Friday, February 24, 2012

OpGen Announces Participation in New European Union Clinical Microbiology Research Consortium

OpGen, Inc., a whole-genome analysis company developing and commercializing a complete suite of break-through products and services based on its proprietary Whole Genome Mapping technology, announced today the company’s participation in the European Union’s Patho-NGen-Trace research program. This multi-year project aims to bring Next Generation Sequencing (NGS) from a specialized basic research method to a standard routine tool for medical and bio-industrial microbiology applications, providing faster pathogen identification with whole sequence genetic characterization. OpGen’s Whole Genome Mapping technology will be used with NGS to generate more accurate sequences of the model pathogens, and to characterize genetic markers for drug-resistance, virulence and whole genome evolution that may not be detected by NGS alone.

Funded by the European Union’s Seventh Framework Programme, the international consortium of leading experts in clinical microbiology will focus on developing NGS combined with Whole Genome Mapping as next generation DNA analysis tools that can be used for the genotyping and diagnosis of pathogens. Three pathogens will serve as models for the development project─Mycobacterium tuberculosis, methicillin-resistant Staphylococcus aureus (MRSA) and Campylobacter species. All three pathogens are found worldwide and pose a serious medical threat and an important challenge when it comes to their treatment.

“We are very pleased to be a part of this international consortium and look forward to advancing the organization’s long-term goal to control, predict and contain the spread of disease,” said Douglas White, chief executive officer of OpGen. “Combining NGS with Whole Genome Mapping will provide powerful new DNA analysis tools to overcome existing obstacles facing microbiologists and scientists and translate into public health and clinical diagnostic applications.”

Continuing advances in sequencing technologies and the decreasing cost of sequencing have resulted in vast amounts of data that must be assembled and analyzed. There is a growing backlog of sequence data resulting from the costly and time consuming bioinformatics and computing required to complete the assemblies and analysis. Transforming this time- and resource-intensive process to a rapid, validated workflow could be adopted for routine use in public health epidemiology and diagnostic workflows.

OpGen’s Whole Genome Mapping technology has been shown to accelerate and streamline the sequence data analysis workflow. This unique and powerful technology rapidly generates high-resolution, ordered, whole genome maps from single DNA molecules. The result is an easy-to-interpret view of the genome that reveals genome architecture in a single image and provides better accuracy for NGS applications.

Thursday, February 23, 2012

GE and InDevR Scientists Developing Breakthrough Device to Improve Diagnosis of Flu at the Point-of-Care

With the peak of flu season upon us, scientists at GE Global Research, the General Electric Company's central technology development arm, have been awarded a program through the Defense Advanced Research Projects Agency (DARPA) to develop a breakthrough medical device that can diagnose the flu and other infectious diseases such as malaria, E. coli and salmonella at the point-of-care. In addition to making an accurate diagnosis, another key goal of the device is to be readily adapted for new strains of diseases so that new diagnostic tests can be rapidly developed.

GE scientists will be partnering with InDevR, a rapidly growing biotechnology company in Boulder, Colorado that develops new tools to assist in disease diagnosis such as the flu and vaccine development as well. GE, with deep research experience in chemistry and world-class experts in DNA and RNA analysis, will be incorporating new materials and molecular biology methods into a device being developed by InDevR. The nearly $5.8 million in funding from DARPA for the project will result in the creation of at least 7 new jobs at InDevR.

Kathy L. Rowlen, PhD, InDevR's CEO and Chief Science Officer, said, "We are thrilled to be working with GE Global Research. The partnership offers a powerful combination of InDevR's strengths in virus identification and instrument development with GE's global leadership in healthcare products, technologies and services. The DARPA contract will not only support innovative research to improve flu diagnosis, it will administer a healthy shot in the arm for Boulder's economy in the form of new, high-paying technology jobs at InDevR."

Erin Finehout, a lead engineer at GE Global Research and principal investigator on the DARPA project, said, "Today, the flu can be diagnosed in the doctor's office, but often patient samples need to be sent out to a lab to confirm a diagnosis and provide more information about a patient's condition. GE and InDevR intend to develop a device that brings this analysis to the point-of-care at the doctor's office, a remote military base, or the site of a humanitarian mission responding to a major health care pandemic."

According to the Centers for Disease Control and Prevention (CDC), as much as 20% of the U.S. population will get the flu during flu season. Of that population, about 200,000 end up being hospitalized for treatment. The hope is that faster, more accurate diagnosis of the flu and other respiratory viruses upfront will lead to improved patient treatment and a reduced number of severe cases.

GE and InDevR scientists are working to develop a device that is highly portable, easy to use and requires little training. This would allow a broader range of medical providers to operate the device and enable it to be used in clinical settings that would reach more people in need of care. DARPA is interested in having a device that could be used in the field to help assess soldiers deployed in remote areas where access to care is limited. This device also is being targeted for use by medics sent out by the U.S. military on humanitarian missions and for disaster relief efforts.

Another key goal for the device is to make it readily adaptable for recognizing new strains of the flu and other infectious diseases. Finehout explained this could be achieved if it can simultaneously analyze multiple types of biomolecules (DNA, RNA, and protein) in a patient sample. Most diagnostic platforms are only designed to work with one of these types of molecules. This versatility will allow for system that not only can be readily modified to recognize new strains, but also diagnose a wide variety of different diseases. This kind of adaptability and versatility is not possible in current devices on the market today.

Wednesday, February 22, 2012

Journal of Clinical Microbiology Publishes Study Demonstrating Accuracy and Specificity of Great Basin Corporation's Staph ID/R Molecular Diagnostic Test

A study published in the March 2012 issue of the Journal of Clinical Microbiology demonstrates that Great Basin Corporation's Staph ID/R rapid, automated DNA multiplex assay can identify major pathogenic strains of Staphylococcus to the species level as well as the presence or absence of the methicillin-resistance determinant gene, mecA. In this study, the assay was 99 percent accurate in comparison to DNA sequencing results.

Staphylococcal infections are one of the leading causes of hospital acquired infections (HAI) worldwide, and up to 60 percent of all staphylococcal infections are methicillin resistant (MRSA). More than 2 million people are diagnosed with an HAI in the U.S. each year, causing approximately 90,000 deaths. Studies have shown that reducing the time to diagnose patients with staphylococcal infections decreases the length of stay at hospitals as well as the rates of morbidity and mortality.

"Great Basin is focused on developing low-cost technology that enables healthcare providers to diagnose patients faster, resulting in better patient outcomes and decreased costs associated with unnecessary tests," said Ryan Ashton, CEO and president, Great Basin Corporation. "The results of this study are particularly encouraging, especially since staphylococcal sepsis infections, such as MRSA, remain an important public health problem that still lack complete information at an appropriate cost."

Researchers from Great Basin Corporation, Denver Health Hospital and the Children's Memorial Hospital in Chicago assessed the sensitivity and specificity of the Staph ID/R test and determined that Staph ID/R has excellent specificity with no non-specific cross-reactivity observed.

"The use of Staph ID/R could positively affect patient management and laboratory workflow," said Robert Jenison, chief technology officer for Great Basin Corporation and lead author of the study. "A significant advantage of the Staph ID/R test is that it can provide species information that may significantly speed up the diagnosis process, ensuring patients get the right treatment sooner. Also, nearly one-third of all positive blood cultures are from contamination and this test can identify these cases to remove patients from costly and unnecessary therapeutic interventions."

Great Basin's highly sensitive, easy-to-use, integrated cartridge system allows for more accurate and information-rich detection of infectious diseases, allowing providers to diagnose and define a clear treatment path sooner for improved patient outcomes, shorter hospital stays and significant cost savings. The company's goal is to deliver assays that can be performed in a CLIA-rated waived or moderately complex laboratory at a lower cost than other molecular diagnostic solutions.

Great Basin's technology entails an integrated disposable cartridge containing all necessary reagents and an inexpensive bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician. The platform has several key advantages over other molecular solutions:
  • Results in less than one hour, depending on the target of interest
  • True sample-to-result with no more than two to three hands-on steps
  • On-demand testing; no batching tests that delay results
  • Multiplexes up to 64 distinct targets in a single assay
In addition to Jenison, the study was authored by Brian Hicke, Chris Pasco, John Dunn, Heidi Jaeckel, Dan Nieuwlandt, and Evelyn Woodruff of Great Basin Corporation; Diane Weed of Denver Health Hospital; and Xiaotian Zheng of Children's Memorial Hospital in Chicago. In November 2011, the company submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its first molecular diagnostic test for Clostridium difficile (C. diff). The company intends to begin clinical trials for the Staph ID/R assay in 2012.

Tuesday, February 21, 2012

Abaxis Announces Launch of Canine Lyme Disease In Office Rapid Test

Abaxis, Inc., a medical products company manufacturing point of care instruments and consumables to the medical, research, and veterinary markets, and reference laboratory services to the veterinary and research markets, announced today the launch of the VetScan Canine Lyme Rapid Test for the detection of Borrelia burgdorferi antibodies in canine blood samples. The test was launched at the Western Veterinary Conference being held in Las Vegas, Nevada February 19-22, 2012. The Canine Lyme Rapid Test is the only single assay rapid test on the market, allowing the veterinarian to offer accurate, flexible and cost-effective Lyme testing options to their clients.

The new Canine Lyme test can be used in conjunction with the quantitative Lyme assay offered at Abaxis Veterinary Reference Laboratories in Olathe, Kansas. If Canine Heartworm testing is also indicated, the Lyme rapid test can be used alongside the VetScan Canine Heartworm Rapid Test or the Canine Wellness Profile that includes a heartworm test, processed by the VetScan VS2 analyzer.

Michael Solomon, Director of Business Development of Abaxis commented "The Abaxis VetScan Lyme Rapid Test is a very sensitive and highly specific lateral flow assay, with positive results often in a matter of minutes, and definitive negative results in only eight minutes."

"The addition of the VetScan Canine Lyme Rapid Test represents an important addition to our rapid test product line. By offering a complete line of accurate, easy to use, flexible, and cost effective products, the veterinarian is able to offer comprehensive and medically appropriate diagnostic services to their clients in clinic. Abaxis will continue to develop and provide these types of diagnostic solutions for the veterinary market." added Martin Mulroy, Vice President of Sales and Marketing for North American Animal Health of Abaxis.

BioControl Systems receives “No Objection” letters for Non-O157 Shiga Toxigenic E. coli (STEC) Test Methods

BioControl Systems, Inc., a worldwide leader in food safety testing announced that it has received “No Objection” letters dated February 3, 2012 from the United States Department of Agriculture Office of Policy and Program Development (USDA OPPD) for its Assurance GDS® test methods for the detection of non-O157 STEC.

Assurance GDS combines the latest advancements in immuno concentration (IMS), molecular technology and food microbiology to provide two new methods for the detection of the major non-O157 serotypes of Shiga Toxigenic E. coli (STEC ) O26, O45, O103, O111, O121, O145 and E. coli O157:H7. A “No Objection letter” was received for both the Assurance GDS Top STEC MPX and Assurance GDS Top 7 STEC (eae) test methods..

The Assurance GDS pathogen detection methods include a proprietary IMS-based sample preparation procedure specifically targeting the top 7 O serogroups followed by PCR analysis for the detection of the eae and stx1 and stx2 genes. This approach satisfies the USDA criteria for detection of STEC. The Assurance GDS methodology targets the STEC genetic sequences contained in the specific serogroups of concern and minimizes false positives from other O serogroups and eliminates the need for additional time consuming and costly analysis. “With Assurance GDS Top STEC MPX, producers can obtain results for both E. coli O157:H7 and the top non-O157 STEC from a single enriched sample and with a single test, after as little as 10 hours of incubation”, explained Anita Kressner, VP Global Sales and Marketing. “Alternately, the Assurance GDS Top 7 STEC (eae) method allows for the sequential analysis of the top non-O157 STEC and E. coli O157:H7 by conducting the IMS sample procedure targeting the top 7 O serogroups, followed by screening first for eae,” states Kressner. If the sample is negative no further testing is required. If positive, the same sample broth is analyzed with the Assurance GDS Top 7 Shiga Toxin genes kit. The test kits to perform both methods are available form BioControl for immediate distribution..

BioControl Systems, Inc. has been a recognized leader in the development of innovative rapid microbiological tests for the food industry since 1985. In addition to non-O157 STEC, the Assurance GDS platform includes assays for E coli O157:H7, Shiga Toxin Genes, Salmonella, Listeria spp., Listeria monocytogenes, Cronobacter and E. coli O104.

Sunday, February 12, 2012

SDIX Announces Collaboration Agreement with BD Diagnostics

SDIX, a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic and food safety applications, and BD Diagnostics, a segment of BD (Becton Dickinson and Company), a leading global medical technology company, today announced the signing of a comprehensive agreement whereby the two companies will collaborate in the development of a microbiology detection solution. The collaboration will combine SDIX’s expertise in development of high performance antibodies with BD’s expertise in diagnostic system development. The collaboration objective is to commercialize a novel system to address market needs for faster time to results and for accurate detection of microorganisms.

Under the agreement, SDIX will provide BD Diagnostics access to its proven antibody technology and a non-exclusive license to its patented bacteria phage technology. BD will pay SDIX a $1.25M upfront fee for a combination of license fees, technology access fees, and paid-for research during system development. In addition to the upfront payment, the agreement provides up to $2.5M in milestone payments and royalties on product sales incorporating SDIX’s patented technology. Upon commercialization of this system SDIX and BD will be engaged in a long term agreement for the supply of antibodies from SDIX to BD.

Francis DiNuzzo, SDIX’s President and CEO commented, “We are excited to be working with a world class organization like BD. This agreement demonstrates our strengths in the design and production of novel, highly specific antibodies and our knowledge and experience in developing antibody based detection systems.” Mr. DiNuzzo went on to say, “The combination of SDIX’s antibodies together with the assay and platform capabilities of BD will enable the partnership to deliver a highly valuable system that we expect to advance microbial detection in many very valuable applications. We are pleased with the opportunity to collaborate with such a capable and well known organization.”

SDIX is a biotechnology company with a core expertise in creating better antigens, better antibodies and better assays for the pharmaceutical, biotechnology and food safety markets. For over 20 years, SDIX has been a leading immune-solutions company, developing results-oriented and innovative antibody-based solutions that enable customers to meet high performance research, diagnostic and commercialization objectives. In the life science market, SDIX’s technology and capabilities are being used to help discover disease mechanisms, facilitate development of new drugs and provide antibodies and assays for the diagnosis of disease. In the food safety market, SDIX continues to expand its footprint as an international supplier of rapid pathogen test technologies that enable more accurate and cost-effective results.

FDA Clears Two STD Tests for the Roche cobas 4800 Diagnostics System

Roche Molecular Diagnostics received FDA clearance for two new tests on its cobas 4800 PCR detection system. The cobas 4800 is a fully automated sample preparation device, which amplifies and detects DNA targets using real-time PCR. The device can run up to 94 tests in 4 hours, enabling rapid analysis of several STD screening tests. 5 different optical channels make it possible to detect multiple targets from one reaction tube. All reagents are easy to load and no thawing or mixing is required. An advanced results algorithm eliminates the need for extra manual curve analysis on the digitally captured data.

The two newly approved tests are used to detect chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self-collected vaginal swabs. The test runs in a multiplex dual probe assay, which means the two targets can be detected in only one sample.

A Human Papilloma Virus (HPV) test already received FDA clearance for the cobas 4800 in April of last year. This test simultaneously provides pooled results on high-risk genotypes like HPV 16 and HPV 18. This makes it possible for laboratories to combine the CT/NG Test and HPV Test onto a single platform.

According to the press release, the registrational trial for the cobas CT/NG test confirmed that self-collected vaginal specimens and male urine specimens provide increased sensitivity and specificity when compared with alternative specimen. The self collection of specimen may help promote the screening compliance for sexually transmitted infections.

Nabsys to Present DNA Sequence Data from Solid-State Nanodetectors

Nabsys, Inc., a life sciences company pioneering development of solid-state single-molecule positional sequencing technology, today announced that data demonstrating the first direct electronic re-sequencing and mapping of DNA will be presented at the annual Advances in Genome Biology and Technology (AGBT) meeting, February 15 to 18, on Marco Island, Fla., and the Omics and Personalized Medicine Conference at the European Molecular Biology Laboratory (EMBL), February 16 to 18, in Heidelberg, Germany.

Nabsys' positional sequencing platform uniquely reveals information about both the identity and location of DNA sequences through direct electrical detection of probes bound to single molecules that may be as large as hundreds of kilobases in length. Depending on how the methodology is deployed, the platform can be used to analyze the full size scale of DNA variation, including single-base resolved sequence, large scale genomic structural variants, chromosomal aneuploidies, and any combination of the above.

"Significant improvements have been made over the past few years in the speed, throughput and cost of generating DNA sequence information, creating great enthusiasm for applying sequencing technology in the clinic," said Barrett Bready, M.D., chief executive officer of Nabsys. "While these advances have been impressive and important, many applications of sequence data - in medicine as well as in basic biological research and agriculture - require similar levels of improvement in data accuracy, information content, reduced data and computational burden, and simplified workflow. The data we are presenting at AGBT and EMBL demonstrate what is possible with purely solid-state detection. These data provide insights into how the Nabsys positional sequencing platform, once scaled, has the potential to set new performance standards and open new markets for DNA sequence analysis."

In contrast to other approaches referred to as "nanopore sequencing," positional sequencing does not attempt to discriminate individual nucleotide bases passing through an electrical detector. Instead, the Nabsys approach involves hybridization of short oligonucleotide probes to very long DNA templates, passage of probe-bound templates through solid-state nanodetectors, and electronic detection of the locations of hybridized probes. By combining information on the positions of many such probes, it is possible to create detailed genomic maps with sparse probe coverage, or true de novo sequences of large genomes with dense probe coverage.

Positional sequencing does not require slowing down DNA translocation rates through nanodetectors. Information can thus be generated very rapidly over unprecedented length scales with a method that is inherently targeted, quantitative, and involves a simple workflow. The use of solid-state nanodetectors provides the basis for a platform that is highly scalable, with the potential for enormous advances in throughput, dramatically reduced data burden, and high volume manufacturing.

Data to be presented will demonstrate that Nabsys' nanodetector design and DNA preparation techniques enable:
  • Analysis of single DNA molecules up to 50kb in length
  • Mapping of probes with precision that greatly exceeds the diffraction limit of light
  • Re-sequencing of targeted regions without a capture or enrichment step
  • Analysis of genome structural variants

Testing Times for TB: Statistics Distinguish

Multivariate statistical data processing has been used to create a model from gas chromatography-mass spectrometry (GC-MS) data of metabolite profiles of the various types of Mycobacterium species tuberculosis (TB). The model could allow diagnosticians and biomedical researchers to quickly and easily distinguish between various infectious Mycobacterium species.

Tuberculosis is relatively rare in the developed world, although there are concerns that pockets of incidence are on the rise in certain poverty-stricken sectors of society, among the homeless, HIV/AIDS patients and drug user communities. Needless to say, there are millions of cases of TB in the developing world and multiple-drug resistant species have recently been reported. TB most commonly attacks the lungs and is spread through coughs and sneezes by those with active infection. Most infections are asymptomatic but about one in ten latent cases progress to active disease and untreated will kill half of those people. The most recent data for 2010 says there were 8.8 million new cases, and 1.45 million deaths. Most cases are seen in sub-Saharan Africa, according to the World Health Organisation.

Current TB detection assays are very sensitive, spotting bacteria at concentrations as low as 10-100 cells per millilitre in the original patient sample. However, the test requires two to six weeks to incubate colonies by which time a patient's infection may have progressed or been passed on to others. Moreover, this so-called gold standard also has a 15-20% rate of false negatives in adults tested. Pre-processing also makes the approach susceptible to 1-4% false positives. There have been many improvements that help overcome these shortfalls but they are expensive systems and require the training of highly skilled staff.

Rapid Response Required

A straightforward, sensitive and rapid test that primarily identify TB easily but also distinguish between potentially lethal and benign Mycobacterium bacteria.

Ilse Olivier and Du Toit Loots of the Centre for Human Metabonomics, at North-West University, in Potchefstroom, South Africa, used a modified Bligh-Dyer extraction procedure to obtain lipid components from Mycobacterium tuberculosis, M. avium, M. bovis, and M. kansasii cultures. They applied principle component analyses (PCA) to the GC-MS data on these extracts.

The team then identified the twelve compounds that best show the variation between the sample groups, suggesting that these might be the preferred metabolite markers for the pathogenic species. PCA and partial least-squares discriminant analysis (PLS-DA) was applied and the metabolite markers used to build a Bayesian statistical classification model to discriminate between the metabolite marker profile of novel samples. Tests of this model correctly identified two blinded samples for each of the Mycobacterium species analysed. The team reports a certainty ranging from 72 to 100% in the Journal of Microbiological Methods.

Sensitive and Speedy

The team adds that the test procedure requires less than 16 hours to carry out and can be used on samples with as low a concentration of bacteria as 1000 cells per millilitre. The smear microscopy test widely used the world over as an alternative to the sophisticated laboratory techniques is much less sensitive at 5000 to 10000 bacteria per millilitre, which means it can only identify between 60 and 70 percent of adult cases from cultured samples.

The new technique is, the team says, the first of its kind to use "a true GC-MS, metabolomics research approach" for the identification of the requisite lipid markers and can be fully automated. The approach has the potential to detect the metabolic markers repeatedly over time. "This study proves the capacity of a GC-MS, metabolomics pattern recognition approach for its use in TB diagnosis and disease characterisation," the researchers conclude.

"We are in the process of testing this method on a variety of other strains of M. avium, M. bovis, M. kansasii and M. tuberculosis, in addition to expanding its capacity to detect other infectious Mycobacterium species simultaneously," Loots explains. "Further validations using larger populations in a typically clinical scenario would probably follow, testing this methods sensitivity and specificity alongside the currently used diagnostic procedures, before various stake holders will be approached to investigate implementation on a larger scale," he adds.

Friday, February 10, 2012

USDA Awards Grant for Food Safety Research

The U.S. Department of Agriculture announced that it has awarded a research grant to the University of Nebraska-Lincoln to help reduce the occurrence and public health risks from Shiga toxin-producing E. coli (STEC) along the entire beef production pathway.

"Shiga toxin-producing E. coli are a serious threat to our food supply and public health, causing more than 265,000 infections each year," said Chavonda Jacobs-Young, acting National Institute of Food and Agriculture director. "As non-O157 STEC bacteria have emerged and evolved, so too must our regulatory policies to protect the public health and ensure the safety of our food supply. This research will help us to understand how these pathogens travel throughout the beef production process and how outbreaks occur, enabling us to find ways to prevent illness and improve the safety of our nation's food supply."

James Keen at UNL, along with a multi-institutional and multi-disciplinary team of researchers, educators and Extension specialists, will use the $25 million grant to improve risk management and assessment of eight strains of STEC in beef. This work will include the O104 strain that caused the recent outbreak in Germany. The project will focus on identifying hazards and assessing exposures that lead to STEC infections in cattle and on developing strategies to detect, characterize and control these pathogens along the beef chain. This knowledge will then be used to find practical and effective STEC risk mitigation strategies. The five main objectives of the project include:

  • Detection: Develop and implement rapid detection technologies for pre-harvest, post-harvest and consumer environments.
  • Biology: Characterize the biological and epidemiological factors that drive outbreaks of STEC in pre-harvest, post-harvest, retail and consumer settings.
  • Interventions: Develop effective and economical interventions to lessen STEC risk from cattle, hides, carcasses, and ground and non-intact beef and compare the feasibility of implementing these interventions for large, small and very small beef producers.
  • Risk analysis and assessment: Develop a risk assessment model for STEC from live cattle to consumption to evaluate mitigation strategies and their expected public health impacts.
  • Risk management and communication: Translate research findings into user-friendly food-safety deliverables for stakeholders, food safety professionals, regulators, educators and consumers.

Most STEC outbreaks are caused by ingestion of contaminated food and contact with fecal material from cattle and other ruminant animals. Most of what is known about STEC comes from outbreak investigations and studies of E. coli O157. The non-O157 STEC strains are not nearly as well understood, partly because outbreaks due to them are rarely identified. This project will help improve our understanding of these strains in addition to O157 strains.

Keen's team includes researchers from the University of Arkansas, University of California-Davis, University of California-Tulare, University of Delaware, Kansas State University, New Mexico State University, North Carolina State University, Texas A&M, Virginia Tech, USDA's Agricultural Research Service and a research consortium comprised of government, academic and industry scientists and food safety professionals. The team will also work collaboratively with several consumer groups, cattlemen groups and meat processor associations, along with numerous industry partners and technology providers, to improve the safety of the beef supply.

Through the President's Food Safety Working Group, USDA and its federal partners have been working on a new, public health-focused approach to food safety based on the principles of prevention, strengthening surveillance and enforcement, and improving response. In September 2011, USDA's Food Safety and Inspection Service announced a proposal to declare six additional serogroups of pathogenic E. coli as adulterants in non-intact raw beef. Under the proposal, if the serogroups O26, O103, O45, O111, O121 and O145 are found in raw ground beef or its precursors, those products will be prohibited from entering commerce. USDA will launch a testing program to detect these dangerous pathogens and prevent them from reaching consumers.

The coordinated agricultural project grant announced today is through USDA's Agriculture and Food Research Initiative (AFRI) and administered through NIFA. AFRI food safety grants promote and enhance the scientific discipline of food safety, with an overall aim of protecting consumers from microbial, chemical, and physical hazards that may occur during all stages of the food chain, from production to consumption.

AFRI is NIFA's flagship competitive grant program and was established under the 2008 Farm Bill. AFRI supports work in six priority areas: plant health and production and plant products; animal health and production and animal products; food safety, nutrition and health; renewable energy, natural resources and environment; agriculture systems and technology; and agriculture economics and rural communities.

BioSpec Global Solutions Completes Program for the New TOG's 9000 for Commercial Market

BS Ltd. announced today that partner BioSpec Global Solutions Inc. has completed the computer programming for its new TOGS 9000.

BioSpec President Don Saunders said, " We now have a fully functional for the computer based TOGS 9000 which will be ready for the commercial retail market within 60 days."

BioSpec Global Solutions Inc. computer program, TOGS 9000, based on TOGS (Time of Growth Spectrophotometer) technique, provides state-of-the-art rapid, simultaneous detection and enumeration of microbiological parameters such as Total Coliform, E.coli., Enterococci and Total Bacteria.

Using globally approved chromogenic/fluorogenic reagent methods it provides automatic detection technique, thus removing any potential human error associated with visual detection process.

The units will be built in the U.S.A. and Canada. The company is currently receiving orders for the TOGS 3000 and 9000 models.

BioSpec Global Solutions Inc., holds world patents on the TOG's 3000 and 9000 machines for rapid, onsite (remote) monitoring of microbial contamination in drinking water, recreational water, agriculture & food, pharmaceuticals and medical applications.

ICBS specializes in mergers and acquisitions (M&A) advisory services and invests in selective businesses with potential for high growth.

A Novel, Reliable and Rapid Method for Detecting, Counting and Identifying Living Bacteria

One of the major challenges in terms of microbiological quality control and public health is to be able to count and identify, both quickly and simultaneously, the bacteria living in an environment.

An innovative and reliable method has recently been developed by a team from the Laboratoire de Chimie Bactérienne of the Institut de Microbiologie de la Méditerranée (CNRS/Aix-Marseille Université) and the Laboratoire de Glycochimie Moléculaire et Macromoléculaire of the Institut de Chimie Moléculaire et des Matériaux d'Orsay (CNRS/Université Paris-Sud). This work is published in Angewandte Chemie on 9 February 2012. A patent covering this method has also been filed.

The technique developed by the team makes it possible to detect living Gram-negative type bacteria, which include pathogens such as Escherichia coli, Salmonella typhimurium and Legionella pneumophila. To do so, the bacteria are placed in contact with KDO, a sugar that bacteria use to synthesize a specific polysaccharide of their cell membrane. However this sugar is modified beforehand through the introduction of an azide function (made up of three atoms of nitrogen). Deceived, the bacteria incorporate the artificial sugar in their membrane. Then, thanks to a fluorescent molecule that attaches exclusively to the azide group, it is possible to identify and count living Gram-negative bacteria, the only ones to have assimilated the modified KDO.

The importance of these results stems from the fact that there is no rapid technique that allows living bacteria of interest to be simultaneously detected and counted. Furthermore, current methods used to count living bacteria are not entirely satisfactory: those requiring to put bacteria in a culture medium are slow (up to several weeks), whereas rapid methods can give false negatives or positives. This new technique combines reliability with rapidity in the detection of living bacteria. Consequently, it could quickly become an indispensable tool in terms of microbiological quality control and public health.

Experiments conducted by the researchers on Gram-negative type bacteria validate this method. In the future, the use of a specific sugar of each bacterium of interest could allow the detection of a very wide range of living pathogenic bacteria.

Thursday, February 09, 2012

Courtagen to Partner with Tetracore in Biodefense Initiative

Courtagen Life Sciences, Inc. ("Courtagen"), a privately held life sciences company that provides innovative proteomic and genomic products and services to the life sciences industry, today announced that it has entered into a strategic collaboration with Tetracore, Inc. ("Tetracore") to develop a next generation biothreat assay for identifying and diagnosing high priority biological agents in clinical and environmental samples. Some of the target agents include those which cause significant diseases such as anthrax and plague, as well as dangerous toxins such as ricin and botulinum. The combined effort will focus on addressing the critical need to quickly and accurately identify the pathogen while also quantifying the magnitude of the potential threat.

The collaboration provides validation of the Courtagen protein diagnostic technology by a recognized leader in diagnostic reagents and assays for infectious diseases and biological warfare threat agents. Together the two companies will pursue a first in class solution that could enable the Biomedical Advanced Research and Development Authority (BARDA) and other Federal biodefense programs to achieve their goal of developing biothreat point-of-care diagnostic countermeasures.

"The unmatched sensitivity, accuracy and ease of use of Courtagen's Avantra® Q400 Protein Biomarker Technology combined with Tetracore's biothreat assay expertise will for the first time enable the creation of rapid diagnostic medical countermeasures in the field," said Brendan McKernan, President of Courtagen Life Sciences. "The outcomes of this partnership have the potential to make a significant impact on biodefense, public health and drug development initiatives."

"This collaboration is a much welcomed opportunity and is on track to produce a powerful solution for point-of-care detection of some of the world's most dangerous agents," said Tom O'Brien, Ph.D., Vice President of Tetracore. "Courtagen's unique multiplex detection technology is an ideal platform to leverage our experience and high quality reagents."

Courtagen has developed a next-generation, POC protein biomarker technology, called the Avantra® Q400 Biomarker Workstation and QPDx® BioChip. This technology is ideal for users who operate in a decentralized environment and require on-demand testing of biomarkers. The protein diagnostics technology provides users with an integrated system that automates sample processing, reagent handling, biomarker detection and analysis. This unmatched simplicity minimizes user error and affords precision with limited operator training.

Tetracore is a biotechnology research and development organization that develops highly innovative diagnostic reagents and assays for infectious diseases and biological warfare (BW) threat agents. The company focuses on antibody-based and nucleic acid-based detection reagents and technologies. Tetracore offers a broad range of highly-specific, rapid, antibody-based test kits and antibody reagents for the detection of BW infectious agents and toxins, including the first FDA-cleared test kit for identification of B. anthracis from colonies. Tetracore also offers a product line of real-time polymerase chain reaction (PCR) test kits for sensitive and specific detection of animal pathogens. In addition, Tetracore contracts with the US Government for development of diagnostic tests for BW agents, novel nucleic acid extraction procedures, and specialized nucleic acid products.

Courtagen Life Sciences is a privately held life science company that provides innovative proteomic and genomic products and services to the Life Sciences industry. Founded by innovators in next-generation sequencing (NGS), genetics, molecular biology, and information science, our company delivers tools that enable researchers and clinicians to make better decisions regarding drug development and patient care. Courtagen provides proteomic and genomic solutions through its various operating divisions.

Tuesday, February 07, 2012

RUSNANO and France's Magnisense to Produce Diagnostic Systems in Russia

RUSNANO and Magnisense today announced that they have finalized details for investment in Magnisense SE, a French developer of the next generation of in vitro bioassays for diagnostic testing in healthcare, veterinary medicine, food safety, and environmental protection. RUSNANO will invest up to €28.5 million over a three-year period in the joint project whose total cost is put at €44.3 million. The remaining co-investment will come from Magnisense's existing and new shareholders.

The new project will manufacture in Russia an advanced diagnostic system based on Magnisense's proprietary technology MIAtek®—a magnetic immunoassay in which nanosized magnetic beads are attached to an antibody that selectively binds target molecules, micro-organisms, or other antibodies in test media. The technology combines the accuracy of laboratory testing with the simplicity and compactness of rapid-test methods to provide rapid and reliable diagnostics for cardiovascular emergencies, HIV and other sexually transmitting diseases, beta-hCG levels, microbiology conditions, and vaccination control to name a few. The magnetic signal is free of interference from environmental factors, permitting more sensitive and reproducible detection than is possible with traditional markers employed in enzymatic and fluorescent technologies.

Magnisense will establish a Russian subsidiary to produce two product lines:

MIAstrip®: point-of-care testing strips that identify a target by detecting known markers for a number of conditions—cardiac arrest, bacterial infections including tetanus, viral infections such as avian flu, and parasitic and fungal infections;
MIAflo®: disposable cartridges that detect and quantify such targets as bacterial contaminants in food (e.g., Listeria and Salmonella) or water (e.g., Legionella).

Magnisense's Russian manufacturing facility is expected to open in 2015 with production capacity of 3.5 million test media. The media will be sold domestically and exported, primarily to Europe, the US, and Japan.

In the future, Magnisense intends to increase production in Russia and to focus on the professional segment of the decentralized diagnostic testing market generally known as point-of-care (POC). It will expand into the CIS, Europe, the US, Japan, and China. POC diagnostics—tests performed in medical environments, the workplace, and at home—have become the driving force in the world's healthcare market. According to Kalorama Information, a market research company specializing in healthcare and related areas, decentralized diagnostics is the fastest growing segment in healthcare. And the professional POC market, already $5.2 billion in 2009, is estimated to be growing at an annual rate of 6 percent with its rate of growth accelerating.

"Transferring this technology to Russia will involve establishing a production facility and an R&D center," said RUSNANO Managing Director Olga Shpichko. "The project will contribute to the array of new diagnostic and treatment methods being developed in the country with RUSNANO's help."

Advantages of MIAtek® technology

Higher quality. The technology is based on magnetic bead markers instead of fluorescent labels or changes in optical density, as is common in enzymatic and fluorescent technologies. This makes the readings independent of transparency or color of the sample and enables direct analysis of blood and other non-homogeneous biological samples. Virtually every magnetic label is counted, providing the highest sensitivity and the most reliable reproduction of results. In comparison with immunoabsorbent assay methods, sensitivity and accuracy are several times greater for such conditions as cardiac arrest.

Easier, faster, simpler. The ability of Magnisense technology to use non-homogeneous test samples such as whole blood reduces time in sample preparation, meaning that results are obtained more quickly, often in as little as 15 to 20 minutes. Moreover, Magnisense testing does not require special medical training or experience. It can be done by a nurse or by the patient himself. The test can be done and its results ready during the patient's office visit and immediately discussed with the doctor. Ease, speed, and simplicity significantly decrease the cost of the procedure and save time for doctors and patients.

Lower cost, more compact. The reader is portable, compact, and low cost. It does not require space or capital expense for a special environment. The physician in solo or group practice could purchase a reader and locate it in his/her office lab.

Wider application. In addition to medical applications, Magnisense is developing tests to monitor the quality of food and air. The company's proprietary technology provides accurate measures of biological targets, singularly or in combination, even in large-volume samples.

Magnisense's reader counts biomarkers

Magnisense's reader counts biomarkers—viruses, bacteria, hormones, enzymes, DNA strands—labeled with superparamagnetic particles in the MIAstrip or MIAflo carrier (grey tube on the right). The results are displayed on a smartphone for analysis in place or wireless transfer.

In the MIAtek® technology, the biomarker being analyzed is labeled with superparamagnetic particles instead of fluorescent and other types of labels used in traditional methods. Magnisense's reader counts magnetic particles with high accuracy without time- and cost-consuming sample processing.

MIAtek technology has the potential to become a leader in the diagnostics segment and to take a major share of the market for in vitro diagnostics worldwide. It will replace technologies used in laboratories today that were developed in the later of the twentieth century. These tests take a long time from sample to result, are costly, and will not comply with future requirements from regulatory authorities.

MIAtek® may also play an important social role. With an aging population, better treatment of chronic illnesses, and governments that are more conscious of the need to reduce healthcare costs, healthcare and related fields will become more and more decentralized. Magnisense has designed its technology—flexible, compact, easy to use, and low cost—to work compatibly with our changing world.

New Rapid Pathogen Test Is User Friendly

In an ideal world, perhaps all of our food would be screened for pathogens before we consume it. But in reality, such testing is expensive and time-consuming for companies.

Most producers do not have the capacity to test for pathogens themselves and must send samples out to a lab. Results can take 2 or more days to process. For companies selling fresh meat or produce with a limited shelf life, this delay can hinder their ability to get product out before it starts to expire.

But a detection technology being developed nanoRETE, a Michigan-based company, in conjunction with Michigan State University, will allow producers to test their products themselves, and to do it in under an hour.

The system, called X-MARK, works by using a pathogen's antibodies to draw it out of a food sample via magnetic pull. These separated particles are then put on a biochip, which is fed into the reader, where an electric current will recognize a pathogen based on the pattern of its electrical current.

"It's simple!" explained Evangelyn Alocilja, who designed the system's nanoparticles, in a phone interview. Alocilja is a professor of biosystems and agricultural engineering at MSU and chief scientific officer of nanoRETE.

For anyone daunted by the mechanics of how the system works, it's practical application is as easy as 1, 2, 3. First, obtain a liquid sample. Juice and milk already qualify. For solid products such as fruit, swish the sample in a bag of distilled water and use the water as your sample. Next, add in the nanoparticle solution, one for each pathogen you want to detect. Finally, put the sample on a biosensor chip and insert it into the reader. Let sit for 40 minutes.

"It's truly field-based," says Alocilja. "It's on-site detection."

X-MARK is not the first detection technology to screen samples in realtime, but it is highly sensitive, detecting as few as 5 to 10 cells per milliliter as opposed to most technologies which have a threshold of 1,000 to 10,000 cells per ml. It's also faster than most products on the market, and is expected to be affordable once it goes public. Production costs for each test are under $1 each.

"The problem right now is that tests are so expensive that producers don't do a lot of testing," says Alocilja.

The system will cut down on testing costs in the short-term, but it could have an even bigger cost-saving impact in the long term by preventing contaminated food from leaving the facility, helping avoid losing thousands and even millions of dollars in a recall or outbreak.

"Not only are there the costs of an outbreak or recall," points out Alocilja, "but there is a negative impact on the brand."

Indeed some recalls and outbreaks result in bankruptcy for the implicated company. This does not mean that X-MARK will be a cure-all for outbreaks. Tests can only screen so many products, and a contaminated product may not be caught if it isn't among the sampled product.

Also, increased testing should not be an indicator that it's okay to slacken food safety controls earlier on in the production process.

"Testing doesn't make it safe. All testing does is tell you that a process is under control," explained Craig Wilson, Costco's Director of Food Safety, in an interview with Food Safety News last year.

The need for rapid, do-it-yourself testing is now greater than ever. As of last year, the U.S. Department of Agriculture has proposed to add 6 more strains of pathogenic E. coli to its list of banned bacteria, meaning that producers could soon be testing ground beef for these bacteria, in addition to the more well-known E. coli O157:H7. For companies who sell fresh meat and must make room to store it during testing, realtime detection is a valuable tool.

The system will also work especially well for fresh produce, says Alecilja. Fresh fruits and vegetables that don't undergo a pathogen-killing step during production or become contaminated post-production are especially dangerous since they will not likely be cooked before eating. Cantaloupes, lettuce, sprouts and tomatoes have all been responsible for multiple serious outbreaks over the past 10 years.

X-MARK technology can also be used to detect other harmful bacteria and toxins, such as tuberculosis and anthrax. For foodborne pathogens, testing can get as specific as the antibody. A more general solution will detect E. coli, whereas a specific one would isolate a specific serotype.

Alecilja says she expects the product to hit markets in about two years.

MIT Submits Application to AOAC for Certification of Test Methods for E. Coli and Salmonella

Micro Imaging Technology, Inc. MMTC -8.51% (otcqb:MMTC) announces the submittal of its applications to the Association of Advanced Communities Research Institute ("AOAC RI") for Performance Test Method Certification for the MIT 1000 System's for accurate bacterial identifications of the pathogens E. coli and Salmonella. In June 2009, MIT announced it was the recipient of the prestigious AOAC RI Certification for the identification of the Listeria bacteria species. Listeria is the bacteria responsible for Listeriosis, a rare but lethal food-borne infection that has a devastating fatality rate of 25 percent. MIT's System, with the two additional pathogenic bacteria identification processes certified, will have the proven capability of identifying over 90 percent of all bacteria causing food related illnesses. The AOAC Report is available from the Company.

The MIT System's identification process is significantly different from all other conventional methods and does not rely on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis -- the process is totally green, requiring only clean water and a sample of the unknown bacteria. Importantly, all test procedures for identifying unknown bacteria are identical and can be performed in minutes by a relatively unskilled operator.

The MIT System's uniqueness and the AOAC RI's extensive evaluation criterion required several months of collaboration to agree on a suitable Test Protocol for the Certification for Listeria. After the Test Protocol was complete, MIT and an independent testing laboratory managed by AOAC performed numerous identification and ruggedness tests to determine the efficacy of the MIT 1000 System. The Test Protocol was designed to: 1) Provide independent provability of the accuracy and repeatability of MIT's test method. After numerous tests, this testing phase showed that the accuracy exceeded 98 percent. 2) Test the System's flexibility if procedures employed by the user are varied from the Company's recommendations. A total of 406 ruggedness tests were performed showing a good tolerance to sensible variations in Company recommend procedures. The preparation of a Final Report in an AOAC RI's format was then submitted to their independent expert reviewers.

David Haavig, PhD and MIT's Chief Scientist, stated, "The AOAC Certification process for E. coli and Salmonella, following this application, should only require three or four months. Since the protocol for making test samples and also the procedure and software for testing using the MIT 1000 are identical to that of Listeria, the time required for AOAC RI to develop the E. coli and Salmonella Certification Test Protocol should be substantially reduced."

"The food industry is our initial targeted market where over $5 billion is spent in rapid ID testing annually and rising in excess of 9 percent per year -- which should accelerate after all the recent food product contamination disclosures and federal legislative actions. Further, it is noteworthy that MIT has demonstrated, without any modifications to testing procedures, the ability to ID, within several minutes and at a cost of pennies per test, over twenty different species of bacteria including the microbes E.coli, Listeria, Salmonella, Staphylococcus aureus, MRSA and other pathogenic bacteria," stated Michael Brennan, MIT's Chairman.

Thursday, February 02, 2012

T2 Biosystems Announces Issuance of Key Patent Providing Broad Intellectual Property Protection for Direct Detection Diagnostic Methods

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the issuance of patent number 8,102,176 by the United States Patent and Trademark Office entitled "NMR Device for Detection of Analytes". The patent broadly covers devices and methods of detecting analytes through magnetic resonance measurement, the basis for T2 Bio's technology. The T2MR technology is capable of directly detecting any immunologic, hemostasis, or molecular target, most recently demonstrated with rapid and accurate direct detection of Candida from whole blood samples.

"The innovative team at T2 Bio is focused on dramatically improving current diagnostic standards across a wide variety of analytes and the '176 patent provides fundamental protection of our T2MR technology," said John McDonough, CEO of T2 Biosystems. "This patent further solidifies our protection of direct detection using the T2MR platform, which is the basis for both our pipeline of diagnostic products and strategic partnerships."

Claims defined within the '176 patent include a method for detection of any analyte or multiple analytes in a single sample through T2MR technology on the T2Dx instrument. The claims further expand the use of the device for magnetic-assisted concentration and subsequent magnetic resonance detection of an analyte.

Wednesday, February 01, 2012

Xagenic Inc. Receives Funding for the Development of On-Demand Molecular Diagnostics

Xagenic Inc., a privately held molecular diagnostics company developing a new technology for decentralized, rapid diagnostic testing, announced the close of a Series A financing totaling $10 million. The financing was co-led by CTI Life Sciences Fund (CTI) and the Ontario Emerging Technologies Fund (OETF) with significant participation by QIAGEN N.V.. The funds will be used to develop a molecular diagnostic testing platform and lead tests designed for use in physician offices, clinics and hospital settings.

Xagenic Inc. is a University of Toronto spinout company based in downtown Toronto. This round of financing builds on a $2.2 million seed round raised in 2010, led by MaRS Innovation.

In conjunction with the closing of this financing, Dr. Shermaine Tilley and Mr. Richard Meadows, both of CTI, will be joining the Board of Directors. Dr. Shana Kelley will remain on the Board and two independent directors will be named shortly.

"We are delighted to have attracted this strong syndicate of investors and look forward to working with them towards establishing Xagenic as a world leader offering rapid, on-demand diagnostic tests that will dramatically improve patient care and lower health care costs", says Dr. Shana Kelley, CTO of Xagenic Inc. "In the past year, Xagenic has achieved a number of key milestones by effectively utilizing our seed financing. The resources provided by this Series A syndicate will allow us to continue to execute our plan of delivering compelling solutions to healthcare's most pressing diagnostic challenges."

"Xagenic's diagnostic testing system, which employs nanotechnology-based microelectrodes, promises to provide a breakthrough, robust solution to point-of-care testing without the need for nucleic acid amplification. We are pleased to co-lead this investment round and provide leadership in building the Company in the future", says Dr. Shermaine Tilley, Partner, CTI.

Idaho Technology, Inc. Seeks FDA Clearance for the Expanded FilmArray® Respiratory Panel

Idaho Technology, Inc. announced that it has filed a submission with the U.S. Food and Drug Administration for 510(k) clearance of five additional respiratory pathogens for its FilmArray Respiratory Panel, a user-friendly Multiplex PCR assay currently FDA cleared for 15 respiratory pathogens. The additional five pathogens are: Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. There are currently no FDA cleared assays for these five pathogens. The Bordetella pertussis outbreaks in recent months have highlighted the need for an FDA cleared test that can rapidly and accurately distinguish viral infections from more serious bacterial illness.

Kirk Ririe, CEO, said, "We have been quite pleased with how well the FilmArray system has been received by the clinical laboratory community and by how quickly it is being adopted. We are very excited about the potential addition of these five respiratory pathogens -- particularly the bacterial targets. Many of our potential and current hospital laboratory customers are eagerly anticipating the launch of the expanded FilmArray Respiratory Panel."

A respiratory tract infection can be caused by one of dozens of viral or bacterial pathogens. While the symptoms caused by these pathogens are nearly indistinguishable, how a healthcare provider chooses to treat a respiratory infection may depend greatly on a rapid and accurate diagnosis of the responsible pathogen. The FilmArray RP is designed to aid healthcare providers in making this diagnosis.

Idaho Technology is currently developing additional applications for its FilmArray system including a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel. The company expects to begin clinical testing its blood culture ID panel later this year.

Roche Receives FDA Clearance for Test to Screen and Diagnose Chlamydia and Gonorrhea Infection in Symptomatic and Asymptomatic Patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs. A polymerase chain reaction (PCR)-based multiplex dual probe assay, the test for chlamydia and gonorrhea offers excellent sensitivity and high specificity and runs on the automated cobas 4800 System, complementing the cobas HPV (Human Papillomavirus)Test that received FDA approval in April.

"This new test will give labs in the U.S. an efficient solution for offering clinicians chlamydia and gonorrhea screening using the preferred specimen types," said Paul Brown, head of Roche Molecular Diagnostics. "Since it received CE mark in 2009, the test has been very well received by labs outside the U.S. and we are pleased to be able to offer it to the U.S. market."

Male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing, according to the summary report from the U.S. Association of Public Health Laboratories and Centers for Disease Control and Prevention. The use of these specimen types is considered a progressive option for CT/NG screening, as they show high sensitivity yet are less invasive and less painful to collect than urethral or endocervical samples and thus may help promote screening compliance. The registrational trial for the cobas CT/NG test also confirmed that self-collected vaginal specimens and male urine specimens provide increased sensitivity and specificity when compared with alternative specimen types across patient populations with both low and high disease prevalence.

"This test will contribute to lowering the burden of disease by providing accurate results from easy to obtain samples - self-collected vaginal swabs from women and first catch urine from males. Allowing patients to be active participants in maintaining their health will encourage screening and facilitate clinic flow," said Dr. Barbara Van der Pol, assistant professor of epidemiology at the Indiana University School of Public Health.

The introduction of the new test expands the menu for the cobas 4800 System and enables laboratories to combine the cobas CT/NG Test and the cobas HPV Test onto a single platform. In addition to the current assays that focus on women's health, Roche is developing tests for the cobas 4800 System menu in the areas of microbiology and oncology.

About the cobas 4800 System and the cobas HPV Test

The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests to meet the needs of the majority of clinical labs.

The cobas HPV Test is the only clinically validated, FDA-approved and CE-marked assay that simultaneously provides pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18. Knowing a woman's status with high-risk HPV genotypes is important as it can provide predictive information about her risk for cervical pre-cancer or cancer.