth. mariPOC® is superior in performance to the conventional test methods, including lateral flow rapid tests and standard bacterial culture. mariPOC® is designed to improve patient management and quality of health care, and it allows timely pathogen-specific diagnostics and medication.

About ArcDia

ArcDia International Ltd is the manufacturer of mariPOC®, world's first multianalyte point-of care diagnostics test for respiratory tract infections. In the future, the company will develop additional point-of-care tests based on its proprietary ArcDia™ TPX detection technology. (Nature Biotech 2000:18). The technology is available for prominent industrial parties for inlicensing. Currently, ArcDia is actively seeking distribution partners for mariPOC®.

Monday, September 23, 2013

Bactest Diagnostic Targeted at Breweries

Cambridge bug-busting technology is being targeted at breweries following a study that showed how effective it could be in removing any risk of bacteria spoiling beer.

Bactest is priming itself for a concerted push in the market following trials of its Speedy Breedy diagnostic device in the brewing sector. CEO, Professor Annie Brooking, told Business Weekly: “We are aiming to sell Speedy Breedy to breweries to help them shave days off the time they have to sit on inventory whilst batches are tested for contamination before it can be shipped.”

Speedy Breedy – a respirometer-based product developed by Bactest – was assessed for its suitability as a rapid microbiology tool for microbial brewing contaminants. Tests were performed with a number of wild yeast species as well as aerobic and anaerobic bacteria.

According to the report, all micro-organisms were successfully detected using the new methodology. Detection time was dependent on type of organism as well as cell concentration in the sample analysed. In most cases Speedy Breedy allowed a more rapid detection than traditional agar plate based methods. This was found to be particularly advantageous for the detection of anaerobic lactic acid bacteria where detection was achieved in under two days (at a concentration of ~2,000 cells/ml) compared to 5-7 days incubation required with traditional agar plate based methods.

Some wild yeast species were also detected very rapidly (11 hours at ~3,000 cells/ml) comparing well with the 3-5 days required for the traditional analysis. Additionally, Speedy Breedy allowed effective rapid detection of low cell concentrations (2-5 bacterial cells/ml in the current tests). The report adds: “The Speedy Breedy staff provided excellent training and technical support. The device was easy to use.”

Bactest recently raised £1.25 million in a round “dominated by business angels.” The technology has been devised and is also manufactured in Cambridge.

Bactest’s ‘Speedy Breedy’ microbial detector is being hailed as the world’s most versatile portable microbial respirometer and is aimed at both research and industrial applications.

Prof Brooking says Speedy Breedy addressed a core market need – to detect the presence and behaviour of microbes in a variety of sample types and applications, quickly, portably and without the need for expensive equipment and specialist people. She said: “Speedy Breedy is a clever little device that will change the way microbiologists, researchers and product safety teams work for good. Speedy Breedy has already received rave reviews and we’re delighted that from today, anyone can buy their own Speedy Breedy in a handful of clicks on the website.”

For product safety, Speedy Breedy enables the rapid detection of microbial contamination without the need to send samples to a lab for testing. It can be used in-situ, even on the production floor, and also provides an audit trail of measurements over time. When connected to a PC, Speedy Breedy enables users to visualise microbial activity in near real time.

Friday, September 20, 2013

A New Rapid Diagnostic Test is Developed for U.S. Porcine Epidemic Diarrhea Virus

An outbreak of Porcine epidemic diarrhea virus (PEDV) first confirmed in the United State May 17, has spread to 17 states and killed thousands of young swine. In response, researchers at the University of Minnesota College of Veterinary Medicine have developed a PEDV rapid diagnostic test. The first-of-its-kind, the test provides a way to quickly identify the presence of domestic PEDV strains.

Although PEDV does not pose a risk to other animals or humans and is no risk to food safety, it kills an average of 50 percent of young swine at newly affected farms. A widespread outbreak could cause significant losses in the pork industry, and at this time there is no known vaccine or treatment for the virus that causes acute diarrhea and vomiting.

Samples from animals suspected of carrying PEDV can be submitted to the University of Minnesota Veterinary Diagnostic Laboratory (VDL) for testing. “Test results are known within 24 hours, allowing for swine producers and farmers to take necessary precautions to prevent further spread. Genetic material is also extracted from the samples, which can be tested and tracked to monitor PEDV spread,” a release from the university says.

According to the university, samples including swine fecal swabs, saliva, serum, feed and fecal, intestinal and lung tissues, can be tested via a multiplex assay which identifies the presence of not just PEDV, but also transmissible gastroenteritis (TEG)—a virus that has existed among U.S. swine populations for some time. Pairing the tests brings the cost to less than $50.

“This is an important new disease that’s entered the U.S. and we have to try to mitigate its damage. The University of Minnesota is working diligently to help address the problem,” James Collins, DVM, PhD, director of the VDL, professor in the College of Veterinary Medicine and expert in food animal diagnostic medicine and infectious disease, says. “Agriculture is such an important part of what we do in Minnesota and thanks to preparation and the help of our partners, we were able to mobilize available resources and technology quickly to turn around a new test in just a few months.

There were 43 reported cases of PEDV in Minnesota as of Sept. 11 according to testing data by the National Animal Health Laboratory Network. Iowa had the most cases with 181.

Novel Test Aims to Detect Viral Infections

Duke University researchers are developing a blood test to more easily tell when a respiratory illness is due to a virus and not a bacterial infection, hoping to cut the dangerous overuse of antibiotics and speed the right diagnosis.

It works by taking a fingerprint of your immune system — how its genes are revving up to fight the bug. That’s very different from how infections are diagnosed today. And if the experimental test pans out, it also promises to help doctors track brand-new threats, like the next flu pandemic or that mysterious MERS virus that has erupted in the Middle East.

That viral “signature could be quite powerful, and may be a game-changer,” said Dr. Geoffrey Ginsburg, Duke’s genomic medicine chief. He leads the team that on Wednesday reported that a study involving 102 people provided early evidence that the test can work.

  • In the most recent experiment, 102 subjects with viral and bacterial infections, as well as healthy control patients, arrived at a hospital emergency room and were given the blood test. With about 90 percent accuracy, the test returned the proper diagnosis in just 12 hours.

Today, when symptoms alone aren’t enough for diagnosis, a doctor’s suspicion guides what tests are performed — tests that work by hunting for evidence of a specific pathogen. Fever and cough? If it’s flu season, you might be tested for the flu virus. An awful sore throat? Chances are you’ll get checked for strep bacteria. A negative test can leave the doctor wondering what germ to check for next, or whether to make a best guess.

Moreover, rapid in-the-office tests aren’t always accurate and can miss infections. So patients may have blood or other samples sent to labs to try to grow any lurking bacteria and tell if it’s to blame, additional testing that can take days.

“This is something we struggle with every day,” said Dr. Octavio Ramilo, infectious disease chief at Nationwide Children’s Hospital in Columbus, Ohio, who wasn’t involved in the new study. Particularly with children, a respiratory virus and a bacterial infection “in the beginning look completely alike,” he added.

Hence researchers at a number of universities are trying to harness a fairly recent discovery: As your immune system detects an invading bug, different genes are activated to fend off a viral infection than to fight a bacterial or fungal one. Those subtle molecular changes appear to be occurring even before you feel any symptoms. And they form distinct patterns of RNA and proteins, what’s called a genomic fingerprint.

The Duke team discovered 30 genes that are switched on in different ways during a viral attack. The test essentially is a freeze-frame to show “what those genes are doing at the moment in time that it’s captured,” explained Duke lead researcher Dr. Aimee Zaas, an infectious disease specialist.

But the virus-or-not question is just the beginning, Ramilo said. His research suggests genomic fingerprints also can distinguish a flu strain from other common viruses.

In larger studies set to begin as early as this flu season, scientists will look at ways of paring down the number of genes the test analyzes and reducing the test's turnaround time to as little as one hour. “We'd love to have the pregnancy test equivalent to viral infections,” Ginsburg said.

Woods, Ginsburg, and others have also filed for a provisional patent on the science behind the test. Their experiment was funded in part by the Defense Advance Research Project Agency (DARPA), an arm of the U.S. Department of Defense.

Many of the infectious samples the team used to develop the test came from the global H1N1 pandemic of 2009. Many H1N1 sufferers were not quickly diagnosed and treated, which allowed the disease to spread to even more individuals.

In addition to the early detection of naturally occurring global pandemics, the authors believe their test could also help the U.S. respond to a bioterrorism attack. “This could help screen people for exposure, perhaps even before they have fully developed symptoms,” Ginsburg said. “We hope it's an application, if it ever comes to that.”

Ginsburg said he expects medical technology companies will follow suit to develop smaller, more readily available diagnostic equipment for rapidly analyzing test samples. “Our hope is it could shut a pandemic down before it gets started,” he said.

The most immediate application, however, will be to curb the overuse of antibiotics. Patients often arrive at the doctor's office with a common cold, which is caused by a virus. Because the symptoms could falsely point to a bacterial infection, antibiotics are often prescribed.

Not only is the treatment futile, it lets bacteria learn to mutate and become more powerful, Ginsburg said, and wastes a patient's time and money.

In a brief statement to Healthline, the CDC said, “CDC welcomes new strategies and technologies that seek to curb unnecessary antibiotic use and resistance.”

Test Rapidly Diagnoses Deadly Burkholderia pseudomallei Tropical Disease

A team of researchers at James Cook University, lead by Associate Professor Patrick Schaeffer, has developed a new highly sensitive and rapid multiplex diagnostic test for melioidosis called ‘2DIA’.

Melioidosis, which particularly affects people in tropical regions of Australia such as Townsville and Darwin, is caused by the multidrug resistant bacterium Burkholderia pseudomallei, which is endemic in Northern Australia and is also listed as a potential bioterror agent.

Melioidosis is difficult to diagnose, which is a contributing factor to the high mortality rate of the disease ranging from 16 per cent in northern Australia to 40 per cent in northeast Thailand.
The development of the new 2DIA diagnostic test involved researchers from JCU and The Townsville Hospital, and was funded by the Queensland Government’s Smart Futures Fund.
Associate Professor Schaeffer, leader of JCU’s Supramolecular and Synthetic Biology Group, said previous sensitive tests took three to four days to obtain a result. Alternative, more rapid tests exist but have very low sensitivity and can misdiagnose of up to half of patients presenting with melioidosis, he said.

“The 2DIA test works by detecting a subset of specific antibodies that are released in the blood of all patients infected by the bacterium,” Associate Professor Schaeffer said.

“The research team is now in the process of translating the technology into a rapid life-saving bedside test.”

Melioidosis is treatable by a limited number of antibiotics and is an important cause of morbidity and mortality in humans and animals in tropical regions. Major risk factors to develop the disease include diabetes mellitus, chronic renal failure, chronic lung disease, and excessive alcohol use.
The findings of this study were recently published in the journal Diagnostic Microbiology and Infectious Diseases.

Reference: Improved diagnosis of melioidosis using a two-dimensional immunoarray, Diagnostic Microbiology & Infectious Disease , Alanna E. Sorenson, Natasha L. Williams, Jodie L. Morris, Natkunam Ketheesan, Robert E. Norton, Patrick M. Schaeffer: DOI information: 10.1016/j.diagmicrobio.2013.07.009.

Tuesday, September 17, 2013

3M Food Safety Launches 48-Hour Yeast and Mold Indicator Test

3M Food Safety announces the global launch of the 3M™ Petrifilm™ Rapid Yeast and Mold Count Plate, an indicator test that enables the detection of yeasts and molds in as little as 48 hours, faster than conventional agar methods. Expanding the 3M Petrifilm Plate technology that has become a worldwide standard for more than 25 years due to its reliability and simplicity, this new plate also offers food processors a simplified solution for inoculation along with an easy, consistent way to interpret and enumerate colonies.

Conventional agar testing methods for yeast and molds require a five to seven day incubation period, the longest waiting time of all microbial quality indicators. By incorporating a new innovative technology, the 3M Petrifilm Rapid Yeast and Mold Count Plate greatly reduces this delay, improving time-to-result, productivity gains, finished goods inventory and product shelf life.
"Yeast and mold indicator testing is extremely important for determining product freshness and quality, but the current testing process is so long that it can hold up a product's release for several days," said Mojdeh Poul, vice president and general manager, 3M Food Safety. "With the 3M Petrifilm Rapid Yeast and Mold Count Plate, we are changing all of that."

The sample-ready system uses an easy three-step process: Inoculation, Incubation and Enumeration. With the reduced incubation time of as little as 48 hours along with the flexibility of incubation at 25°C or 28°C, food processors can benefit from an innovative solution that enables clearer, easier and faster than ever colony enumeration. The 3M Petrifilm Rapid Yeast and Mold Count Plate results in blue-colored yeast and mold colonies and contains technological enhancements that prevent colonies from spreading or overlapping, providing superior interpretation.

"Being able to clearly enumerate the colonies when there are large, overlapping molds was another important customer need we kept hearing about," said Eric Amann, global marketing manager at 3M Food Safety. "Our researchers were able to significantly improve this attribute in addition to providing faster time-to-result with the plate."

The technology has been rigorously tested to perform well on both low and high water activity foods, and will be especially useful for processors of grain, fruit and dairy products where yeast and mold control is particularly important. In addition to foods, the 3M Petrifilm Rapid Yeast and Mold Count Plate can also be used for air, swab or surface contact environmental testing. Food processors can obtain a quantitative assessment of both yeast and molds together, or as a separate count by visually differentiating between the two forms of fungi.

When 3M Petrifilm Plates launched in the mid-1980s, it was widely viewed as a step forward in ensuring the quality and safety of food products. Eliminating the need to prepare, purchase and store agar dishes, they enhance lab productivity and take up 85 percent less space than agar plates, freeing up valuable room in processors' incubators, lab benches and refrigerators, and reducing company waste. Today, 91 of the top 100 U.S. food processing companies rely on 3M for their indicator testing needs.

Thursday, September 12, 2013

Netherlands Researchers Use MALDI-TOF Mass Spec to Identify Bacillus anthracis

Fresh data on Gram-Positive Bacteria are presented in a new report. According to news originating from Rijswijk, Netherlands, by NewsRx correspondents, research stated, "Rapid and reliable identification of Bacillus anthracis spores in suspicious powders is important to mitigate the safety risks and economic burdens associated with such incidents. The aim of this study was to develop and validate a rapid and reliable laboratory-based matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis method for identifying B. anthracis spores in suspicious powder samples."

Our news journalists obtained a quote from the research from Netherlands Organization for Applied Scientific Research, "A reference library containing 22 different Bacillus sp. strains or hoax materials was constructed and coupled with a novel classification algorithm and standardized processing protocol for various powder samples. The method's limit of B. anthracis detection was determined to be 2.5 x 10(6) spores, equivalent to a 55-mu g sample size of the crudest B. anthracis-containing powder discovered during the 2001 Amerithrax incidents. The end-to-end analysis method was able to successfully discriminate among samples containing B. anthracis spores, closely related Bacillus sp. spores, and commonly encountered hoax materials. No false-positive or -negative classifications of B. anthracis spores were observed, even when the analysis method was challenged with a wide range of other bacterial agents. The robustness of the method was demonstrated by analyzing samples (i) at an external facility using a different MALDI-TOF MS instrument, (ii) using an untrained operator, and (iii) using mixtures of Bacillus sp. spores and hoax materials."

According to the news editors, the research concluded: "Taken together, the observed performance of the analysis method developed demonstrates its potential applicability as a rapid, specific, sensitive, robust, and cost-effective laboratory-based analysis tool for resolving incidents involving suspicious powders in less than 30 min."

For more information on this research see: Rapid Identification of Bacillus anthracis Spores in Suspicious Powder Samples by Using Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS). Applied and Environmental Microbiology, 2013;79(17):5372-5383.

Sunday, September 08, 2013

Rapid Diagnostic Tests Decrease Waiting Time for Drug-Resistant TB Patients

Results of a new study suggest that three new diagnostic tests could each be used to successfully diagnose drug resistance in tuberculosis (TB) patients in a quarter of the time taken by the current method.

The research, presented today (8 September 2013) at the European Respiratory Society's Annual Congress in Barcelona, has provided evidence that each test could be used as an effective alternative to standard testing, increasing the possibilities open to clinicians.

Drug susceptibility tests are carried out in people with active TB in order to identify which drugs the TB bacteria are sensitive or resistant to.

It is essential that these are identified as early as possible so that the patient can be provided with the most effective treatment and therefore the most rapid cure, and to prevent the development of even more drug-resistant TB. This is particularly important for patients with extremely-drug-resistant TB (XDR-TB), who may have a short life expectancy if not treated properly.

Traditional methods of drug-susceptibility testing can take anywhere between 21 days to 3 months because a sputum sample must first be collected and cultured.

A new study carried out by researchers in the USA analysed three new tests: pyrosequencing, a DNA sequencing technique; the HAIN line probe test, a commercial test that detects genetic mutations in the bacteria; and the microscopic observation drug susceptibility (MODS), test which screens samples under the microscope.

The researchers investigated the effectiveness of the new tests in over 1,000 patients in India, Moldova and South Africa. They performed the standard drug susceptibility tests, alongside the three new tests and evaluated drug resistance to five drugs: isoniazid, rifampin, moxifloxacin, ofloxacin, amikacin, Capreomycin, and kanamycin.

The results showed that the MODS test took 15 days to complete, the pyrosequencing took 8 days to complete and the line probe assay took 5 days. All three tests produced the same results as the standard testing – 95-98% of the time for almost all the drugs.

Professor Antonino Catanzaro, from the University California, San Diego, said: "Our findings suggest these three tests could provide a quicker way to identify patients who need alternative treatment regimens. This is very important and could potentially save lives as well as help to curb the rise of drug resistant TB. There are benefits and disadvantages to each test. For example, the MODS test, although the slowest of the three new tests we looked at, is much cheaper. It is important to have this range of options available so that TB treatment programmes across the world can assess which method is right for them including consideration of the financial restrictions they work within."

Thursday, September 05, 2013

3M Debuts Food Safety Molecular Detection Assay for Listeria monocytogenes

The new 3M molecular detection assay for Listeria monocytogenes is the fourth test available for the 3M molecular detection system, which provides pure and simple testing for dangerous pathogens in a variety of food matrices.

A breakthrough for the food and beverage industry, the 3M molecular detection assays use isothermal amplification of nucleic acid sequences, plus bioluminescence to detect the amplification. Presumptive positive results are delivered in real-time while negative results are displayed after the assay is completed.

The 3M molecular detection system is an innovative solution that is fast, cost-effective and easy to use, without sacrificing sensitivity or specificity.

Niki Montgomery, global marketing and development manager for 3M Food Safety explains that Listeria monocytogenes is a highly dangerous pathogen that remains a serious concern in the food processing industry.

Introduced to food processors, third-party reference laboratories and other customers in December 2011, the 3M molecular detection system offers a simple and reliable solution for detecting the pathogen through the application of rapid, qualitative technology to enriched food as well as food process samples.

Tuesday, September 03, 2013

Roche's Rapid Mycoplasma Test Receives Acceptance from Canadian Authorities

Roche has announced that the Canadian Health Authority has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products. The test can replace conventional and time-consuming mycoplasma detection assays based on culture methods and was also accepted by the FDA end of last year.

Mycoplasmas are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing. Traditional detection methods, required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture media and in vitro assays to detect contaminating organisms. Requiring as much as 28 days to complete, these growth-based methods are time-consuming, making them laborious and difficult to interpret.

“Mycoplasma contamination represents a significant issue during biological drug production,” commented Ruedi Stoffel, Head of Custom Biotech at Roche. “Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products.”

A lecture about the MycoTOOL test will be offered at the Rapid Microbiological Methods Conference taking place on 11 and 12 December 2013 in Barcelona.

bioMérieux to Acquire Molecular Biology BioFire Diagnostics

bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire BioFire Diagnostics Inc., a privately held U.S.-based company specialized in molecular biology. BioFire invented, manufactures and commercializes its multiplex PCR FilmArray® system, a simple and rapid molecular biology solution dedicated to the diagnosis of infectious diseases. Thanks to its syndromic approach to the diagnosis of these diseases, FilmArray® contributes to improving patient care and reducing healthcare spending. By further stimulating sales of this system and expanding its menu, bioMérieux intends to strengthen the Company's position as a major player in infectious disease diagnostics, its core strategic focus.

Created over 20 years ago, BioFire has developed, produced and marketed a number of automated molecular biology systems, in particular LightCycler®, licensed to Roche Diagnostics. BioFire, which is specialized in PCR* technology, recently developed FilmArray®, a revolutionary system that has introduced a new standard in molecular diagnostics: a syndromic approach to infectious diseases. This new medical approach is based on analyzing a syndrome (i.e. a set of symptoms) and, with a single reagent, identifying the disease-causing organisms responsible for this syndrome, whether they are viruses or bacteria. FilmArray® is a closed system that integrates all molecular diagnostics steps into a single process: sample preparation, amplification, detection and analysis of results. With unmatched user-friendliness, the system makes it easier for hospitals to perform the molecular biology tests available on its menu in the hospital laboratory, increasing the efficiency of diagnostics from both a medical and an economic viewpoint. The company's first commercially launched solution is a respiratory panel** that tests for 20 viruses and bacteria and delivers results in one hour. This respiratory panel is CE-marked and also received FDA clearance for commercialization in the United States. In addition, the sepsis panel was approved by the FDA at the end of June. Other panels are currently under development, including a gastrointestinal panel and meningitis panel.

The two companies present powerful strategic synergies. The FilmArray® system represents a key asset in the development of bioMérieux's franchise in infectious disease diagnostics, its primary area of expertise, which accounts for 85% of sales in clinical applications. On the basis of ongoing R&D, FilmArray® should make it possible to detect over 70 disease agents responsible for respiratory, gastrointestinal and blood infections within the next three years. Thus, FilmArray® is the ideal addition to bioMérieux's differentiated position in molecular biology, which is based on the easyMAG® extraction system and the ARGENE range in particular. BioFire's solutions will furthermore benefit from the extensive and dynamic bioMérieux commercial network, particularly in North America and Europe. In addition, bioMérieux will contribute its capabilities to the automation of reagent production, thereby optimizing manufacturing costs.

"The acquisition of BioFire fits perfectly into bioMérieux's selective strategy for external growth. Following the AES purchase, which strengthened our leadership in industrial applications, the purchase of ARGENE, which showed very strong organic growth of 31% at the end of June 2013, as well as our recently signed partnership with Quanterix in ultrasensitive and multiplex immunoassays, this new acquisition represents a decisive step for our Company. It enables us to reinforce our infectious disease franchise, our main area of specialization. FilmArray® is the only system that makes it possible to detect disease-causing viruses and bacteria using a single reagent. As such, it eliminates the borders between different technologies, simplifying the diagnosis of infectious diseases and delivering faster results for better patient care," said Jean-Luc Belingard, Chairman and Chief Executive Officer of bioMérieux. "On all our markets, we now have a complete portfolio of particularly innovative technologies with two key benefits: enhanced medical value of diagnostics and optimized workflows in medical laboratories. The Salt Lake City BioFire's site will become our hub for our expansion in molecular biology. We are especially pleased to welcome the talented employees of BioFire, who will work in close collaboration with bioMérieux teams at our Grenoble and Verniolle sites."

"We could not have found a better shareholder than bioMérieux, world leader in clinical and industrial microbiology. This is an exciting next step in the evolution of BioFire, and it will allow us to achieve our mission of helping to make the world a healthier and safer place and to continue to support our biodefense customers in the United States Department of Defense and allied forces," said Kirk Ririe, Chief Executive Officer and Founder of BioFire. "bioMérieux's commercial network will further boost sales of our flagship product, FilmArray®. In addition, the Company's unique know-how in the field of infectious diseases will contribute to the development of new panels, creating very attractive prospects for the future."

Novel Molecular Assay for Pre-Surgical Screening Detects Newly Discovered MRSA Strains

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has announced the availability of the CE-marked BD MAX™ StaphSR assay with eXTended Detection Technology in Europe for use on the fully-automated BD MAX™ System. The assay with eXTended detection accurately identifies Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in surgical patients at risk for colonization. This is the only commercially-available molecular assay that detects both the MREJ target that is found only in MRSA and drug-resistance genes: mecA and the recently discovered mecC cassette.[i]

Surgical site infections (SSIs) are the most common healthcare-associated infection in surgical patients.[ii] These infections are associated with increased length of hospitalization of seven to ten days with attributable costs as high as $29,000 per episode.[iii] Patients who develop an SSI have a two-to-eleven fold higher risk of death, compared with surgical patients without an SSI.[iv] Nasal carriage of S. aureus is a well-defined risk factor for subsequent infection in surgical patients. Rapid screening and targeted decolonization decreases SSIs and improves clinical and economic outcomes for surgical patients.

“The rapidly expanding menu on the fully-automated BD MAX™ System provides hospital laboratories a flexible, efficient and cost-effective solution for accurate molecular testing,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems. “The BD MAX™ StaphSR assay can be performed in the same run as MRSA, Clostridium difficile and other assays, enabling laboratories the flexibility to consolidate molecular testing on a single platform to improve overall efficiencies and costs.”

With results available in about two hours compared to two days with culture methods, the BD MAX™ StaphSR assay provides accurate and timely detection of colonized patients. Assays that do not detect mecC strains are prone to false-negative results.[vii]The BD MAX™ StaphSR assay also includes mecA to ensure accurate detection of “dropout” strains that have lost that gene and can remain undetected by other methods.

The BD MAX™ System is the first and only fully-automated, bench-top molecular system designed to perform a broad range of molecular tests. The growing menu of assays includes BD MAX™ MRSA for the detection of MRSA and BD MAX™ Cdiff for the detection of toxigenic Clostridium difficile. Introduction of the BD MAX™ StaphSR assay into the European market represents BD’s commitment to rapidly expand its menu, offering laboratories a broad range of molecular tests that meet both their current and future clinical needs.

[i]Laurent et al., Emerging Infectious Disease 2012;18:1465-1467
[ii]Mangram et al.,. Infect Control Hosp Epidemiol. 1999;20:247-280
[iii]Anderson et al., Infect Control Hosp Epidemiol 2008; 29:S51–S61
[iv]Anderson et al., Infect Control Hosp Epidemiol 2008; 29:S51–S61
[v]Bode et al., N Engl J Med 2010;362:9-17
[vi]Van Rijen et al., PLoS ONE 2012;7(8): e43065
[vii]Garcia-Alvarez et al., Lancet Infect Dis. 2011;11:595-603

ICAAC 2013 to Highlight T2MR® Direct Detection Technology for Sepsis Diagnostics

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that its T2MR® technology will be highlighted through several activities at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, CO, September 10-13, 2013. T2 Bio's presence at ICAAC will focus on T2MR's applications for the rapid and sensitive identification of sepsis pathogens, including its flagship fungal panel, T2Candida®, which can identify species-specific pathogens directly from whole blood in approximately three hours.

Highlights of T2 Biosystems events at ICAAC include poster presentations for rapid species-specific identification of Candida and multiple bacterial species. T2 Biosystems will also host a symposium featuring infectious disease experts discussing the rapid detection of pathogens with the T2MR platform. In addition, T2 Biosystems will co-sponsor a CME credit course and booth exhibition.

Details of T2 Bio events at ICAAC are as follows:

Poster Presentations

Title: T2Candida Assay Shortens the Time to Speciation of Candidemia Compared to Blood Culture
Date: Tuesday, September 10, 2013
Time: 12:00-2:00pm MDT
Session: 023. Clinical Mycology
Abstract Number: M-236
Authors: C. Clancy, P. Pappas, J. Vazquez, K. Garey, G. Thompson and A. Wu

Title: Rapid and Highly Sensitive Direct Detection and Identification of Bacterial Species in Blood Specimens with T2MR
Date: Tuesday, September 10, 2013
Time: 12:00-2:00pm MDT
Session: 013. Detection of Bacteremia
Abstract Number: D-117
Authors: U.H. Thomann, H. Giese, L. Neely, C.W. Rittershaus, T. Lowery


Symposium Title: T2MR Direct Detection of Pathogens in Whole Blood: Rapid, Species-Specific Identification of Candida and Bacterial Infections
Date: Thursday, September 12, 2013
Time: 6:00-8:00pm MDT
Location: Hyatt Regency at the Colorado Convention Center, 650 15th St., Denver, CO
Speakers: Peter Pappas, MD, University of Alabama at Birmingham, Louis Rice, MD, The Warren Alpert Medical School of Brown University, Cornelius Clancy, MD, University of Pittsburgh, and Tom Lowery, PhD, and John McDonough, T2 Biosystems

CME Credit Course

Program Title: Invasive Mycoses: Consider the Source, Consider the Host
Date: Wednesday, September 11, 2013
Time: 5:00-7:00pm MDT
Location: Hyatt Regency Denver at Colorado Convention Center, 650 15th St., Denver, CO
Course Director: Peter G. Pappas, MD, FACP, University of Alabama at Birmingham

Faculty: Barbara D. Alexander, MD, MHS, FIDSA, Duke University School of Medicine, Andrew J. Ullman, MD, FIDSA, Julius Maximilians University Würzburg, and Theoklis Zaoutis, MC, MSCE, University of Pennsylvania Perelman School of Medicine

T2 Bio Exhibition Hall Booth

T2 Biosystems will have its fully-automated bench-top T2Dx instrument, which is capable of running all assay types from sample input to result, on display at booth #801. The exhibition hall is open September 10-12, 2013.

Sunday, September 01, 2013

Cepheid Announces Xpert MTB/RIF Categorized 'Moderate Complexity' by FDA

Cepheid announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert(R) MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene. The test runs on Cepheid's GeneXpert(R) Systems and is the first and only molecular TB (tuberculosis) test to be categorized as Moderately Complex.

"The 'Moderate Complexity' categorization of Xpert MTB/RIF will allow a broad range of healthcare facilities access to actionable results in approximately 2 hours instead of weeks," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "The dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the U.S.(1) Now, U.S. clinicians can leverage those same transformative results not only for the detection of TB (tuberculosis), but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."

Designed for use on Cepheid's GeneXpert Systems, Xpert MTB/RIF not only detects the presence of MTB-complex DNA, but also mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant (MDR-TB). Patients with multidrug-resistant TB need more intensive and prolonged therapy. Xpert MTB/RIF will enable U.S. clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease, not 6 weeks later as is the case with standard laboratory methods.

"Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "About one-third of the human population is infected with TB, but most do not have active disease that requires treatment. Ruling out active disease in TB suspects is a relatively common task of domestic clinical laboratories. We think that the Xpert MTB/RIF test will help to eliminate guesswork and deliver maximum medical value in the management of TB here in the U.S., as already demonstrated abroad."

In the early 1900s TB was the leading cause of death in the United States. Tuberculosis disease and deaths have declined steadily from the early 1900s due largely to the introduction of effective antibiotics and improvements in living conditions. While some improvements in global control of TB have been achieved over the last decade, TB continues to be a leading cause of death from an infectious disease in many countries. In 1993, the World Health Organization (WHO) declared TB a "global health emergency." (2)

 1. Boehme, C. C., et al. (2011). "Feasibility, diagnostic accuracy, and
      effectiveness of decentralised use of the Xpert MTB/RIF test for
      diagnosis of tuberculosis and multidrug resistance: a multicentre
      implementation study." Lancet 377(9776): 1495-1505


BD Supports the FDA’s Proposal to Reclassify Rapid Influenza Tests

BD (Becton, Dickinson and Company), a leading global medical technology company, supports the U.S. Food and Drug Administration's (FDA's) proposed reclassification of rapid influenza detection tests.  A hearing, held on June 13th by FDA's CDRH Microbiology Devices Advisory Committee Meeting, examined the FDA's proposal to reclassify rapid influenza detection tests (RIDTs) currently regulated as Class I devices, into Class II devices.

The recent 2009 flu pandemic has emphasized the poor performance of point-of-care flu tests available at the time. The new performance standards will provide healthcare providers with criteria for evaluating the tests that they use. The proposal would increase performance requirements for RIDTs to attain at least a sensitivity of 90 percent for influenza A and 80 percent for influenza B versus viral culture and/or 80 percent versus polymerase chain reaction (PCR) methods. If these minimum clinical performance criteria are not met, marketed devices will need to be withdrawn from the market one year after the rule is finalized. This proposal culminates years of publications showing that many of the visual read RIDTs had poor sensitivity when compared to viral culture and to reverse transcription PCR methods.

"This proposal is a step in the right direction as physicians and hospitals routinely rely on rapid diagnostic influenza tests to help manage patients that are suspected of having influenza," said Tom Polen, President, BD Diagnostics - Diagnostic Systems. "Raising the standards of rapid influenza tests will provide healthcare providers the right information to guide patient diagnosis and treatment without requiring repeat testing."

BD pioneered the development of a higher performing test platform two years ago with the launch of the BD Veritor™ System Flu A+B test. BD recognized the need for an improved test early and developed and launched the first CLIA-waived flu test referenced to PCR that provides objective results on an easy-to-read digital display.  Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions.

bioMérieux Announces U.S. FDA Clearance for VITEK® MS

bioMérieux announced that it has been granted U.S. FDA 510(k) de novo clearance for VITEK® MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. VITEK® MS is the latest addition to the VITEK® family of products, and it is the first system to enable detection of disease causing microorganisms in minutes: this game-changing technology can significantly improve patient care. The Cleveland Clinic recently named the technique as one of the Top Ten Breakthrough Medical Technologies of 2013.

"bioMérieux has a long history of bringing the most innovative technology to the world of microbiology, so as a world leader in clinical microbiology, we are very proud to be the first to introduce mass spectrometry to U.S. clinical laboratories in 2013, as we celebrate the Company's 50(th) anniversary," said Alexandre Mérieux, Directeur Général Délégué and Vice President, Microbiology Unit. "For half a century, bioMérieux has introduced pioneering diagnostic innovations to the clinical laboratory and VITEK® MS is part of our commitment to transform microbiology diagnostics with innovative solutions providing actionable information for improved medical decisions."

"The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health. "Rapid identification of harmful microorganisms can improve the care of critically ill patients."

To gain FDA clearance bioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates. VITEK® MS accuracy was compared to 16S Ribosomal RNA gene sequencing, the gold standard, for the following categories of microbial pathogens: anaerobic bacteria, Enterobacteriaceae, Gram-positive aerobes, fastidious Gram-negative bacteria, Gram-negative non-Enterobacteriaceae and yeast. The overall accuracy of VITEK® MS compared to nucleic acid sequencing for these organisms was 93.6 percent.

Scientists from these investigation sites praised the new technology and its potential to improve public health:

"In the battle with infectious diseases, time is a luxury we don't have. MALDI-TOF will have one of the greatest impacts on Clinical Microbiology since the use of molecular amplification methods for the identification of pathogens," said Christine C. Ginocchio, Ph.D., M. T. (ASCP), Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System Laboratories and Professor Hofstra North Shore-LIJ School of Medicine. "This technology will revolutionize how we approach traditional microbial identification. Combined with rapid antimicrobial susceptibility testing we can now provide a diagnosis and treatment options within a time frame that will reduce morbidity and mortality."

Researchers from the Washington University School of Medicine decided to put VITEK® MS to a very rigorous test by analyzing a ten-year collection of clinical samples which was initially difficult to identify with traditional methods.

"The question was, if we tested these organisms with MALDI-TOF MS how would we do?" said Dr. Carey-Ann Burnham, Assistant Professor of Pathology and Immunology at Washington University School of Medicine and the Medical Director of Microbiology at Barnes Jewish Hospital. "So, we pulled these samples from the freezer and the answer was very exciting. Nearly all of the isolates were able to be identified with high accuracy in a matter of moments using a single method: MALDI-TOF MS."

"Hackensack University Medical Center remains committed to staying at the forefront of new technology and treatment methods to better care for our patients, and the VITEK® MS is another example of this commitment, " said Robert C. Garrett, president and chief executive officer of Hackensack University Health Network. "We're conducting a study to see what benefits accrue from diagnosing and treating patients with infectious disease faster and more accurately. Mistreatment and antibiotic overuse are major problems in our healthcare system. They cause prolonged suffering and are very costly. We think VITEK® MS, by diagnosing patients faster and allowing for more rapid treatment, should help our bottom line by reducing our expenditures on medication and reducing the length of stay of patients with serious infections."

The VITEK® MS database represents the vast majority of bacterial and fungal infections that afflict humans. As the world leader in clinical microbiology, bioMérieux, holds the largest private strain collection in the world.

For microbiologists who choose mass spectrometry for microbial identification, bioMérieux offers integrated workflow solutions with its VITEK® 2 system to ensure optimal user convenience, full sample traceability and quality of results. All of bioMérieux's systems will be managed with Myla® web-based laboratory informatics solution. The fully integrated system will provide the rich connectivity between identification with VITEK® MS and antibiotic sensitivity testing with VITEK® 2, enhanced information and workflow management.

The following is an FDA press release announcing the 510(k), dated August 14, 2013:

"The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute.

The VITEK MS can identify yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceaefamilies, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. People with immune systems that are compromised or weakened by HIV/AIDS, cancer treatment, or anti-rejection therapy following an organ transplant are particularly vulnerable to these infections.

“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.”

The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry (MALDI-TOF MS). The technology uses a laser to break yeast and bacteria specimens into small particles that form a pattern unique to the microorganism. The VITEK MS automatically compares the microorganism pattern to 193 known yeasts and bacteria in the test system’s database to identify the microorganism.

Compared to other identification methods that require abundant organism growth for testing, mass spectrometry requires only a small amount of yeast or bacterial growth, so testing can start as soon as growth is visible, generally within 18 to 24 hours.  Traditional methods can take up to five days to produce the same identification results.

The FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

For the de novo petition, the FDA based its decision on the results of a study of 7,068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6 percent of the time (with 87.5 percent of microorganisms identified to species level). The VITEK MS provided a `‘no identification’` result for 3.2 percent of the microorganisms in the study. Of all test results, only 0.8 percent were incorrect and 2.4 percent were low discrimination with no correct result.

The VITEK MS is for clinical use for the identification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections."