Made-in-Singapore H5N1 Bird Flu Diagnostic Kit - Detects All Known Strains of H5N1 Virus with a Single Test

The close collaboration between scientists from the Experimental Therapeutics Centre (ETC) under the Agency for Science and Technology Research (A*STAR) and clinicians from Tan Tock Seng Hospital (TTSH) has enabled the successful development of the most comprehensive and rapid H5N1 bird flu test kit available to date. With this highly advanced kit, doctors can now rapidly detect all existing strains of the H5N1 viruses in a single test with almost 100% accuracy, within a few hours. This is a big boost to public healthcare system and a great stride forward in pandemic preparedness against this highly infectious disease worldwide.

The bird flu virus, scientifically termed as the Avian Influenza virus, is usually lethal to the birds and normally does not transmit to humans. However, highly lethal and contagious strains like H5N1 Avian Influenza A virus that can 'jump' from birds to human have been reported to cause serious infections and even death rates as high as 60% in infected patients . Although anti-viral treatment is available, the potential for H5N1 bird flu virus to spark a pandemic remains a serious threat to public health as most humans do not have immunity to the H5N1 virus. Therefore, to successfully curb the spread of the disease during an outbreak, accuracy and speed of detection on the type of H5N1 virus is of essence for effective infection control intervention and patient management.

The current gold standard for H5N1 detection recommended by the World Health Organization (WHO) is only able to detect three out of the 10 distinct genetic groups (clades 1, 2 and 3). To detect all existing strains of H5N1 with the WHO detection method would not be possible. The made-in-Singapore H5N1 test kit, which is more accurately known as the H5N1 real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay, is the only detection kit currently available on the market that can accurately and rapidly detect all known strains of the H5N1 Avian Influenza A virus in a single test within a matter of hours.

Co-developed by Dr Masafumi Inoue, a Senior Research Scientist and Project Director of Technology Development from ETC and Dr Timothy Barkham, a senior consultant of Laboratory Medicine from TTSH, this newly launched H5N1 test kit has been clinically validated by several hospitals in Southeast Asia.

"We are excited to be able to contribute to the fight against H5N1 virus with our expertise and know-how. Our technology has greatly simplified and accelerated the process of detection and identification of new H5N1 variants. Such information is especially critical when the virus mutates to become more dangerous, such as in drug resistance." said Dr Inoue.

To enhance its usability, this new H5N1 test kit is also purposefully designed to be compatible with the previously launched "4-plex" Influenza diagnostic kit . The latter is already adopted for use by several regional hospitals in Thailand. Using such multiplex assays enables simultaneous detection and differentiation of the different types of influenza infection in a single test, which will save hospital labs and clinicians significant time and cost.

"While there have not been any reported H5N1 cases in Singapore, this mutating subtype of influenza virus type A continues to be a concern. The ability to detect and characterise influenza strains remains important in the management of the disease. With this latest H5N1 assay, we can easily combine it with our previous 4-plex Influenza kit to differentiate which strain of Influenza is present with one test, giving a definite diagnosis and faster turnaround for our patients and our colleagues in infection control and public health," said Dr Barkham.

Local Small and Medium Enterprise (SME), AITbiotech Pte Ltd, a regional provider of genomic services and molecular diagnostics kits, has recently signed a licence agreement with Exploit Technologies Pte Ltd (ETPL), the technology transfer arm of A*STAR, to market this H5N1 kit regionally.

"The new H5N1 test kit from A*STAR is a significant addition to AITbiotech's existing portfolio of products for Influenza virus screening and surveillance. In light of the recent H5N1 outbreak in this region, we believe that this test can play a vital role for governments and public health institutions to effectively fight and control the outspread of any H5N1 virus", said Mr Alex Thian, Founder and Chief Executive Officer of AITbiotech.

Previously, AITbiotech has acquired several other molecular diagnostic licenses from ETPL for swine flu mutation surveillance and for multiple pathogens detection, including Dengue, Chikungunya and Mycobacterium Tuberculosis.

"Licensing these highly sophisticated assays from A*STAR has given AITbiotech a springboard into the highly competitive market of Molecular Diagnostics. With our expanded capabilities, we are now able to provide a comprehensive suite of diagnostic services for a range of infectious diseases to the research, healthcare and biomedical industries in Singapore and Asia," added Mr Thian.

"This collaboration between A*STAR, TTSH and AITbiotech is a great example of how public and private sectors can partner to drive impact in Singapore's healthcare and biomedical industries. We remain committed in our role to transfer A*STAR technologies to help SMEs like AITbiotech stay competitive by delivering products with direct societal benefits," said Philip Lim, CEO of ETPL.

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Cepheid Announces European Release of Xpert CT/NG and Xpert CT, Delivering Rapid Detection and Differentiation of Chlamydia and Gonorrhoeae

Cepheid today announced that both Xpert® CT/NG and Xpert® CT have received CE marking, with shipments expected to begin immediately. Running on Cepheid's GeneXpert® System, the products are qualitative in vitro molecular diagnostic tests for the rapid detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). With results in less than 90 minutes, new opportunities for same-day patient consultation and treatment are now available.

"We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG -- a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability," said John Bishop, Cepheid's Chief Executive Officer. "We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients -- the critical first step in effectively managing these diseases."

"For the first time, we are able to offer highly accurate results we can act upon while the patient is still in the clinic. This may have far-reaching effects, such as improving contact tracing and reducing ongoing spread of infection in the community, as well as being popular with our patients," said Dr. Simon Goldenberg, Consultant Microbiologist, Guy's & St. Thomas' NHS Foundation Trust, London. "I am impressed with the highly accurate results obtained with Xpert CT/NG. The simplicity of sample prep and the easy-to-use format of the GeneXpert cartridge provide same-day results in around 90 minutes."

Gonorrhoeae and Chlamydia are sexually transmitted infections (STIs). Both are easily treated when quickly detected and managed. However, according to the European Centers for Disease Control and Prevention (ECDC), the rate of reported chlamydial infections doubled during the last decade. Complicating the problem are today's slower test methodologies, which make timely patient consultation and treatment a challenge for this reportable disease.

Gonorrhoeae rates are also rising, often as a co-infection with Chlamydia. And current testing protocols for Neisseria gonorrhoeae are often problematic due to cross-reactivity with other organisms, often requiring an additional confirmatory test. These delays and coordination issues can significantly hamper communication and consultation, leaving both patients and their partners uninformed and untreated.

"The Xpert CT/NG test incorporates several novel features -- namely, target redundancy for NG and a novel sample adequacy control -- that we think will help overcome the limitations of first-generation technologies," said David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert CT/NG is clearly the most sophisticated test in its class, yet it can be performed on-demand by virtually any laboratory in order to maximize the medical impact of the results."

Xpert CT/NG will be immediately available as a CE-marked product. Visit www.cepheidinternational.com for Cepheid's complete CE IVD menu of Xpert tests. Xpert CT/NG is expected to become available in the United States in late 2012.

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.

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Seegene and DuPont Nutrition & Health Agree to Develop Highly Multiplexed Molecular Assays for Food Safety Testing

Seegene Inc., a leading developer of multiplex molecular technologies and diagnostic tests, and DuPont Nutrition & Health, a leading provider of rapid, molecular diagnostic systems, have agreed to jointly develop new, highly multiplexed assays for the detection of foodborne pathogens.

Combining novel technologies from Seegene with the powerful chemistry and analytics of the BAX(R) System from DuPont allows for a potential step-change in pathogen testing. For example, Seegene DPO(TM) technology generates consistently high specificity by eliminating primer competition, and TOCE(TM) technology allows the identification of multiple targets in a single dye channel. With this agreement, DuPont and Seegene are seeking to develop highly multiplexed, real-time PCR assays that provide for rapid detection and differentiation of 10 or more organisms from a single sample in a single test.

"We are constantly seeking innovative collaborators to develop science-based solutions that will meet evolving needs for food safety and quality," said George Tice, research and development director, DuPont Qualicon Diagnostics. "This integration of unique Seegene technologies with robust diagnostic systems from DuPont will give the food industry increasingly powerful tools to help protect their products and their brands."

"Working with DuPont Qualicon Diagnostics opens a significant new market opportunity for our portfolio of multiplex molecular technologies," said Jong-Yoon Chun, founder and CEO of Seegene. "By leveraging these novel technologies, we can advance from the current 'one test, one pathogen' approach to a 'one test, many pathogens' paradigm. This will significantly improve the efficiency and effectiveness of food safety testing, and help to reduce the prevalence of foodborne illness."

This initiative marks the entry of Seegene's multiplex technologies into the multi-billion dollar food safety testing market. According to The Centers for Disease Control and Prevention, foodborne illness each year in the United States alone affects 48 million people.

DPO(TM) technology is a fundamental tool for blocking extension of non-specifically primed templates, generating assays that are both highly specific and highly sensitive. TOCE enables simultaneous multiplex testing, by using the differences in melting temperatures of designed artificial amplicons. Prior to TOCE, multiplex assays were difficult because even a small variation in amplicon sequences changes the melting temperature (Tm) of the amplicon. TOCE technology overcomes current limitations of Tm analysis and allows testing of multiple targets with one fluorescent label by ensuring that sequence variation does not change the melting temperature.

Food processing companies around the world rely on the BAX(R) system from DuPont Qualicon Diagnostics to detect pathogens or other organisms in raw ingredients, finished products and environmental samples. The automated system uses leading-edge technology, including polymerase chain reaction (PCR) assays, tableted reagents and optimized media to detect Salmonella, Listeria species, Listeria monocytogenes, E. coli O157:H7 and STEC, Cronobacter, Campylobacter, Staphylococcus aureus, Vibrio, and yeast and mold. With certifications and regulatory approvals in the Americas, Asia and Europe, the BAX(R) system is one of the most advanced pathogen testing system available to food companies.

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Cepheid Receives FDA Clearance for GeneXpert Infinity-80 System for Initial Use with Xpert Flu Assay

Cepheid today announced that the U.S. Food & Drug Administration (FDA) has cleared its GeneXpert® Infinity-80 System, a high-throughput automated molecular system designed to deliver around-the-clock results for a wide variety of clinical testing applications. The GeneXpert Infinity-80 has been initially cleared in conjunction with Cepheid's Xpert® Flu test.

"With the capability of generating more than two thousand automated results per day, the GeneXpert Infinity-80 is the most efficient, highest throughput molecular diagnostic system on the market -- delivered in the same footprint as our current Infinity-48 System," said John Bishop, Cepheid's Chief Executive Officer. "The Infinity-80 also offers a user experience that's generations ahead of alternative solutions -- enabling true walk-away ease-of-use and minimal hands-on time."

The GeneXpert Infinity-80 employs the same proven, robust GeneXpert module technology used across the entire GeneXpert System family. The Infinity-80 is available in configurations of 16, 24, 32, 40, 48, 56, 64, 72, and 80 modules. In every configuration, the system is designed to adapt to any workflow requirement -- on-demand, batch, or STAT testing.

The GeneXpert Infinity-80 System will be available for shipment on July 1st.

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Microorganism ID: Bacteria Identification Service by Altogen Labs

Altogen Labs CRO, a preclinical contract research laboratory, announced its launch of microorganism ID bacteria identification service today. Microorganism identification and bioinformatic sequence characterization services are available for all types of bacteria, fungi, yeast, algae, soil, animal, and microbial samples for both R&D research studies and clinical applications. Microorganism identification service is designed to support and accelerate patent applications, genotypic bacterial identification, microbial ID testing, novel microorganism discovery, and bacteria detection.

This service helps identify the microorganisms present in samples of soil, marine environments, isolated bacteria, clinical samples, yeast, and fungi, as well as periodically establish the authenticity of cultures by detecting contamination of stock cultures. The 16S rDNA-based protocol established by Altogen Labs enables identification of over 5,000 species of bacteria and various other microorganisms present in environmental or clinical samples. Identification is performed on a genus level to enable species and strain identification and to establish similarity of the identified microorganisms to other known species/strains. Altogen Labs ribosomal RNA gene sequencing approach is based on over 100 primer sets and provides improved bacterial identification and aids in discovery of novel bacteria, especially bacteria that cannot be identified by conventional phenotypic methods or are refractory to biochemical identification - an important concern for both environmental samples and clinical specimens.

DNA sequencing is currently the most accurate and reliable method for identifying microbes in both environmental and clinical samples. Application of this technique can be used to establish contaminant identity in water or fuel samples. Similarly, it can be used to establish bacterial identity in clinical specimens. Altogen Labs provides sequencing and bioinformatics expertise, personalized service and rapid turnaround time. Bacterial identification service has important applications in several industries, such as pharmaceutical, biotechnology, diagnostic, agricultural, and legal, in which the exact ID of microorganisms results in expediting IP filing date, clinical processes, and basic science research.

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IntelligentMDx Announces CE-Marking of a New High-Throughput Test for Group B Streptococcus Intended to Improve Women's Health and Prenatal Care

IntelligentMDx (IMDx) announced that it has obtained CE-marking for a new automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen. GBS is responsible for life-threatening bacterial infections in newborns, including sepsis, meningitis, and pneumonia. The IMDx(TM) GBS for Abbott m2000(TM) test utilizes real time PCR, operates on the Abbott m2000 system and addresses the needs of hospitals to rapidly screen large numbers of patients for GBS and make quick informed decisions about antibiotic treatment.

The IMDx GBS for Abbott m2000 test offers robust and accurate detection of GBS from both direct swabs and enriched culture broth samples. With this test, results for up to 48 patient samples can be obtained simultaneously in approximately 5 hours or less. When compared against traditional culture methods, the IMDx GBS for Abbott m2000 test exhibits 95.5% sensitivity and 98.3% specificity with direct swabs and 100% sensitivity and 100% specificity with enriched culture broth samples.

"At IMDx we strive to develop tests that will address the specific needs of target communities," says Alice Jacobs, MD, Chairman & CEO of IMDx. "Testing for GBS is a critical step in eliminating the incidence of newborn infection. The IMDx GBS for Abbott m2000 assay is intended to improve women's health and prenatal care by providing physicians with the confidence to make intelligent treatment choices for their patients."

The IMDx GBS for Abbott m2000 assay is the third CE-marked test developed under a multi-year distribution agreement between IMDx and Abbott whereby IMDx designs, develops, obtains regulatory clearances, and manufactures assays for the Abbott FDA cleared m2000 instrument. In addition to the new GBS assay, the IMDx CE-marked test menu for use on the Abbott m2000 system includes real-time PCR assays for the detection of vancomycin-resistant enterococci (VRE) and toxigenic C. difficile.

*The IMDx GBS for Abbott m2000 assay is CE-marked and not available for sale in the U.S. or Canada.

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Idaho Technology Receives FDA 510(k) Clearance for Expanded FilmArray® Respiratory Panel

Idaho Technology, Inc., a privately held clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of five additional pathogens for its FilmArray Respiratory Panel (FilmArray RP), a user-friendly Multiplex pathogen detection system. FilmArray RP is now FDA-cleared for 20 viral and bacterial respiratory pathogens.

"We are pleased to offer a more robust and simpler way to test for upper respiratory tract infections," said Kirk Ririe, Chief Executive Officer of Idaho Technology. "Gaining clearance of these additional pathogens for FilmArray RP is an accomplishment long-anticipated by our users in the hospital clinical laboratory community because it improves laboratory testing capacity while providing the fastest way to better results."

With the addition of these five pathogens, the FilmArray RP now includes the first FDA cleared assays for 8 of the 20 organisms on the panel. Furthermore, the FilmArray RP is the only FDA-cleared panel capable of distinguishing between certain bacterial and viral respiratory infections. This represents a significant advancement in the field of infectious disease detection, with the potential to provide clinical laboratories and physicians with more comprehensive, actionable information to guide treatment decisions and improve patient outcomes.

The additional five pathogens are; Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. 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.

Mr. Ririe Continued, "Our expanded respiratory panel highlights the diagnostic potential of our dynamic and innovative FilmArray platform. After almost one year on the market with FilmArray RP, we have been very encouraged by the market acceptance we've received. We expect, based on current demand for our product and our growing pipeline of additional clinical diagnostic tests, to establish a leadership position in clinical diagnostics, building upon our legacy and expertise in pathogen identification."

Idaho Technology is currently developing additional applications for their 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.

FilmArray RP is Idaho Technology's first clinical diagnostic test designed to run on the Company's novel FilmArray system, which represents a significant advancement in user-friendliness and multiplex infectious disease testing capability for hospital clinical labs. FilmArray RP rapidly detects nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. Requiring only two minutes of hands-on time, FilmArray RP has about a 1-hour turnaround time, and simultaneously tests for the following panel of respiratory pathogens: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1 2009, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. FilmArray RP has received FDA-clearance for twenty targets and is available for use by hospital and clinical laboratory professionals in the United States. In addition, the European version of FilmArray RP is CE IVD marked for twenty-one targets. Idaho Technology is continuing to develop a broader test menu for its FilmArray system, including a blood culture ID panel, gastrointestinal panel, and an STD panel.

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BioSpec Global Solutions TOG's 9000 and 3000 Ready for Commercial Market

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

BioSpec President Don Saunders said, "We have completed all testing on the TOGS 9000 and home version TOGS 3000, and are ready for the commercial and retail market. Our intent is to find a retail and commercial manufacturer and distributor for the products."

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 system will offer same day results (~ 3 to 14 hours) and simultaneous detection and enumeration of bacteria.

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PositiveID Corporation's MicroFluidic Systems Subsidiary Makes Significant Progress in Preparation for $3 Billion BioWatch Procurement

PositiveID Corporation ("PositiveID" or "Company"), an emerging growth company and developer of advanced technologies for diabetes management as well as sophisticated airborne bio-threat detection systems for America's homeland defense, today announced it has made significant progress in testing its M-BAND, Microfluidics-based Bioagent Autonomous Networked Detector, in preparation for the Department of Homeland Security's $3 billion BioWatch procurement. The Company's M-BAND system detects five organisms on the CDC Select Agents List, which is a requirement for BioWatch.

M-BAND, developed under contract for the Department of Homeland Security by MFS, is an early warning system designed to detect the intentional release of aerosolized biological agents. It runs autonomously for up to 30 days between service cycles, continuously analyzing air samples, typically in high-traffic areas, for the detection of bacteria, viruses, and toxins with results in as little as three hours. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in aggregate. Designed with a high level of operational flexibility, M-BAND can be remotely set to detect for DNA-based pathogens alone, with or without either RNA-based organisms or toxins, or for all three types of pathogens simultaneously at remotely programmable intervals.

The M-BAND instrument offers a number of advantages over similar products, including decreased consumable and operating costs, a small footprint, a closed operating environment and significant flexibility of operation. M-BAND has been designed and field tested to operate continuously for 30 days unattended between scheduled services. It also operates using industry gold-standard TaqMan® PCR (polymerase chain reaction) chemistry.

In addition to the BioWatch opportunity, the Company has submitted or is in the process of submitting bids for other government contract opportunities totaling more than $16 million across six different government agencies for both its M-BAND and Dragonfly™ Rapid MDx Cartridge-based diagnostic system.

William J. Caragol, Chairman and CEO of PositiveID, said, "As we prepare for the final request for proposal for BioWatch to be released from DHS, we have continued our internal testing of M-BAND. Our system is fully functional and, we believe, one of the only technologies capable of addressing the requirements of the BioWatch procurement. Furthermore, we believe our system not only performs better than the competition but also has a lower total cost of ownership."

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3M Molecular Detection Assay for Salmonella Receives AOAC-PTM Approval

3M Food Safety announced today that its new 3M™ Molecular Detection Assay – Salmonella has received AOAC-PTM Certification (#031208) from the AOAC Research Institute’s Performance Tested Methods Program.

The 3M™ Molecular Detection System was first introduced in December 2011 as an innovative combination of two technologies – isothermal DNA amplification and bioluminescence detection – that offers a reliable and rapid qualitative method of pathogen detection in enriched food, feed and food process environmental samples. The AOAC-PTM certification validates 3M’s unique, molecular approach as equivalent to or better than standard FDA and USDA reference methods for the detection of Salmonella. It is projected that there are as many as 2 to 4 million cases of salmonellosis every year in the U.S.

The AOAC Research Institute bases certification of methods on independent study results demonstrating that a given method meets the claims expressed in package inserts. For the 3M Molecular Detection Assay - Salmonella method PTM study, artificially contaminated samples were enriched and evaluated by the 3M Molecular Detection System as well as the appropriate FDA or USDA FSIS reference methods. These samples included evaluation of meat, poultry, eggs, seafood, produce and pet foods. No statistically significant differences in sample results were observed between the 3M Molecular Detection Assay - Salmonella and these reference methods.

“This method validation is an important milestone, constituting the first of what we believe will be many confirmations of a robust and capable technology,” said DeAnn Benesh, regulatory affairs specialist with 3M Food Safety. “Evaluation of Salmonella, and other pathogens using this technology, continues to be very promising, underscoring how the 3M Molecular Detection System’s simple, streamlined method provides accurate results.”

3M Food Safety is pursuing additional global method validations for the 3M Molecular Detection Assay – Salmonella to present to the marketplace. The company developed the 3M Molecular Detection System and its test kits with the needs of its worldwide food processing clientele in mind, involving them early on in the design process. Ultimately, a small but powerful technology was produced, capable of targeting and amplifying nucleic acid in enriched samples with great success.

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OraSure Technologies Applauds CDC Proposed Draft Guidelines for Testing of Baby Boomers for Hepatitis C

OraSure Technologies, Inc. issued a statement in strong support of the Center for Disease Control and Prevention (CDC) draft guidelines proposing that all U.S. baby boomers get a one-time test for the hepatitis C virus (HCV). The CDC issued a press release ( http://www.cdc.gov/nchhstp/newsroom/HepTestingRecsPressRelease2012.html ) proposing that all persons born between 1945 and 1965 -- approximately 81 million according to the 2010 Census -- be tested for HCV. CDC's draft recommendations will be published in the Federal Register on Tuesday, May 22, and will be made available for public comment until June 8.

The CDC also announced the release of a $6.5 million funding opportunity announcement to expand testing of hepatitis.

According to the CDC, identifying hepatitis C infections early will allow more baby boomers to receive care and treatment, before they develop life threatening liver disease. The CDC believes that one in 30 baby boomers has been infected with hepatitis C, and most don't know it. They estimate that more than 2 million U.S. baby boomers are infected with HCV and are five times more likely to be infected than other adults. Hepatitis C causes serious liver diseases including liver cancer, which is the fastest-rising cause of cancer-related deaths, and the leading cause of liver transplants in the United States, according to the agency.

"Hepatitis C can now be more effectively treated in a high percentage of people with HCV infection, making expanded testing -- particularly among the baby boomer generation-- a critical step in fighting this insidious epidemic," said Douglas A. Michels, President and CEO of OraSure Technologies.

OraQuick(R) HCV is the only FDA-approved rapid, point-of-care test for the detection of antibodies to the hepatitis C virus utilizing fingerstick and venipuncture whole blood specimens in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes.

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DFRL transfers rapid test technology, including assays, to Indian Army

Defence Food Research Laboratory (DFRL), Mysore, has transferred technology of rapid tests, which includes miniaturised bio-chemical kits, antibody and DNA-based tests and assays that are modifications of conventional tests to speed up the analysis of food contamination which contains animal products like meat, fish, and poultry, to the Indian Army. With the help of these meat testing kits, the Army will be able to access microbial quality, detect cold and live slaughtered meat and E coli.

Foods from animals, principally meat, fish, milk and eggs, can potentially be contaminated with more pathogens. Traditionally, the concerns for food safety have focussed on zoonotic diseases. Food-borne diseases represent an important public health problems, significantly affecting people’s health with economic consequences, stated RR, nutrition expert, Central Military Veterinary Lab, Meerut.

Approximately 500 species of normally harmless bacteria are referred to as commensal bacteria colonise the human gastrointestinal tract, producing disease when normal anatomic or immunologic defenses are weakened. The principal invasive intenstinal bacterial pathogens of food animal origin are Campylobacter, Salmonella, Listeria, E Coli, Brucella, Yersinia and Vibrio. Nearly all are common harmless bacteria in cattle, swine and poultry that sometimes cause invasive infection in animals and humans. Vibrio, an exception, is found in shellfish and sea water. Other organisms of food-animal origin such as Enterococcus specialties and E coli strains that produce Shiga toxin, which could also enter and mix with harmless bacteria in the human gastrointestinal tract, stated the nutrition experts in a presentation on animal-borne pathogens in food.

According to the experts, products contaminated with food-borne pathogens often look and smell the same as food. Therefore visual inspection is not enough to ensure safe food and ingredients. Laboratory-based surveillance of animals, food and humans is important both to detect and prevent food-borne pathogens from entering or spreading through the food chain as well as to identify food-borne disease outbreaks so that appropriate control measures can be taken.

Traditional methods to detect food-borne bacteria often rely on time-consuming growth in culture media, followed by isolation, biochemical identification and some times serology. The rapid detection of pathogens and other microbial contaminants in food is critical for ensuring the safety of consumers.

Recent advances in technology make detection and identification faster, more convenient, more sensitive and more specific than conventional assays. These new methods are often referred to as rapid methods. Some of these assays have also been automated to reduce hands-on manipulation.

Preventive measures comprise of implementation of food control systems which includes development of relevant and enforceable food laws, access to qualified food inspectors and effective food monitoring systems. This is where DFRL was also making its efforts to provide the testing technology to make the process easier at locations of the Indian Army where the experts could assess instantly and avert food-related diseases.

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Partnership Results in Innovative Rapid Diagnostics Technology

Little Rock based Vivione Bioscience, LLC, a manufacturer of new ultra high performance RAPID-B diagnostic system, in a press conference yesterday, officially announced its move to its new home, in some laboratory space at the Pine Bluff Arsenal.

In a collaboration between VB and the U.S. Food and Drug administration (FDA) and the National Center for Toxicological Research (NCTR) in Jefferson, they will test bacteria in key environments with a mission to revolutionize the clinical and medical fields, food and industrial safety, water safety and bio-defense by utilizing one compact universal platform for all diagnostic testing that can be used for bacteria, viruses and toxins. The new technology rapidly addresses methods for current unmet diagnostic needs as well as taking the place of outdated culture-based, immunology-based and molecular-based methods that take countless hours. It also provides more accurate results in only minutes to a few hours.

“The Alliance was first contracted by a Vivione representative in March 2011 concerning available lab space in Jefferson County, said Lou Ann Nisbett, Alliance President and CEO. There are some top-notch facilities here, and we certainly wanted to match those up with a biotechnology company like this that is poised to revolutionize food safety testing.” “We cannot envision a better company to be the first recipient of the Jefferson County Sales Tax incentive.

When we started that effort many years ago this is exactly they type of company we had in mind and hope to attract and we hope for a lot of good things here.” Mike Holcomb. We’re excited to welcome this biotechnology company to Jefferson County and proud to know that our community was selected as the right fit. It’s also gratifying to see our combined economic development efforts paying off, said George Makris, chairman of the EDCJC. We look forward to working with Vivione as it continues to grow and add new, knowledge based jobs and with other companies that might benefit from a location in close proximity to Vivione’s lab.”

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ArcDia Raises EUR 2.7 Million to Expand Multianalyte Point-of-Care Respiratory Tract Diagnostic Test

ArcDia Ltd, the manufacturer of world's only multianalyte point-of-care diagnostic system for respiratory tract infections, completed today EUR 2.7 million funding round to expand its mariPOC® diagnostics system. The round was led by Lifeline Ventures with the existing investors Biothom, Veraventure and private investors participating.

mariPOC® diagnoses nine common viruses and bacteria that are clinically important in respiratory tract infections - such as influenza A/B, RS-virus and parainfluenza 1/2/3 viruses - in a single swab test at point-of-care. The test enables targeted treatment decisions, saves staff time, provides reliable results rapidly and is economically feasible for broad diagnostics use. mariPOC® is based on the proprietary ArcDia™ TPX detection technology (nature biotech 2000:18). mariPOC® was launched to the European market in late 2010, and the product has been in routine clinical use in major hospitals for more than a year. The first distribution agreement was signed in April with Laboratories Leti S.L.U., the Spanish market leader in diagnostic testing of pneumo-respiratory diseases.

"Simply, instead of performing multiple tests that take time to administer and diagnose, and may be difficult to read, mariPOC® provides automated analysis for nine pathogens in one sample in 20 minutes - and with a clear, readable answer. No other diagnostics test platform has been able to provide this functionality and cost-effectiveness to enable respiratory tract infections testing at point-of-care", says Dr Aleksi Soini, CEO at ArcDia Ltd.

"Before mariPOC®, point-of-care multianalyte diagnostic platforms have been too complicated, expensive, difficult-to-use and inaccurate for respiratory tract infections.mariPOC® is taking into account clinical, economic and scientific mattersto enable multianalyte diagnostics for this world's most prevalent disease cluster", comments Timo Ahopelto, Founding Partner at Lifeline Ventures.

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Burgeoning Molecular Diagnostics Market Propels the Global DNA Probes-Based Diagnostics Market, According to New Report by Global Industry Analysts, Inc.

GIA announces the release of a comprehensive global report on DNA Probe-Based Diagnostics markets. The global market for DNA Probe-Based Diagnostics is forecast to reach US$30 billion by the year 2017, driven by the rapidly expanding molecular diagnostics market. Growth in the marketplace is also expected to stem from affluent population and widening health insurance as well as medical reimbursements, which are making expensive cutting edge diagnostic tools such as DNA-based diagnostics increasingly affordable.

In the medical diagnostics laboratories of the 21st century, the ability to detect nucleic acids and proteins reign supreme. And given the need to rapidly and inexpensively determine the relevant DNA sequence information in a given organism, the potential of DNA probes-based diagnostics is huge. DNA probes also render themselves as a powerful tool for chromosomal mapping of single and multiple copy genes in the haploid genome. This invariably spells out an expansion in its applications in delineation and classification of many genetic diseases. The future envisages a DNA probe, which offers the ability to detect complex interrelationships between multiple gene expression and environmental factors, at the molecular level. This will help in detecting diseases, which are not the result of single-gene, or monogenetic disorders.

In the upcoming years, DNA diagnostic technologies are set to achieve superior efficiencies and improved activity in numerous application areas, including healthcare, biomedical research, toxicology, bioremediation, forensics and personnel identification, environmental monitoring, biomass operations, industrial processing, monitoring of infectious agents, and quality control in the food industry, animal husbandry, and agriculture. Also, the boom in the molecular diagnostics market is beginning to echo downstream into the DNA-probe based diagnostics segment. Further, affluent population and widening health insurance and medical reimbursements are additionally making expensive cutting edge diagnostic tools, such as DNA-based diagnostics, increasingly affordable.

The US represents the largest regional market for DNA Probe-Based Diagnostics market worldwide, as stated by the new market research report on DNA Probes-Based Diagnostics. In the US, the rapid growth of DNA-based diagnostics is leading to the development of new tests for the treatment of non-contagious diseases, such as diseases related to aging or chronic diseases. DNA-based diagnostic testing is rapidly entering the cancer setting as well. Europe trails behind the US, while the Asia-Pacific market is projected to register the fastest compounded annual growth rate of 21% during the analysis period. Infectious Diseases represents the key end-use market for DNA probes-based diagnostics worldwide. However, fastest growth is expected to emerge from Genetic Predisposition.

Despite the positive outlook, the marketplace continues to be plagued by challenges such as miniaturization, parallelization, and automation. In addition to these key challenges, improvements, and procedural refinement needs to be implemented in the areas of sample preparation, assay technology, detection systems, integration, data management and analysis. The culminated effect of all of these variables will help in determining the efficacy of the technology’s application in clinical diagnostics, in the years to come.

Major players profiled in the report include Abbott Molecular, Affymetrix, Inc., Becton, Dickinson & Company, Beckman Coulter Inc., bioMérieux, Celera Group, Gen-Probe Inc., Genzyme Corp., Luminex Molecular Diagnostics, QIAGEN, Roche Diagnostics, Siemens Healthcare Diagnostics, among others.

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QIAGEN Joins Grand Challenges in Global Health Initiative to Bring Advanced Point-of-Care Diagnostics to World's Poorest Countries

QIAGEN N.V. announced it has joined the Point-of-Care Diagnostics (POC Dx) Initiative led by the Bill & Melinda Gates Foundation and Grand Challenges Canada to create a new molecular diagnostics platform to serve resource-poor regions of the world.

QIAGEN has already started the development of a portable instrument based on its advanced molecular testing technologies for Point of Need applications. The development of affordable and portable diagnostic systems is one of the 16 "Grand Challenges in Global Health," an initiative that seeks to enhance healthcare in the world's poorest countries.

QIAGEN is joining more than 20 nonprofit, academic and corporate organizations in the POC Dx Initiative, which aims to catalyze a "diagnostics revolution" for the developing world. The goal of this initiative is to create new platforms that enable high-quality, low-cost point-of-care diagnosis and thereby make systematic and sustainable improvements in healthcare in the developing world.

QIAGEN's role is to develop an easy-to-use, portable molecular testing device that can perform diagnostic tests in the field, far from hospital or laboratory infrastructure. This task also encompasses the creation of a corresponding assay technology suited for use in low-resource settings. This project is part of the technology development phase of the POC Dx initiative, which will then integrate successful technologies into a multifunctional point-of-care platform. The POC Dx Initiative targets a broad array of related projects, such as putting together standards for diagnostics best suited to remote and impoverished settings, creating components such as low-cost devices to collect blood samples, or planning for the future integration of diagnostics into delivery of care in these areas.

"We are pleased to further expand our collaboration with the Bill & Melinda Gates Foundation to help bring the power of advanced molecular diagnostics to battle infectious and other diseases in developing regions. The new low-cost portable testing devices currently under development are intended to enable reliable, quick diagnosis and timelier treatment of patients. We believe that modern diagnostic technologies can have a very significant positive impact on developing countries, helping to save lives, reduce economic impacts, and curtail the spread of infectious diseases," said Dr. Ellen Sheets, Chief Medical Officer of QIAGEN. "QIAGEN has already placed thousands of Point of Need testing devices which are being used in a variety of applications in Molecular Diagnostics and Applied Testing. This experience will be instrumental in developing a new platform designed especially for the healthcare needs of developing countries and low-resource regions."

"The Point-of-Care Diagnostics Initiative seeks to transform the way we diagnose and treat patients in the world's poorest countries," said Gene Walther, Deputy Director Diagnostics at the Bill & Melinda Gates Foundation. "We hope that these groundbreaking ideas lead to new tools that can quickly diagnose disease and accelerate access to lifesaving health interventions for those in greatest need."

Through its own QIAGEN cares program, QIAGEN is working on multiple fronts to improve access to screening for infectious diseases in emerging countries. QIAGEN has previously collaborated with the Bill & Melinda Gates Foundation and PATH, an international nonprofit organization, in developing the careHPV Test, a state-of-the-art diagnostic specifically designed for low-resource settings to screen women for human papillomavirus (HPV), the primary cause of cervical cancer. The careHPV Test can be performed without access to a laboratory infrastructure and offers results in a few hours, a critical feature for women who travel to clinics from isolated villages and need to be treated the same day.

QIAGEN collaborates with a number of public health and nonprofit agencies to make its HPV screening technologies available in resource-poor areas of Africa, Asia and Latin America. In Applied Testing, the company is collaborating with the UN Food and Agriculture Organization (FAO) and the International Atomic Energy Agency (IAEA) in a pilot project designed to contain devastating animal diseases in developing countries using portable testing devices provided by QIAGEN.

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Rapid Pathogen Screening Secures Homeland Security Deal

Rapid Pathogen Screening Inc. has landed a contract with the U.S. Department of Homeland Security. The contract from the agency's Chemical and Biological Defense Division is for the development and manufacture of a rapid, point-of-care diagnostic test for use during a biological attack or pandemic. All the test would require from a patient is a finger stick for blood.

An RPS representative could not spell out too many details on the contract, but provided a few clues and added that the project has commercial applications on top of the governmental public health potential.

"There is a certain combination of things that the Department of Homeland Security gave us a grant to develop a test for," said RPS marketing manager Laura Lovejoy. "This would be used in a pandemic or a biological attack, with some sort of virus being released into an urban area."

RPS' proprietary and patented pathogen detection approach can be used with various bodily fluids. Theoretically, the kit format developed by RPS can be aimed at spotting almost any virus or bacterial threat, by measuring the presence of the antibody the body creates on its own to fight the invader. The company, which now employs 30, is beginning to market a second generation of its original test kit, designed to spot the highly contagious viral form of conjunctivitis, or pink-eye.

The new version of this kit, called AdenoPlus, was designated this week by the U.S. Food and Drug Administration as being a test with the lowest possible complexity. This means that the new version can be used by anybody in the medical office, including, for example, technicians or aides as well as doctors and nurses. If the test shows positive for viral conjunctivitis, the patient would know that antibiotics would not be useful. The medical office would be able to warn the patient that he or she remains highly contagious and needs to stay out of work, school or day-care.

The new connection with Homeland Security becomes part of a growing suite of big-league developmental relationships for this small research-oriented company. RPS already has received grants from within the Defense Department establishment to develop a test kit aimed at four different nerve agents, including the two best-known, Sarin and VX.

Last spring, the company separately formed a partnership with Celltrion of South Korea, a leader in identifying and then cloning specific antibodies created naturally by the human immune system to fight various invaders.The company also has an ongoing relationship with the federal Centers for Disease Control and Prevention in Atlanta.

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Pall GeneDisc® Plates for Listeria Testing Granted AOAC Certification

Pall Corporation announced that its GeneDisc® assays for Listeria have received Performance Tested Methods (PTM) Certification from the AOAC Research Institute, one of the world's leading standards organizations. The certification means food companies now have an independently validated, extremely fast and easy-to-use food-borne pathogen detection option to help ensure the safety of their products.

The Centers for Disease Control and Prevention reports around 1,600 U.S. cases of Listeriosis annually. Caused by Listeria monocytogenes, a widely spread bacterial foodborne pathogen, Listeriosis can cause severe illness and even death. Symptoms can include upset stomach and flu-like symptoms such as fever, headache, nausea, and vomiting. U.S. regulatory agencies have a "zero tolerance" policy for Listeria monocytogenes contamination of ready-to-eat food products, requesting recall of such products at any detectable level of Listeria monocytogenes.

Pall's Polymerase Chain Reaction (PCR)-based GeneDisc technology allows multiparametric assays for food-borne pathogen detection. The system and test procedure yields consistently repeatable results and virtually eliminates operator error. A unique real time PCR test, the GeneDisc Listeria identification plate allows food safety laboratories, for the first time, to have Listeria species identification within one hour. Routine biochemical tests typically take 24 hours.

"This Listeria species identification assay enables the food industry to access highly specific and extremely rapid methods for their quality control tasks," stated Jonathan Pratt, President Pall Food and Beverage.

During this independent third-party validation, Pall GeneDisc assays, for Listeria spp and Listeria monocytogenes, as well as the combined assay, Listeria DUO, received AOAC-PTM certification for a variety of foods and environmental surfaces.

"These Listeria certifications represent a major step forward for our food industry partners who can enhance their routine testing for food-borne pathogens," added Jonathan Pratt. "Consider the recent Listeria cantaloupe recall in late 2011. Noted as one of the deadliest U.S. outbreaks of food-related illness in over 10 years, it claimed the lives of 30 people and caused illness in over 100 others. There is a clear need for fast and reliable assays in food-borne pathogen monitoring. Pall continues to work hard to deliver on these expectations."

Pall Food and Beverage is the global leader in filtration, separation and quality assurance solutions for the food and beverage market. It serves the needs of the beer, wine, spirits, dairy, soft drink, bottled water, enzymes, food ingredients and associated industries. Pall's solutions help to ensure product quality and protect consumers while lowering operating costs and minimizing waste.

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FDA Clears Gen-Probe's PANTHER® System for use with APTIMA Combo 2® Assay

Gen-Probe Incorporated announced today that the US Food and Drug Administration (FDA) has cleared its PANTHER system, a fully automated and integrated molecular testing platform designed with the flexibility to handle a wide range of testing needs. The PANTHER system can initially be used to test for the common sexually transmitted infections Chlamydia trachomatis and Neisseria gonorrhoeae with the APTIMA Combo 2 assay.

"FDA clearance of our PANTHER system represents a significant milestone for Gen-Probe," said Carl Hull, Gen-Probe's chairman and chief executive officer. "It is a credit to the scores of talented and dedicated scientists and engineers who made it happen. Just as TIGRIS® revolutionized molecular diagnostic screening with an unparalleled level of throughput and automation, we believe PANTHER will continue that revolution by bringing the power of fully-automated, sample-to-result capabilities to low- and medium-volume labs. This clearance will now allow the Company to significantly increase its addressable market domestically, following on the successful international launch of PANTHER in late 2010. The unique capabilities of future versions of the PANTHER system will provide Gen-Probe with the opportunity to enter new and attractive markets in the future such as viral load testing."

Key features of the PANTHER system include:

Fully integrated "sample-in, results-out" automation. A single operator can process 275 samples in eight hours on the PANTHER system. Hands-on time is less than an hour, yielding seven hours of walk-away freedom per shift. For larger customers, the PANTHER system can continue running unattended, processing up to 500 samples in 12 hours.

Primary tube sampling with random access loading for maximum flexibility and productivity. Multiple assays can be run from a single sample, and operators have continuous access to samples, reagents and consumables.

A customer-driven design, intuitive software for ease of use, and remote diagnostics capabilities.

Extensive process controls including positive sample identification, liquid level detection, reagent dispense verification, and radio frequency identification (RFID) tags on fluid containers providing customers confidence in results.

A small footprint and compact profile with a width of 48 inches, a depth of 32 inches, and a height of 69 inches.

Gen-Probe will begin shipments of PANTHER systems to US customers during the second quarter of 2012. Additional APTIMA women's health assays such as APTIMA® Trichomonas vaginalis and APTIMA® HPV are expected to be added to the PANTHER menu as they progress through the regulatory process, and several other qualitative and quantitative assays are currently in development.

The PANTHER system builds on the success of Gen-Probe's TIGRIS system, which was the first fully automated, high-throughput molecular testing system for large laboratories. Since its launch in 2004, more than 650 TIGRIS systems have been installed at clinical diagnostic and blood screening laboratories around the world.

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Roka Bioscience Atlas™ System Supports Efficient, Innovative Food Pathogen Testing At QC Laboratories

Roka Bioscience announced today adoption of the Atlas System at QC Laboratories, Inc. (QCL) in Horsham, Pennsylvania. QCL, a leading analytical testing laboratory providing services to the environmental, dairy, food and pharmaceutical industries, has implemented the Atlas System along with the Atlas Listeria Detection Assay and the Atlas Salmonella Detection Assay, both of which have received AOAC-RI certification.

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

QCL plans to use the Atlas System as the key component in a new "innovative service offering" for sample testing that will allow greater efficiencies and faster turn-around times.

Mark Carter, CEO of QCL, explained, "This technology provides unique flexibility and workflow capabilities that enable us to explore alternative business models. We are able to provide a rapid turn-around time and improved accuracy to our customers in a cost-effective manner. We will be highlighting the Atlas System in our new 28,000 square foot Life Sciences Facility, in Horsham, Pennsylvania."

"We are so pleased that QCL chose the Atlas System," said Paul Thomas, CEO and President of Roka Bioscience. "Working with QCL to discover the most efficient use of the Atlas System in their organization underscores Roka Bioscience's individualized, customer-centric approach to food safety testing technology. We are excited to continue our partnership and support QCL in realizing the full benefits the Atlas System can bring to their food safety testing."

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Celsis AutoSampler Provides High Capacity Rapid Microbial Screening Solution

The Celsis AutoSampler, a high-throughput, robotic sampling unit for the Celsis Innovate™ rapid microbial screening system for the dairy and beverage industry, is now available globally. By automating the few manual processes used in the Celsis rapid detection process, each AutoSampler enables companies to test up to 500 samples per hour while reducing human error.

"The AutoSampler provides us with a high volume, rapid and efficient testing system for our dairy products," said Dr Johan Roeygens, DC Quality Control of FrieslandCampina. "It not only allows us to meet our customer demands more effectively, as we can release product sooner, but also ensures our product quality and safety. The barcode reader provides a perfect track and trace system for our controlled samples." Dr Roeygens also added, "In addition we have found that the AutoSampler has a lot of flexibility as it is able to run test samples from different packaging designs, including cartons of varying volumes, bottles and coffee milk cups."

The AutoSampler integrates seamlessly with the Innovate luminometer instrument, software and Celsis RapiScreen™ reagents to deliver a rapid microbial system that is rugged and easy to use with unmatched detection sensitivity.

The Innovate system provides manufacturers with microbial test results in as few as 48 hours, compared to 4-14 days with traditional methods, enabling them to release product to market faster as well as shortening production cycles and unlocking huge operational savings.

The AutoSampler, which carries the CE quality mark, can take up to 500 reproducible samples per hour from any pipettable sample size UHT/ESL packaged products. Samples are automatically pipetted into microtiter plates, which are bar coded for fast identification, and then analysed by the Celsis Innovate instrument. Sample data is transferred to the Innovate.im software, which can be fully integrated with local LIMS.

"Dairy, food and beverage manufacturers with high testing volume will appreciate the added speed of the automated sampling unit," said Scott Scdoris, Director of Food & Beverage for Celsis. "It also improves employee productivity by freeing up personnel from repetitive pipetting."

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Conjunctivitis Test Granted CLIA Waiver

An improved version of a first-point-of-care diagnostic test for conjunctivitis (AdenoPlus, Rapid Pathogen Screening [RPS]) has been granted waived status by the FDA under the Clinical Laboratory Improvement Amendments (CLIA).

The CLIA waiver, in addition to the FDA 510(k) clearance previously received, allows the test to be used in the United States. The waiver classifies the test as a low-complexity device, which allows the test to be administered by medical office personnel.

The proprietary test allows for the rapid detection of adenoviral antigens directly from tears obtained from the inside of the lower conjunctiva, according to the company. A nurse or technician can perform the test when a patient presents with a red eye or other symptoms of conjunctivitis. The patient can then be isolated for 10 minutes while awaiting the results.

According to RPS, the improved test has a clinical sensitivity of 90% and a specificity of 96% when compared with cell culture as the reference method. The test’s accuracy allows for the appropriate patient management to begin at the office visit and reduces future unnecessary medical office visits, the cost of unnecessary antibiotic prescriptions, and the need for additional laboratory testing, according to the company.

“The clinical signs and symptoms of adenoviral and bacterial conjunctivitis are nonspecific, making it very challenging to diagnose clinically,” said Robert Sambursky, MD, RPS president and chief medical officer. “[This improved test] provides an accurate adenovirus diagnosis in 10 minutes, positioning this test in the same category with other rapid and routinely used in-office diagnostic tools, such as strep and flu tests.”

RPS anticipates that the test will be available in the United States by early August.

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Nanosphere Enters Into Marketing and Distribution Agreement in Europe With Thermo Fisher Scientific

Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, today announced that it entered into a marketing and distribution agreement with Thermo Fisher Scientific Inc. for markets in Germany, Austria and France. Thermo Fisher, the world leader in serving science, has a broad portfolio of products for microbiological applications.

Nanosphere previously received the CE mark to sell the Verigene® System and a number of assays targeted at the microbiology market segment, a rapidly growing field in which Thermo Fisher has a significant market presence.

"Thermo Fisher's marketing, distribution and customer support expertise combined with the unique ability of Nanosphere's Verigene System to detect multiple targets in a single, automated test creates a significant competitive advantage in building a major presence in these key European markets," said Michael McGarrity, Nanosphere's chief commercial officer.

"The agreement will focus on Verigene products that provide rapid identification of infectious diseases and associated drug resistance, arming physicians and hospitals with clinically actionable results that improve patient care and reduce the cost of treating critical illnesses," commented Paul James, Thermo Fisher's European vice president and general manager for microbiology. "We are excited to be working with the Nanosphere team to bring these innovative molecular diagnostic products to our customers for the first time. Together with our existing range of Thermo Scientific microbiology products, they provide a comprehensive solution to diagnosis of serious infectious disease," concluded James.

With the commencement of this agreement, Nanosphere will possess distribution agreements in all of the major markets in Europe, a key step in its global expansion strategy.

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