Meridian Bioscience Receives Canadian Licenses for illumigene(R) Mycoplasma and illumigene(R) Pertussis

Meridian Bioscience, Inc., today announced that it has received medical device license approval from Health Canada to market two additional assays for use on their illumigene(R) molecular diagnostic platform. With the addition of illumigene Mycoplasma and illumigene Pertussis, Meridian continues to expand its position in the Canadian market by providing innovative testing solutions that meet the needs of the clinical laboratory and drive improvements in patient care.

Elena LoCastro, President at Somagen Diagnostics, stated, "Somagen Diagnostics, together with Meridian Bioscience, are excited to announce the launch of the illumigene Mycoplasma and Pertussis diagnostic tests in Canada. These newly released products are uniquely efficient in the detection of the respiratory diseases associated with Mycoplasma pneumoniae and Bordetella pertussis. Canadian healthcare professionals will benefit from the accurate, reliable results with the rapid turn-around time that is generated from illumigene technology. The illumigene Mycoplasma and Pertussis tests are made for use on the illumipro-10(TM) Incubator/Reader and are the first stand-alone Mycoplasma and Pertussis molecular assays licensed by Health Canada. The addition of the illumigene Mycoplasma and Pertussis products to the illumipro-10 test menu offers current illumipro-10 system users within our laboratories the opportunity to further enhance their workflow and efficiencies. In addition, the launch of these new products combined with the existing illumigene test menu, offers an attractive solution for further growth and expansion of our installed system base in Canadian medical laboratories."

Mike Shaughnessy, President of Global Diagnostics at Meridian Bioscience, stated, "We are excited to bring illumigene Mycoplasma and illumigene Pertussis to the Canadian market. These products represent a significant advancement in the improvement of healthcare through better diagnosis and a positive impact in patient outcome. Meridian products offer definitive answers and confident results, thus helping to ensure patients receive the appropriate antibiotic treatment in a timely manner without having to depend on traditional methods which often are impractical for patient management due to the lack of sensitivity and the extended amount of time to result."

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian's diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world.

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3M Molecular Detection Assay for Salmonella Detection Secures Extended Validations

Today, 3M Food Safety announced that its 3M™ Molecular Detection Assay Salmonella has received an extension of the current NF VALIDATION certificate from AFNOR Certification. The extension means that the test kit, which helps food processors and other parties detect Salmonella and consequently prevent salmonellosis, is now validated by the international organization for all human foods and environmental samples.

In a related development, the Salmonella assay’s most recent AOAC INTERNATIONAL Performance Tested MethodSM (PTM) matrix extension and modification has been accepted by AOAC as a First Action Official Method of AnalysisSM (OMA method number 2013.09).

“We are proud that the 3M Molecular Detection Assay Salmonella has now achieved validation for all human foods and environmental products through internationally recognized validation schemes,” said Niki Montgomery, global pathogen detection solutions business manager with 3M Food Safety. “These new validations and extensions approved through these distinguished technical committees, confirm 3M’s molecular approach for pathogen detection.”

AFNOR CERTIFICATION

To achieve NF VALIDATION certification, the 3M Molecular Detection Assay Salmonella went through a comprehensive scientific review process. In December 2012, the assay received NF VALIDATION certification for egg, meat and dairy food products (excluding milk powders), and in February 2013, the AFNOR Certification expert committee found the assay to be as or more effective than standard methods for detecting Salmonella in seafood, vegetable products and environmental samples taken from food processing sites. With this latest NF VALIDATION certification, the 3M Molecular Detection Assay is now certified for the detection of Salmonella in powdered dairy products, cocoa-based products, spices and aromatic herbs, concentrates, instant coffees and teas, using specific protocols for those challenging foods. Following NF VALIDATION rules, the scope of the validation is now all human foods and environmental samples (excluding primary production environmental samples).

AOAC INTERNATIONAL

The Official Methods of Analysis (OMA) is the AOAC INTERNATIONAL’s premier, internationally recognized program for chemical, microbial and molecular biological testing methods. The 3M Molecular Detection Assay Salmonella was validated through the AOAC Research Institute following the harmonized Performance Tested MethodSM (PTM) and Official Methods of Analysis guidelines to receive PTM certification in March 2012 for six matrices and OMA certification in June 2013. In January 2014, a matrix extension/modification of 11 additional foods and three environmental surfaces was added to the assay’s PTM certification, which has now been approved for inclusion in the method’s OMA First Action validation.

The 3M Molecular Detection Assay Salmonella is one of four assays developed by 3M Food Safety for its 3M™ Molecular Detection System. The other assays include, E. coli O157 (including H7), Listeria and Listeria monocytogenes. The 3M Molecular Detection System offers a unique, reliable and rapid qualitative method of pathogen detection and integrates two innovative technologies – isothermal DNA amplification and bioluminescence detection.

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TSI Completes Drug Master File for the BioTrak® Real-Time Viable Particle Counter

TSI Incorporated, the premier provider of particle counting solutions for life science applications, is pleased to announce the submission of a Type V Drug Master File (DMF), with the United States Food & Drug Administration (FDA), for the BioTrak® Real-Time Viable Particle Counter. The BioTrak Particle Counter instantly detects microbial contamination, a vast improvement over century-old culture-based methods.

The DMF submission contains information including technology description, scientific references, test methodologies and results, evaluation guidance, operating information, and validation information (IQ/OQ/PQ). Specialized aerosol microbial testing was conducted and performance validated in accordance with USP <1223> Validation of Alternative Microbial Methods. The DMF contains information supporting the use of the BioTrak detector which is reviewed by the FDA when referenced in manufacturer’s regulatory submittals.

Darrick Niccum, TSI’s Vice President of Marketing stated, “Excellent discussions were held between TSI and the FDA throughout the DMF submittal process. The submission is another step forward for this innovative technology that provides real-time microbial information and helps customers identify root cause of microbial excursions. Ultimately, this enables safer products, helping our customers save money through process improvements.”

Released in 2012, the Biotrak Real-Time Viable Particle Counter is a leading technology in the exciting new field of airborne viable particle detection. Based on 25 years of biological detection experience, the BioTrak Particle Counter utilizes TSI’s field-proven, patented Laser Induced Fluorescence (LIF) technology to determine particle viability. Leveraging multiple channels of fluorescence, the BioTrak Particle Counter provides the best viable discrimination available. It also measures total particles and comes with a collection filter for speciation.

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Quidel Receives FDA Clearance for Herpes Simplex Virus 1+2 and Varicella Zoster Virus PCR Assay

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received clearance, via the De Novo Request process, from the United States Food and Drug Administration (FDA) to market its Lyra(TM) Direct HSV 1+2/VZV multiplex real-time PCR assay. This new molecular test detects and differentiates herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) nucleic acids isolated and purified from swab specimens taken from cutaneous (skin) or mucocutaneous (e.g., mouth, lips, or genitals) lesions on symptomatic patients.

Quidel's latest assay for HSV 1+2/VZV is part of its exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler.(1) The Lyra reagent kits provide attractive features that include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents, as well as other benefits.

Lyra Direct HSV1+2/VZV Assay distinguishes between three pathogenic viruses: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults. The Centers for Disease Control and Prevention (CDC) estimates that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.(2)

The Lyra Direct HSV 1+2/VZV Assay kit includes an extraction-free, three-step sample preparation process that does not require time-consuming automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in approximately 50 minutes.

"We are pleased to receive FDA clearance for our Lyra Direct HSV 1+2/VZV Assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Lyra assay allows us to offer a molecular diagnostic alternative to our widely used cell-based ELVIS assay for the detection and identification of herpes simplex viruses. The inclusion of varicella-zoster virus to the multiplex assay provides the clinician with a rapid and sensitive tool not previously available to aid in the differential diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus in humans."

Quidel also offers FDA-cleared, molecular diagnostic assays under the Lyra brand for the accurate detection of other infectious diseases, such as those caused by Influenza A+B, Respiratory Syncytial Virus, Human Metapneumovirus, Clostridium difficile, and Group A and pyogenic Group C or G Streptococcus.

Quidel's AmpliVue product line offers FDA-cleared, hand-held molecular diagnostic assays for the accurate detection of Clostridium difficile, Group B Streptococcus, and herpes simplex viruses 1 and 2.

The four Lyra and three AmpliVue assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.

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New Research Shows SpecID Metabolomic Fingerprint Technology by Specific Technologies Discriminates Bacterial Strain

Specific Technologies, developer of the SpecID™ technology to rapidly detect and identify bacterial species and strain via a metabolomic fingerprint, today announced results demonstrating strain discrimination of four distinct strains of Methicillin-resistant Staphylococcus aureus (MRSA) comparable to the discrimination obtained via pulsed-field gel electrophoresis.

In the study, titled “Differentiation of Methicillin-resistant Staphylococcus aureus (MRSA) in blood cultures using Colorimetric Sensor Arrays” presented today at the 2014 American Society for Microbiology General Meeting, investigators used the SpecID sensor technology developed by Specific Technologies to “fingerprint” nine distinct clinical isolates of MRSA, comprising four distinct strains. In parallel, investigators characterized the same isolates by pulsed-field gel electrophoresis, the standard method for strain characterization in sophisticated microbiology labs around the developed world. Strain classification trees were built for both methods, with a gel-fragment dendrogram produced for the pulsed-field gel data and a plot in pattern space for the fingerprints of the nine samples produced on the low-cost disposable printed SpecID array.

Results show that strain classification using the SpecID sensor fingerprint technology corresponded to strain characterization produced with electrophoretic gel, but at far lower cost in materials and labor.

“These results showcase an advance in the strain level characterization of blood stream infection,” said Dr. Paul Rhodes, Chief Executive Officer of Specific Technologies. “The low cost and simplicity of the SpecID technology enables its integration into all blood culture bottles, as well as TB or plate culture. This in turn will enable hospitals and government and health agencies to detect and track the spread of hospital-acquired or resistant strains of infection.”

The study was supported in part by a $2.3 million Small Business Innovation Research grant awarded by the National Institute of Allergy and Infectious Diseases toward the development of Specific Technologies’ solution for rapid identification of microorganisms producing blood stream infection.

About the SpecID Technology

During growth in culture bacteria produce small molecule volatile metabolites unique to their species and strain. Specific Technologies has developed the SpecID system, a new paradigm for identifying microorganisms from the metabolomic signature of organism outgas into culture headspace.

Using a chemical fingerprint that combines detection and identification into a simple, automated single step with a low-cost disposable printed sensory array, the SpecID system delivers both detection and species and strain identification results in one simultaneous step, both less expensively and faster than conventional culture methods can register a positive. In a proof-of-principle paper published online in January 2014 in the Journal of Clinical Microbiology researchers demonstrated that the SpecID fingerprint discriminates between highly similar strains of Staphylococcus aureus, indicating that the metabolomic fingerprint is not just species-specific but strain-specific as well. The SpecID system is elegantly simple and reduces cost, time, and labor in the microbiology lab while speeding and automating information flow.

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PathoGenetix Identifies E. coli and Listeria for Food Safety; Enables Identification from Clinical Samples

PathoGenetix™ Inc., a commercial-stage developer of an automated system for rapid bacterial identification, presented new research this week demonstrating the use of its Genome Sequence Scanning™ (GSS™) technology to confirm and strain type pathogenic bacteria. The research shows that GSS could be used to identify foodborne pathogens of increasing concern in food safety, in one study identifying STECs (Shigatoxin-producing E. coli) serotypes with the more dangerous "virulence" genes, and in another study not only differentiating L. monocytogenes among the general Listeria species, but even identifying its strains. The study findings were detailed in two posters presented on Monday at the 2014 General Meeting of the American Society for Microbiology in Boston.

The two posters add to a large body of PathoGenetix and independent research demonstrating the capabilities of the GSS technology in providing rapid, culture independent pathogen subtyping and serotype determination from complex biological samples. The GSS technology, which has broad applicability in food safety, industrial microbiology, and clinical diagnostics and research, will be commercially available in the RESOLUTION™ Microbial Genotyping System by early 2015 for use in food industry safety testing and public health foodborne illness outbreak investigations.

Because the GSS technology scans microbial DNA directly from a mixed culture, and does not require a pure culture isolate, it can identify multiple bacteria serovars or strain types in one sample, and greatly reduce the time, complexity and skill level required to confirm the presence of dangerous pathogens. The level of discrimination provided by GSS is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen typing in public health laboratories. As a result, GSS could be used to enable quicker decisions affecting food safety and public health.

The first study, entitled "Strain typing of BIG 7 STECs and differentiation from stx- and/or eae- BIG 7 serogroup E. coli by Genome Sequence Scanning" demonstrates that GSS could be used to accurately identify particular strains of pathogenic E. coli that have been identified as "adulterants" in food by the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS). Recent USDA-FSIS regulations require food companies to test for the presence of specific disease-causing organisms (E. coli O157:H7 and STECs of six other serogroups) in combination with certain "virulence" genes (stx+ and eae+), which when present indicate the particularly pathogenic nature of the bacteria. This research shows that GSS could be used as a confirmatory method for Big7 STEC screening assays used to test for these adulterants in food products, and reduce potential loss of product due to high false positive rates among current STEC screening tests.

The second study showed that GSS provides similar insights into the structure of the Listeria species, by rapidly confirming and differentiating the pathogenic L. monocytogenes strains from nonpathogenic Listeria species. In the study, entitled "Rapid Molecular Serotyping of Listeria spp. by Genome Sequence Scanning," GSS was used to examine a collection of 18 strains and 35 genome sequences representing five different species of Listeria. In general, the strains from the different species of Listeria were distinctly separated from each other, with strains belonging to the four major lineages of L. monocytogenes forming individual clusters with each serotype clearly distinguished.

In a separate press release, PathoGenetix, has developed and validated a protocol for the identification and subtyping of bacteria directly from human clinical stool samples without prior cultural isolation. The protocol, which runs on the RESOLUTION™ System, enables public health and microbiome research laboratories to determine serotype and strain type information for multiple bacteria directly from an enriched stool sample, in just five hours.

The new protocol also demonstrates the potential use of the System for follow-up identification to the culture independent diagnostic tests (CIDTs) used by hospital and clinical laboratories in diagnosing foodborne diseases. CIDTs screen for multiple pathogens in stool samples without obtaining a pure culture isolate. But identification methods currently used in public health laboratories to determine if the disease-causing organism is part of a larger foodborne outbreak require a cultured isolate. The PathoGenetix protocol has the potential to enable the public health system to do its important work even when CIDTs are employed and no culture is available.

The fully automated RESOLUTION System, including instrument, bioinformatics software and database, and pathogen-specific assays, will be commercially available by early 2015 for use in both food industry testing and public health foodborne illness outbreak investigations.

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Thermo Fisher Scientific to Collaborate with USDA’s Agricultural Research Service and Penn State on Food Safety Testing

Thermo Fisher Scientific, Inc., the world leader in serving science, today announced a new collaboration with the United States Department of Agriculture’s Agricultural Research Service (USDA-ARS) and Pennsylvania State University (Penn State), has been formed to develop rapid methods to detect E. coli in food. The collaboration was undertaken with the aim of providing genetic testing tools to the food industry for purposes of E. coli detection in meat products.

“Molecular technologies for rapid detection, typing, identification, and characterization of pathogens represent a paradigm shift for the food industry,” said Pina M. Fratamico, Ph.D., a research leader with the USDA-ARS. “The current collaboration will lead us to a much higher resolution understanding of E. coli genetics, as well as highly specific and sensitive methods for detecting pathogenic strains, resulting ultimately in a safer food supply.”

Traditionally, the industry has used serological tests, based on detection of surface markers, to type bacterial strains. Analysis of genetic material by DNA technology presents a more comprehensive data set, which allows for the ability to more accurately distinguish closely related strains from one another.

“Consumption of pathogenic E. coli can lead to kidney failure and may be fatal,” said Chobi DebRoy, Ph.D., director of the E. coli Reference Center at Penn State. “Genetic assays that can accurately, rapidly and cost effectively detect pathogenic strains will prevent disease and reduce the economic burden associated with food-borne disease outbreaks.”

The collaboration will take advantage of the extensive collections of E. coli strains housed at USDA-ARS and Penn State, which will be made available to Thermo Fisher scientists for genetic analysis and subsequent development of rapid DNA-based kits for commercial distribution to food testing laboratories. DNA from approximately 200 strains will be sequenced using Thermo Fisher’s Life Technologies Ion Personal Genome Machine (PGM). Commercial tests will be developed on multiple Life Technologies brand platforms, employing either next generation sequencing (NGS) or PCR-based technology.

“Thermo Fisher is uniquely positioned to connect discovery – the characterization of pathogens by DNA sequencing - with commercial test production,” said Ravindra Ramadhar, food safety business director at Thermo Fisher Scientific. “Fast next gen sequencing followed by rapid test development allowed us to play a pivotal role in saving lives during the 2011 E. coli outbreak.”

In July of 2011, Life Technologies’ scientists partnered with University of Munster researchers to sequence the E. coli strain responsible for that summer’s outbreak, which was followed within ten days by shipment of PCR-based kits to European food safety laboratories.

As a first milestone in the collaboration, USDA scientists will submit the DNA sequence information for roughly 58 E. coli strains in GenBank, the public repository of genetic data maintained by the National Institute of Health’s National Center for Biotechnology Information. These 58 strains represent part of a complete data set of approximately 200 total E. coli O-type sequences the USDA-ARS will eventually submit. The complete set will contain the six non-0157 strains for which the USDA proposed testing in its 2011 report Shiga Toxin-Producing Escherichia coli in Certain Raw Beef Products.

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Promising Preliminary Data Show Abbott's Rapid Test May Identify Life-Threatening Infections Faster Than Current Methods

Abbott announced initial results that suggest its innovative testing platform, known as IRIDICA (currently in development), produces results consistent with the current standard of care in just hours. Currently, the diagnosis of serious infections, such as sepsis or pneumonia, can often take several days. The data from the RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study promises to provide new hope for critically ill patients with infections -- and potentially change the way infections are diagnosed around the world.

Principal Investigators for RADICAL retrospectively analyzed samples from more than 180 critically ill patients with suspected severe infections from the United Kingdom, France, Belgium, Poland, Switzerland and Germany, to compare the results of Abbott's technology to culture, the current standard of care. After reviewing the interim data set, independent physicians on an adjudication panel reported they would have prescribed a different course of treatment in more than 50 percent of the cases evaluated.

"Every minute can count when diagnosing and treating serious infections," study author Jean-Louis Vincent, M.D., Ph.D., Professor of Intensive Care, Universite Libre de Bruxelles and the Head of the Department of Intensive Care, Erasme University Hospital, said. "The interim RADICAL results provide increasing evidence that Abbott's platform may be used for critically ill patients with infections to quickly identify microorganisms before lab cultures can detect similar results."

The preliminary study data analysis found the sensitivity of the Abbott technology for blood stream infection and pneumonia assays, which were the primary focus of the study, were 88 percent and 91 percent, respectively, when compared to culture. Just as important, the Abbott technology was able to detect other pathogens that the initial culture missed in many patients. Additionally, the negative predictive values (the probability patients with a negative result do not have an infection) were 98 percent and 97 percent, respectively. This information could enable physicians to more confidently and quickly rule out the source of infection. Although time was not a focus of the study, IRIDICA is being designed to produce results in approximately eight hours versus days.

"Doctors need better tools to diagnose their patients when facing unknown infections, and unfortunately, more than 50 percent of culture tests come back negative, even when infections are believed to exist," said David J. Ecker, Ph.D., divisional vice president, R&D, and general manager for Abbott's Ibis Biosciences business. "The RADICAL results suggest IRIDICA will provide rapid results with the sensitivity of culture, but much earlier, allowing physicians to act quickly and effectively to make life-saving decisions."

The Abbott technology is being designed to identify hundreds of bacteria and candida (fungus) from a direct patient specimen in approximately eight hours. The RADICAL study is expected to be completed in late 2014, and IRIDICA is expected to be available as a CE-marked in vitro diagnostic device in European countries within the next 12 months.

Although this press-release does not specifically identify the technology used, it is assumed that it is the Ibis Biosciences Division PLEX-ID system.

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BD MAX™ Enteric Parasite Panel Achieves CE Mark to Detect Common and Pathogenic Intestinal Parasites

BD Diagnostics, a segment of global medical technology company BD (Becton, Dickinson and Company), announced today the availability of the CE-marked BD MAX™ Enteric Parasite Panel for use with the BD MAX System. The BD MAX Enteric Parasite Panel is the latest panel in the BD MAX Enteric suite for the diagnosis of infectious gastroenteritis.  This panel joins the BD MAX Enteric Bacterial Panel and the Diagenode™ Enteric Viral Panel primers and probes kit that is used with the BD MAX RNA 3 extraction kit to detect gastrointestinal pathogens.  With the availability of the BD MAX Enteric Parasite Panel, the majority of pathogens causing this disease can be detected with a fully automated, rapid and accurate platform.

The BD MAX Enteric Parasite Panel is a qualitative IVD test detecting DNA from Giardia lamblia, Cryptosporidium (C. hominis and C. parvum) and Entamoeba histolytica in stool specimens, both unpreserved and formalin-fixed (10%). These pathogens represent commonly isolated and highly pathogenic organisms.  Results from this assay are available in approximately 4 hours, require minimal technologist time, and may replace traditional methods such as microscopy and immunoassay which can be complex, labor intensive and inaccurate.

"We continue to expand the BD MAX System menu and open system capabilities.  Full automation and standardized workflow will enable laboratories to consolidate a broad range of molecular tests to meet their current and future clinical needs," said Doug White, Vice President and General Manager, Molecular Diagnostics & Women's Health, BD Diagnostics. "BD's suite of enteric assays will allow flexibility for specific testing needs based on patient and clinical presentation, enabling more efficient patient management and laboratory processes."

Globally, there are approximately 1.7 billion cases of diarrhea accounting for more than 2 million deaths annually.  Children less than 5 years of age are particularly at risk with around 760,000 deaths each year. These infections may be caused by viruses, bacteria or parasites and often take two to three days or more to identify in the clinical laboratory using conventional methods.  Infections caused by the parasites Giardia and Cryptosporidia, while relatively common, may be subject to under diagnosis and reporting in Europe.

The BD MAX System offers a highly efficient path to improved clinical outcomes through flexible molecular solutions.  In the laboratory, the BD MAX System automates sample preparation, extraction, amplification and detection on a single system, saving time and improving lab efficiency.  Molecular testing on the BD MAX System is simplified and standardized, eliminating variability in results.  Menu options include both CE marked assays and Open System Reagents that are used for user defined protocols.

In addition to panels detecting enteric parasite, viral and bacterial pathogens, other BD MAX enteric panels are in development for the qualitative detection of additional viral and bacterial pathogens directly from stool specimens in patients with signs and symptoms of gastroenteritis and/or colitis.

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PositiveID Corporation Signs Space Act Agreement With NASA

PositiveID Corporation, a developer of biological detection and diagnostics solutions, announced today that it has signed a Space Act Agreement with NASA's Ames Research Center to collaborate on testing the Company's Firefly Dx detection system ("Firefly") as a platform for biological research and commercial development for ground and space applications.

PositiveID's Firefly Dx is a point-of-need, handheld system designed to deliver molecular diagnostic results using real-time TaqMan® PCR (polymerase chain reaction) chemistry. Firefly is intended to derive results from a sample in less than 20 minutes at the point of need, compared to two to four hours for a lab device. Quicker, accurate diagnostics derived from Firefly may lead to more rapid and effective treatment than what is currently available with existing systems. Firefly is being developed to meet the growing need for more rapid and accurate point-of-need diagnostics that will enable hospitals, first responders, and other providers to save lives.

Under this Space Act Agreement, NASA will assess the Company's Firefly Dx technology for potential ground and space applications, while PositiveID will assess the technology to improve its development of the Firefly Dx hardware for extreme environments, such as Department of Defense field applications.

William J. Caragol, Chairman and CEO of PositiveID, said, "We are very proud to collaborate with NASA's world-class team of scientists and researchers on the continued development of Firefly to advance mission-critical applications for point-of-need diagnostics, both in space and on the front lines to protect our nation from future bioterrorism threats."

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PathSensors Introduces Portable Zephyr Pathogen Identifier System

PathSensors Inc., an environmental testing bioscience company, is introducing the portable Zephyr Pathogen Identifier system, which delivers extremely rapid, highly reliable detection of bacteria, virus and toxins in powder and liquid samples in minutes.

The Zephyr Identifier uses CANARY® (Cellular Analysis and Notification of Antigen Risks and Yields) technology which is licensed from the MIT-Lincoln Laboratory. With CANARY® biosensors, the rapid kinetics and signal amplification of cell-based signaling enables pathogen detection at sensitivities down to 50 cfu/pfu within 5 minutes.

Zephyr detects foodborne pathogens such as salmonella, E. coli, listeria and campylobacter in dry foods, meats and on food preparation surfaces; significant issues for food producers worldwide. Currently, PathSensors is engaged in programs with the USDA and FDA to identify pathogens in poultry and plant materials.

“The portable Zephyr is as an easy-to-use, field deployable pathogen identification system, typically requiring less than a half hour of operator training,” explains Ted Olsen, president of PathSensors. “The user interface walks the operator through each assay step, making the system extremely user-friendly.”

PathSensors is currently working with other government organizations, including first responders, to deploy the portable Zephyr system in the field to provide fast, sensitive detection of biological risks. “Typically, field samples are transported to regional laboratories for identification testing which can take critical hours,” Olsen explains. “Zephyr technology enables quick testing onsite in minutes.”

At launch, PathSensors is offering reagents for rapid identification of the most common bio-threat agents. Initially, these pathogens include anthrax, ricin, botulinium toxin, smallpox, the plague and tularemia. The new Zephyr system expands PathSensors’ line of rugged instrumentation that includes The BioFlash-AF® Identifier for aerosol collection and identification of airborne pathogens in the ag-poultry environment, using a single sample.

PathSensors now offers a complete line of instrumentation that can identify biological agents in any sample matrix: powder, liquid or aerosol. The instruments can be used as standalone or as part of an integrated biological detection system.

The existing product line also includes the rugged PathSensors BioFlash-E Biological Identifier, a high-volume, high-performance aerosol sampler for building, event and mailroom applications.

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BioFire's FilmArray(R) Gastrointestinal Panel Receives FDA Clearance

bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire, its new molecular biology affiliate, received U.S. Food and Drug Administration (FDA) 510(k) clearance for the FilmArray(R) Gastrointestinal (GI) Panel(1) . The 22-target FilmArray(R) GI Panel allows a syndromic approach(2) to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. It is the most comprehensive gastrointestinal test to be cleared by the FDA and contains several pathogens receiving FDA clearance for the first time.

Current diagnostic practice requires choosing among multiple tests that can be laborious to perform and do not cover the breadth of pathogens that cause gastrointestinal illness. These tests are often carried out in a stepwise fashion, and the process can take too long to aid in timely pathogen-specific treatment decisions. Unlike open-platform testing that leaves labs vulnerable to cross-contamination, the FilmArray(R) is a closed-system that integrates sample preparation, amplification and detection. In addition, the FilmArray(R) GI Panel is performed directly from stool in Cary Blair transport media, takes only two minutes to set up, and produces results in about an hour. The FilmArray(R) GI Panel is a user-friendly alternative to the time-consuming, labor intensive, costly and technically complex testing methods used today and improves accuracy, timeliness and diagnostic yield for all 3 pathogen types.

"The excitement about this panel from the medical community has been astounding" said Randy Rasmussen, bioMérieux Corporate Vice-President Molecular Biology & CEO of BioFire Diagnostics. "We view this panel as a game-changer in the diagnosis of infectious diarrhea, delivering accurate and timely results. The breadth of pathogens on our GI Panel provides physicians with the underlying causes of gastrointestinal infectious disease, which aids with treatment decisions for their patients."

Despite advances in food safety, sanitation and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups. In the United States, between 200 and 375 million episodes of diarrheal illness are estimated to occur each year, resulting in 73 million physician visits, 1.8 million hospitalizations, 3,100 deaths and $6 billion in medical care and lost productivity. Early diagnosis facilitates timely and appropriate therapeutic interventions that can alleviate symptoms and prevent secondary infections(3) . In addition, rapid determination of the exact cause will assist in managing contacts and stopping the transmission of the pathogens which are contagious, thereby contributing to improved Public Health.

As of today, the FilmArray(R) menu comprises three panels, the Respiratory Panel and the Blood Culture Identification Panel (both of which are CE-marked and FDA-cleared) and the GI panel which is FDA-cleared. The latter clearance has been received in less than three months. BioFire anticipates CE IVD marking of the FilmArray(R) GI Panel in late spring of 2014.

Additionally, BioFire has initiated studies for its Meningitis-Encephalitis Panel, with FDA submission expected in 2015.

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FDA Issues Emergency Use Authorization for Influenza A/H7N9 Rapid Test

Hong Kong reported a new case of influenza A/H7N9 last week and the CDC warned that the virus could make its way to the U.S.

Influenza A/H7N9, a new strain of the avian influenza first identified in China in 2013, kills one in three people infected. The virus moved across China in two successive waves, crossing the border into Hong Kong, Taiwan and Malaysia.

The privately held Arbor Vita Corporation announced this week that the FDA issued an emergency use authorization for its AVC A/H7N9 influenza rapid test for the presumptive detection of the virus in patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors.

“The AVC A/H7N9 Influenza Rapid Test is a potent early surveillance tool,” Dr. Peter Lu, the CEO of Arbor Vita Corporation, said. “This test is suitable for early, point of care screening in strategic locations such as borders checks, airports, US company clinics in China, etc. Early detected infections are then confirmed by molecular tests, such as PCR in large reference laboratories.”

“We are proud and excited to receive FDA’s authorization under an EUA for the first rapid test able to diagnose patients suffering from this deadly respiratory infection.” Lu said. “We applaud the FDA’s efforts to authorize the test. This test may prove to be critical at containing a potential avian influenza pandemic.”

Arbor Vita was approached by the U.S. Navy in spring 2013 to develop a simple and accurate test to detect the virus after Arbor Vita demonstrated success in developing a similar test for influenza A/H5N1. The test was required to be simple enough for non-laboratory personnel to use in the field.

“We have confirmed that Arbor Vita’s test can detect human H7N9 viruses. The dual testing system – Influenza A virus and A/H7N9 virus – clearly has a great advantage.” Dr. Leo Poon, an associate professor at the Center of Influenza Research and School of Public Health at the University of Hong Kong, said.

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New Diagnostic Test Aims to Prevent Wines with ‘Barn-Yardy' Odor from Brettanomyces

Invisible Sentinel Inc. and Jackson Family Wines on Monday launched Veriflow BRETT, a diagnostic test designed to rapidly detect a wine-­spoiling yeast.

The Philadelphia medical device company formed a partnership with the California winery in January to test applications of its proprietary Veriflow technology — used to detect the presence of specific microorganisms and pathogens in food and beverages — in the wine industry.

Brettanomyces, the wine-­spoiling yeast, produces compounds that, in excess, can foul the taste of wine and give it a “barn-yardy” odor. Current methods of on-site testing for Brettanomyces, according to the companies, are time-consuming. As a result, the yeast can continue to accumulate before corrective measures are initiated and more product is subject to spoilage.

“Our collaboration with Jackson Family Wines has expedited the development and commercialization of a paradigm changing tool for rapid detection of Brettanomyces at the winery,” said Nick Siciliano, CEO of Invisible Sentinel.

Hugh Reimers, executive vice president and chief operating officer of Jackson Family Wines, said, Veriflow BRETT is easy to use and it quickly informs winemakers of Brettanomyces levels. Reimers said they are already seeing interest in the diagnostic product from other vintners across the globe.

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Luminex Announces European Unveiling of its New Molecular Diagnostic Sample-to-Answer System

Luminex Corporation announced it will unveil its new sample-to-answer system for infectious disease testing, ARIES(TM) at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). ARIES' scalable throughput, easy to use design, and networked data management software will deliver rapid results with a simple workflow.

The five assay launch menu targeted for the ARIES system will include: Flu A/B and RSV, HSV 1&2, Norovirus and Clostridium difficile (C. diff). Future menu items will be announced at a later date.

"ARIES will revolutionize molecular diagnostic testing with a system that integrates seamlessly into the laboratory," said Russell W. Bradley, senior vice president, corporate development and global marketing. "Enabling laboratories to produce faster results, and better manage their QC and compliance requirements can increase service levels to hospitals and doctors for improved patient care."

The unveiling will take place at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) May 11, 2014 at 11am CEST, booth #23. Russell W. Bradley will introduce the innovative sample-to-answer system, ARIES, and give a short demonstration.

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Interactive Training and Rapid Diagnostic Testing Reduces Over-Diagnosis of Malaria

A study published on Friday in The Lancet Global Health showed countries where malaria is endemic should rollout malaria rapid diagnostic tests (RDTs) at the same time new training programs are integrated into the medical care system.

Researchers at the Artemisinin-based Combination Therapy Consortium in the London School of Hygiene and Tropical Medicine studied the use of RDTs combined with basic and comprehensive training programs in Cameroon. Results showed 31 percent of patients attended by clinicians who took the comprehensive training received a malaria drug they didn’t need.

The clinicians who took the basic training course gave 52 percent of their patients medication they didn’t need. A control group representing standard procedures showed 84 percent of patients received medication they didn’t need.

“If we are serious about improving the targeting of malaria medicines by using RDTs, then there needs to be a far greater focus on behaviour change,” Lead Study Author Virginia Wiseman said. “This study, the first of its kind in Cameroon, highlights that health workers not only need training to diagnose and treat malaria, but most of all need the confidence to put what they learn into practice and to communicate more effectively with patients about why they are tested and that fever is not always caused by malaria. Our results suggest that a good training program designed to translate knowledge into practice could dramatically reduce over-diagnosis of malaria in Cameroon and prevent the wastage of valuable medicines.”

The World Health Organization recommends that patients be tested for malaria before receiving medication, but the illness is traditionally diagnosed based on symptoms.

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Akers Biosciences Starts Clinical Trials for PIFA PLUSS Chlamydia Assay

Akers Biosciences, Inc. (the "Company" or "ABI"), a leading designer and manufacturer of rapid diagnostic screening and testing products, has commenced clinical trials in the USA for its PIFA PLUSS Chlamydia Assay, the world's first rapid test for Chlamydia diagnosis using a finger stick blood sample.

The study will consist of three populations of patients totaling 200-250 subjects; the population groups will contain normal, newly infected and actively infected subjects, as well as previously infected and treated subjects. It is estimated that the study will last approximately three months, but that time could be extended based on the prevalence of Chlamydia-positive subjects. Regulatory documentation will be submitted in both the US and EU shortly after conclusion of the studies with a view towards seeking regulatory approval to sell the tests.

ABI's PIFA PLUSS Chlamydia Assay, based on the Company's proprietary particle immunofiltration assay technology, provides results in approximately five minutes. ABI's assay was designed to make screening widely available and easy and, unlike current testing procedures, the Company's assay can be run in a wide range of settings including doctors' offices, clinics and school or university health centers. The Company believes that the test, once approved in the US, will be eligible for insurance reimbursement.

Chlamydia trachomatis is one of the most commonly reported notifiable diseases in the US and the UK. It is among the most prevalent of all sexually transmitted diseases ("STDs") and, since 1994, has comprised the largest proportion of all STDs reported to the United States Centers for Disease Control and Prevention ("CDC"). According to the CDC, there are an estimated 2.8 million cases annually in the US.

"Half of all Chlamydia cases in the US go undiagnosed, despite the disease being easily cured with single dose antibiotics," said Raymond F. Akers Jr., Ph.D, Executive Chairman. "Part of the reason for this is that current methodologies remain costly and time consuming and are typically analyzed in a laboratory following an endocervical or urethral swab sample collection. Our technology aims to increase the detection rate of this serious infection by making it easy for individuals to get near-instant results from a simple finger stick blood test, performed confidentially and in a convenient setting," added Dr. Akers.

The clinical trials will be led by Adam Sobel, MD, who will be the principal clinical investigator, and will be performed by the Sobel Medical Group and the Mazzoni Center, both located in Philadelphia, PA.

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