Meridian Receives CE Marking for Two New Molecular Tests Targeting Chlamydia and Gonorrhea

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received the CE Mark for two new molecular diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), the sixth and seventh assays on the illumigene® platform. Along with these two new assays, Meridian also received the CE Mark for an innovative, simple, fast and cost effective sample preparation system, M-prep™, that is designed to facilitate the isolation of Chlamydia and Gonorrhoeae from clinical samples. All three products will be distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the Company’s global distribution network.

"Finally, there is a molecular platform in the market place that can decentralize testing that is typically done in core reference laboratories, and can be done so in a cost effective manner,” said Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics. “Meridian expects these two new illumigene tests, along with the innovative M-Prep system, to be introduced to laboratories that haven’t had the opportunity previously to perform molecular testing, or are looking for improvements to their current testing platform. This will allow health-care providers truly to enable collection, testing, and treatment to occur on the same day.”

Chlamydia trachomatis and Neisseria gonorrhoeae are the most common bacterial sexually transmitted infections worldwide. The World Health Organization estimates that 92 million cases of C. trachomatis and 62 million new cases of N. gonorrhoeae infections occur annually. The European Centers for Disease Control and Prevention (ECDC) have reported that chlamydial infections doubled over the last ten years, and the rate of gonorrhea is also on the rise. When detected quickly, both are easy to treat and manage. However, the issue occurs when older technologies are used for diagnosis, increasing time to treatment, causing patients and their partners to be uninformed and untreated.

The illumigene CT & NG assays utilize endocervical swabs, self-collected vaginal swabs, and female and male urine, making collection easy and non-invasive for physicians and patients. The test procedure is universal for all specimen types, and takes less than one hour to report a final result. Unlike other molecular systems, the illumigene platform requires no expensive capital equipment, and no costly annual service contracts. The performance and simplicity of this technology, along with its cost efficiency and small footprint, makes these new assays ideal for enabling a more rapid diagnosis.

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FDA Authorizes Corgenix Ebola Rapid Antigen Test for Emergency Use

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, announced it has received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) of its ReEBOV™ Antigen Rapid Test. The test is to be used for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction and with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection.)

The Corgenix Ebola rapid test is the first rapid diagnostic test (RDT) and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus. The EUA allows the use of the ReEBOV™ Antigen Rapid Test in circumstances when use of a rapid Ebola test is determined to be more appropriate than use of an authorized Ebola nucleic acid (molecular) test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The authorized ReEBOV™ Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing.

Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the Corgenix RDT is a point-of-care test that can be used in any clinical facility adequately equipped, trained and capable of such testing, or in any field laboratory with trained personnel capable of such testing, to diagnose suspected Ebola cases in 15-25 minutes. The U.S. regulatory authorization follows last week’s World Health Organization (WHO) listing for procurement for the Corgenix Ebola RDT, making this test available to the health care community worldwide.

“The FDA and WHO have been working closely with us throughout this process to get this new test in the hands of those battling on the front lines of the Ebola outbreak as quickly as possible,” said Douglass Simpson, Corgenix President and CEO. “Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, non-profits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak. This collaboration has enabled us to quickly deliver this critically important point-of-care test and potential breakthrough in the fight against Ebola in the current outbreak in West Africa.”

Ebola is indigenous to Africa and is one of the deadliest viruses in the world, with mortality rates of between 30 and 90 percent. Ebola and other viral hemorrhagic fevers are difficult to discriminate because many of the early signs and symptoms are nonspecific and common to other infectious diseases such as Dengue fever, Lassa fever, typhoid and malaria.

“Corgenix’s work is crucial to addressing the Ebola outbreak in West Africa,” said United States Senator from Colorado Michael Bennet. “This new test has the potential to help medical officials in the field diagnose Ebola virus disease quicker than before to help control the spread of this vicious disease. We're extremely grateful that this Colorado-based company has invested its resources and completed this research to develop such a valuable tool.”

The ReEBOV™ Antigen Rapid Test was developed by Corgenix in cooperation with additional members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University, including Autoimmune Technologies LLC, Zalgen Labs LLC, The Scripps Research Institute and the University of Texas Medical Branch at Galveston, as well as other collaborators in West Africa. Mr. Simpson noted, "We are pleased to be part of the VHFC. This is a remarkable group of scientists who have been in the forefront of research in Ebola, Lassa fever and other dangerous viral diseases in Africa for many years. A key component of our success is a result of the commitment and participation of the Ministry of Sanitation and Public Health of the Republic of Sierra Leone and the dedicated medical personnel of the Kenema Government Hospital in Kenema, Sierra Leone, a number of whom have died fighting the current Ebola outbreak.”

“This has the potential to be a game-changer in stopping the spread of the epidemic,” said Dr. Robert Garry, Professor of Microbiology and Immunology at Tulane, and Principal Investigator of the VHFC. “Instead of taking days for lab results, the Ebola RDT uses a drop of blood from a finger prick to deliver a diagnosis in as little as 15 – 25 minutes, potentially allowing trained public health workers to isolate and treat patients immediately. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in the current outbreak.”

The FDA’s emergency use authorization of the ReEBOV™ Antigen Rapid Test is for the presumptive detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, including geographic location with high prevalence of Ebola infection. The test was also evaluated under WHO’s Emergency Use Assessment and Listing procedure, which provides independent technical information on safety, quality and performance of in vitro diagnostics, principally to other United Nations (UN) agencies but also to WHO Member States and other interested organizations in the context of the Ebola emergency.

Mr. Simpson stated that the VHFC will remain actively engaged in efforts to advance additional diagnostic products, some already under development for viral and parasitic diseases, and to expand collaborations with global health care partners, including providers in West Africa. The consortium has already developed a suite of additional laboratory assays to complement its RDTs. These additional assays are being developed to permit confirmation of point-of-care test results and augment much needed serosurveillance capabilities via ongoing and future seroprevalence studies on both Ebola and Lassa fever.

Development of the Corgenix ReEBOV™ Antigen Rapid Test for Ebola was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) (grants 1R43AI088843 and 2R44AI088843). Additional support has been provided by The Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.

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Vivione Biosciences Announces Successful Field Deployment of RAPID-B With Greene's Energy

Vivione Biosciences Inc. announced today the successful field deployment of its proprietary bacterial detection platform, RAPID-B with Greene's Energy Group, LLC. Greene's utilized Vivione's RAPID-B system to detect and enumerate bacteria in oil field flow-back water samples before and after anti-microbial treatments were administered. Within 20 minutes of testing, RAPID-B provided Greene's with relevant data on the impact their antimicrobial treatments had on reducing the viable bacteria in the water. The real time data allowed Greene's to immediately optimize their treatment and provide their customer, one of the large independent Energy and Production companies, with a level of service that previous technologies could not provide.

Brandon Faulk of Greene's Energy Group's Water Treatment Services division commented, "The reason we chose Vivione's RAPID-B platform to provide us with additional data is due to the precision their equipment brings to the outdated diagnostic tools in the oil & gas industry when it comes to determining bacterial counts. Vivione's technology has allowed Greene's Water Treatment Services division to determine real time bacterial counts when it is needed most. The data has allowed us to improve and fine tune our water treatment efficiencies while onsite that would not have been possible with previous technologies in the given time frame."

The potential beneficial use of produced waters is an area of expanding interest in the oil and gas exploration and production industry, particularly in areas with limited water resources. Oilfield service companies such as Greene's are charged with the management, filtration and reuse of these waters.

In order to effectively manage and treat oilfield production waters it is necessary to first analyze the water content to determine what treatment modalities are necessary.

"We believe the RAPID-B system gives water treatment companies the best possible tool for determining the effectiveness of a treatment protocol. There are absolutely no competing products in the oil & gas space that can provide this level of rapid information to the producer/service provider," according to Kevin Kuykendall, Vivione's CEO. Kuykendall continued, "The production of oil and gas from unconventional formations has surpassed conventional production in the United States and abroad. In the U.S. alone there are over 700,000 hydraulic fracturing stages annually with numerous water treatments and tests required for every stage. We see this as a great opportunity to expand our market presence outside of Food Safety and Clinical Diagnostics while promoting green chemistry to the industry with the information it needs to foster evidence-based, scientific approaches in the pursuit of more sustainable practices in water management and hydraulic fracturing."

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bioLytical's INSTI HIV Assay Receives FDA Approval for HIV-2

bioLytical Laboratories Inc., a leading manufacturer of point-of-care rapid diagnostic tests, announced today that it has received U.S. Food and Drug Administration (FDA) approval of its INSTI HIV Antibody Test for use in detecting antibodies to HIV type 2 (HIV-2). With this approval, the INSTI HIV-1/2 Antibody Test is available for use in detecting HIV-1 and HIV-2 antibodies in as little as 60 seconds.

Centers for Disease Control and Prevention (CDC) estimates that over 1.2 million persons aged 13 years and older are living with HIV infection in the United States, including over 168,300 (14%) who are unaware of their infection.1 With the ability to expand into more public health bodies and hospital markets, bioLytical will be able to better serve its community through more readily available HIV testing.

The Company is excited to add the HIV-2 claim to its already impressive regulatory approval credentials, including those from Health Canada and the European Union, the World Health Organization (Prequalification) and the U.S. FDA.  INSTI's FDA approval also includes a "CLIA" waiver which allows the test to be administered outside of a laboratory setting by anyone who has been trained in its use - an important consideration in global 'seek and treat' testing initiatives.  Providing HIV testing services in non-clinical venues facilitates access for individuals who may not access these services through other health care providers, those who may be testing for the first time, or those at highest risk of acquiring HIV who would benefit from repeated testing.

Mr. Robert Mackie, Executive Chairman of bioLytical Laboratories, is proud of the many accomplishments the bioLytical team has achieved as the Company surpasses yet another major milestone.  "We are expanding our sales force in multiple U.S. markets to support our revenue growth model and to continue to provide best in class service to our customers.  The FDA approved and "CLIA" waived INSTI HIV-1/2 test will allow bioLytical to further successfully penetrate the U.S. market to increase market share."

"INSTI was developed for the detection of antibodies to both HIV types and so the FDA approved HIV-2 claim will allow bioLytical to expand its markets further in the United States as some health departments require it for their testing programs.  We are thrilled to have obtained the HIV-2 designation," said Rick Galli, Chief Technical Officer of bioLytical Laboratories.

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MRIGlobal Wins Contract To Develop Whole Genome Sequencing Diagnostic System

MRIGlobal today announced that it has been awarded a $14.8 million contract to develop an end-to-end next generation sequencing system for clinical diagnosis of infectious diseases.

MRIGlobal's proposed Sample-to-Sequence system will take clinical samples (blood or saliva for example) and generate high-quality whole genome sequences of bacteria and viruses. The diagnostic tool will be able to identify a broad range of human pathogens from a single sample with particular emphasis on emerging pathogens and those not identifiable by available rapid diagnostic methods.

With the Sample-to-Sequence system a clinician will send a single sample to a laboratory for sequencing. The genomes uncovered in the sample will be identified against a developed database of microorganisms capable of causing infectious diseases.

"This is a revolutionary approach" said Thomas M. Sack Ph.D. President and Chief Executive Officer of MRIGlobal. "Today each test requires a unique sample and certain procedures such as blood cultures can take a week to generate data. Sample-to-Sequence will provide rapid answers within 24 hours giving actionable data to improve diagnoses and lead to better public health outcomes."

The three-year contract was awarded by the Defense Threat Reduction Agency. The program will generate clinical data that will be used to apply for FDA approval and ultimate release to the commercial market.

MRIGlobal will provide analysis of technology and selection of key components addressing sample preparation next-generation sequencing and bioinformatics. MRIGlobal will lead the systems engineering and integration and testing in preparation for regulatory reviews and the post-contract commercialization of the system.

"MRIGlobal will integrate a diverse team of experts from leading commercial and government entities in this development" said Michael Cassler Ph.D. Director of MRIGlobal Molecular Diagnostics. "We will deploy a 'Gold Standard' pathogen database to generate diagnostic calls as well as draft genomes and antibiotic resistant profiles from the samples."

"The ultimate goal is a new tool that clinicians worldwide can use to quickly and accurately identify deadly infectious disease-causing microorganisms allowing for more rapid and accurate treatment to ultimately save lives" Cassler said.

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bioLytical's INSTI HIV/Syphilis Multiplex Test Cleared for European Market

bioLytical Laboratories Inc., a leading manufacturer of rapid point-of-care diagnostic tests, announced today that its INSTI™ HIV/Syphilis Multiplex Test has been cleared for immediate market entry in the European Union through its Notified Body.  With this approval, the INSTI™ HIV/Syphilis Multiplex Test is available for simultaneous detection of Syphilis, HIV-1 and HIV-2 antibodies in as little as 60 seconds.

The Company is excited to add the INSTI Multiplex assay to its catalogue and to work closely with its distributors to launch the new product.  The assay has been added to its existing CE certificates and is now listed alongside the INSTI HIV-1/2 Antibody Test as an approved device under Annex II List A of the European Council Directive 98/79 EC.  This validation is critical because it confirms the preservation of the CE-Marked INSTI HIV assay performance characteristics combined with an accurate syphilis antibody assay on the same device.

According to the Centers for Disease Control and Prevention, individuals with a sexually transmitted infection (STI) are more likely to get HIV than those who are STI-free1 and co-infection of HIV and syphilis is a growing global concern.  By providing screening for both infections simultaneously on one device in 60 seconds, the INSTI Multiplex assay offers a powerful tool for identifying individuals who need HIV and/or syphilis treatment, preventing mother-to-child transmission, and reducing the spread of both infections worldwide.

bioLytical's INSTI platform is unique because it allows for instant interpretation, while most rapid HIV and syphilis tests take about 20 minutes each to deliver results.  By eliminating the time barrier, INSTI increases access to HIV testing at healthcare sites and creates new opportunities to test in novel settings. This is especially important among individuals who may not access these services through other avenues, those being tested for the first time, and those at highest risk of acquiring HIV who would benefit from repeated testing.

"We are extremely pleased to have received clearance to market the INSTI Multiplex assay in Europe," said Mr. Robert Mackie, Executive Chairman of bioLytical Laboratories.  "This validation provides a vehicle for better servicing the testing community and allows us to aggressively pursue our distributor expansion strategy across Europe."

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Denver Health and Accelerate Diagnostics Awarded $5MM To Study Antibiotic Resistant "Super Bug"

The National Institutes of Health awarded a five year, $5 million grant to Denver Health Medical Center and Accelerate Diagnostics to develop a fast and reliable test to detect common bacteria directly from blood, with corresponding antibiotic susceptibility, in less than three hours. This study 1 will focus on the detection of an antibiotic resistant "Super Bug" known as carbepenem-resistant Enterobacteriaceae (CRE).

The challenge physicians currently face in diagnosing infections caused by bacteria is that testing requires a sample to be sent to a lab and allowed to grow before enough information is available to determine which antibiotics will kill the bacteria. This process typically takes two to three days and while waiting, the physician needs to make a best guess on which antibiotics will treat the infection during the waiting period, which may or may not make a difference. Most of the time, resistant bacteria such as CRE do not respond to the antibiotics used before the diagnosis is made, leading to worse results for the patient. In addition, the excess antibiotics used during the waiting period can breed more resistant bacteria.

The study proposes the use of Accelerate Diagnostics' new technology by which a single bacteria cells can be extracted from the patient's blood, observed under a microscope and identified within a few hours. Different antibiotics or combinations of antibiotics can be tested until the proper combination is reached.

"Accurate and timely detection would allow physicians to make better treatment choices and informed infection prevention measures to prevent further spread of the infection," said Dr. Connie Price, Chief of Infectious Disease at Denver Health and one of the principal investigators in the study. "That, in turn, would prevent the need for more antibiotic use --- which is needed to stop feeding the vicious cycle of antimicrobial resistance."

The new technology being used in the study is called the Accelerate ID/AST System and it combines rapid genomic identification and high speed phenotypic susceptibility system into one instrument.

"We are delighted to be working with Denver Health on further enhancing the capabilities of our revolutionary technology," said Steve Metzger, Head of Product Innovation at Accelerate Diagnostics. "We are especially motivated to focus our attention on CRE, as these pathogens are becoming more difficult to treat."

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Abbott Pathogen Detection Platform Compares Well to PCR-based Gold Standards for Influenza A/B

A pan-pathogen molecular testing platform from Abbott has shown comparable sensitivity in detecting influenza A and B virus as two RT-PCR-based tests, according to a prospective analysis published online last week in the Journal of Virological Methods.

Researchers at Johns Hopkins School of Medicine examined 286 nasopharyngeal swabs collected from people who presented to an urban emergency room with flu-like symptoms during the 2012-2013 flu season.

The study compared the Respiratory Virus Surveillance (RVS) kit 2.5 on Abbott's reverse transcription PCR electro-spray ionization mass spectrometry, or RT-PCR/ESI-MS platform to two US Food and Drug Administration-cleared real-time PCR-based assays, Cepheid's Xpert Flu and Hologic's Prodesse ProFlu+.

The group had previously validated the Cepheid Xpert Flu platform using this data set, concluding that a fast test which does not require batch processing could be a boon to clinicians wishing to follow US Centers for Disease Control and Prevention antiviral prescribing guidelines.

While the Cepheid test has the advantage of being faster than traditional PCR, the Abbott RT-PCR/ESI-MS can provide genotype information and detect other pathogens.

"I like to think of it as a very nice intermediary platform between multiple type-specific assays where you have some a priori knowledge of the agent that you're looking for versus doing sequencing," Justin Hardick, first author on the study and research projects lab manager in Johns Hopkins' Division of Infectious Diseases, told GenomeWeb in an interview.

Hardick said the group previously compared the RT-PCR/ESI-MS technology to other gold standards, such as viral culture, and it usually performs favorably.

In the current study, the researchers calculated the sensitivity and specificity of the RVS kit relative to ProFlu+ alone as the gold standard, and to a combined Xpert Flu and ProFlu+ as the gold standard.

Using a combined gold standard is fairly common practice in these kinds of evaluations, Hardick said. "It helps whenever the two diagnostic tests that you're using as gold-standard methods don't agree. You would use a combined gold standard to focus only on the samples where both of those tests were in agreement," he said.

Using the combined gold standard led to a slight increase in sensitivity in influenza A detection — from 82 to 85 percent — while sensitivity for influenza B, and specificity of the assay for both viruses, remained maxed out between 99 and 100 percent.

One caveat Hardick noted was the small number of positives in the prospective sample set — 27 influenza A cases and 14 influenza B cases tested positive with both gold standard methods — although this was "in line with what you would expect to see in terms of the incidence of influenza in this part of the country for that particular season," he said.

Overall, the researchers concluded that the RVS kit on the Abbott platform "compared favorably" to the gold standards.

Importantly, the RT-PCR/ESI-MS method also provided basic genotype information about the viruses, revealing that all of the influenza A samples were H3N2, and 88 percent of the influenza B was Yamagata strain. The RVS kit was also able to identify additional respiratory viruses in 24 patients.

The RT-PCR/ESI-MS technology was developed by Ibis Biosciences, which was acquired by Abbott in 2009. Previously, an RT-PCR/ESI-MS system was marketed by the firm as Plex-ID, but the next generation of the Abbott platform, Iridica, recently launched and received CE marking late last year.

RT-PCR/ESI-MS amplifies targets that map to shared sequences of a huge range of pathogens. The system then uses mass spectroscopy to identify which pathogens are present. As such, it theoretically acts more like a general survey of which viruses, bacteria, or fungi might be present in a sample. Ibis Biosciences continues to maintain and expand the pathogen database, and Iridica is currently able to detect and differentiate 600 bacterial families, as well as 200 families of fungi and 13 families of virus, as previously reported by GenomeWeb.

The assay used in the JVM study, however, was a more targeted survey from Abbott. The RVS 2.5 kit is designed to detect Influenza A and B viruses, respiratory syncytial virus, coronaviruses, adenoviruses, metapneumovirus, and parainfluenza virus.

Many major diagnostics firms have entered the molecular influenza testing arena, as previously reported by GenomeWeb. Some of these assays boast advantages in time to result, or level of expertise required to perform the test. However, test choice may depend on research goals and project focus, Hardick said, noting that the RT-PCR/ESI-MS test is research use only and is not used in the clinic.

Abbott has not disclosed any plans to pursue US regulatory clearance for the platform, although it has released preliminary data from its Rapid Diagnosis of Infections in the Critically Ill, or RADICAL, study, which suggested the platform could reduce healthcare costs and length of hospital stays.

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PositiveID Corporation Achieves Firefly Dx Development Milestone With Completion of Breadboard PCR

PositiveID Corporation, a developer of biological detection and diagnostics solutions, today announced that it has achieved a significant milestone in the development of its handheld Firefly Dx system with the completion of the build of its breadboard PCR (polymerase chain reaction) chip. The Company has begun testing assays to prove the design of achieving PCR results in less than 20 minutes at standard laboratory volumes, compared to existing technologies which require lab-based equipment and can take hours or days to provide results. The Company plans to announce the results of its testing as it is completed over the next several months.

PositiveID will run rapid thermal cycling with 40 PCR cycles of heating and cooling. Because the Firefly Dx system uses industry-standard 25 – 30 uL reaction volumes, the Company expects that existing FDA-cleared real-time PCR assays can be ported to the system rapidly, reducing development time and expense.  As PositiveID's engineering and biology teams complete their evaluation of the updated sample preparation and PCR design to be integrated into the final iteration of the Firefly Dx cartridge, the Company will also complete optimization of the lyophilized PCR reagents with its reagent supplier. Once validation is complete, the designs will be integrated into an injection molded disposable cartridge, which will be evaluated and optimized to run automatically on the breadboard Firefly Dx platform.

"Completion of the breadboard PCR element of Firefly is a major accomplishment as it carries the highest risk of the development process," stated William J. Caragol, Chairman and CEO of PositiveID. "We are confident in our design, and our next objective is to prove we can deliver real-time PCR results at standard volumes in minutes, which, we believe, would be groundbreaking in the multi-billion dollar real-time PCR market."

PositiveID is developing Firefly Dx based on intellectual property and know-how gained during years of development and $30 million of contract funding from the U.S. Department of Homeland Security for the Company's M-BAND system, which uses PCR for the identification of airborne bio-threats. The Company has miniaturized its proven real-time PCR technology for the handheld Firefly Dx system, which is designed for use by first response teams to detect biological agents associated with weapons of mass destruction; agricultural screening in domestic sectors and developing countries; and point-of-need monitoring of pathogenic outbreaks.

The Firefly Dx instrument will combine sample lysis, purification, real-time PCR analysis, electronic reporting of results, and automated chain of custody with the embedded RFID chip in disposable cartridges. The system is designed to automatically process and purify nucleic acids from diverse sample types, which are then analyzed with the incorporated multiplex PCR assay for multiple user-defined targets. Results can be immediately obtained and processed in-situ via SMART phone interface (or personal computer) with a specialized, mobile HTML application and Cloud-based data sharing and storage. The ease-of-use, portability, low cost, and assay flexibility is designed to provide the user with confidence and assurance of an analytically accurate response in limited and remote environments.

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3M Petrifilm Rapid Yeast and Mold Plate Gains AOAC-OMA Validation

3M Food Safety announced that its 3M™ Petrifilm™ Rapid Yeast and Mold Count Plate has been validated by AOAC INTERNATIONAL as a First Action Official Method of AnalysisSM (OMA method number 2014.05) for the detection of yeasts and molds within food products in as little as 48 hours.

AOAC facilitates consensus and technical standards for the analytical science communities. Food processor, university, government and contract testing laboratories around the world rely on AOAC-OMA validation rigor when choosing chemical, microbial and molecular biological testing methods. To be approved as an Official Method, tests are scrutinized by multiple, independent laboratories and subsequently reviewed by an Expert Review Panel. The full study conducted for the AOAC-OMA validation of the 3M Petrifilm Rapid Yeast and Mold Plate will be published in an upcoming edition of the Journal of AOAC INTERNATIONAL.

3M introduced the plate in September 2013 as a faster and superior indicator test alternative to conventional agar methods. The test is capable of incubating yeast and mold for easier quantification and interpretation in just 48 hours versus five to seven days, as with other methods. It also mitigates the erratic spreading of molds to facilitate clearer and more accurate colony counting.

“Yeast and mold testing has been a labor intensive, time consuming challenge for food producers for years, as they’ve often been forced to hold their finished goods until this final aspect of release testing is completed,” said Jason Semerad, global marketing manager, 3M Food Safety. “This latest validation demonstrates 3M’s continued commitment to providing fast, reliable, and accurate indicator tests that meet the most stringent industry requirements and gives our global customers additional confidence in using our new technology to support faster product release decisions, longer shelf lives and reduced inventory holding costs.”

The 3M Petrifilm Rapid Yeast and Mold Count Plate is part of a large portfolio of 3M™ Petrifilm™ Plate test technologies that has collectively become a worldwide standard due to its hallmark reliability, accuracy and simplicity in incubating, interpreting and enumerating growth colonies. The technology, especially useful for processors of grain, fruit/vegetables, ingredients and dairy products where yeast and mold control is crucial, has been rigorously tested to perform well on both low and high water activity foods.

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DuPont BAX System Real-Time PCR Assay for Listeria Monocytogenes Earns AOAC Certification

The DuPont™ BAX® System Real-Time PCR Assay for Listeria monocytogenes has been certified as a Performance Tested Method by the AOAC Research Institute. This next-generation test––which combines shorter, simpler sample preparation and faster real-time processing without sacrificing accuracy or reliability––has been validated on a variety of sample matrices, including frankfurters, cooked shrimp, spinach, queso fresco and environmental surfaces.

In addition to the 24LEB- and reference method media-based enrichment protocols published during the commercialization of the BAX® System assay in July 2014, this AOAC certification includes a new combined testing method from environmental samples developed by DuPont Nutrition & Health and FoodChek™ Systems Inc. of Calgary, Alberta, Canada. This new combined testing method includes a 20-hour, single-stage enrichment in FoodChek’s proprietary Actero™ Listeria Enrichment Media followed by rapid real-time processing with the DuPont™ BAX® System. The method allows for the detection of L. monocytogenes from environmental samples in about 22 hours, one of the fastest time-to-results available for the pathogen in the food safety industry today.

“The additional time savings of approximately four hours associated with using the BAX® System real-time PCR assay for L. monocytogenes and Actero™ Listeria Enrichment Media together provides benefits to end users that can ripple through the manufacturing process, including reduced labor costs and faster product releases,” says Shannon Bullard, diagnostics global product manager, DuPont Nutrition & Health. “As a market-driven science company, we are proud to work regularly with customers and industry partners like FoodChek to create food safety solutions at both the local and global level.”

“This 22-hour combined Listeria test developed by DuPont Nutrition & Health and FoodChek provides increased value to testing laboratories and food processors alike,” says William J. Hogan, president and CEO of FoodChek. “This can result in superior production workflow, additional product shelf life and an improved financial bottom line.”

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Visual Colour Change Verifies Salmonella Sampling Procedure from Hygiena

The latest addition to the Hygiena line of rapid micro-organism tests is InSite Salmonella, which is a rapid and convenient colorimetric Salmonella species test for environmental surfaces. Its all-in-one test format contains both the pre-enrichment and selective enrichment procedures, maintains security and minimises the risk of cross contamination. It also retains the active culture for any subsequent verification and identification tests.

InSite Salmonella is a self-contained, ready-to-use swab test which contains a specialised liquid medium which changes colour when Salmonella species are present in the sample. A colour change from purple to bright yellow indicates presence, with positive results in as early as 24 hours from sample collection. A short pre-enrichment period of 6 hours gives the optimum and earliest detection of presumptive positive samples in the 24 hour period. Optional overnight or 24 hour pre-enrichment enables detection of such samples in 48 hours. The all-in-one test device eliminates the need for sample preparation materials, saving material and labour costs.

Other environmental Salmonella species test kits require several complicated steps including measurement and mixing of media, sample enrichment, and transfer of enriched sample to the test device. InSite Salmonella’s convenient design eliminates the need for any special preparation, measurement, or enrichment outside the test device, simplifying the assay so any level of user can successfully run the test, thus virtually eliminating the possibility of operator error.

The incorporation of a large foam swab bud improves sample collection, while enabling the coverage of a large surface area for environmental surface testing. The neutralising non-selective pre-enrichment broth utilised enables detection for even low numbers of Salmonella. It also minimises the effect of residual sanitisers while also facilitating the recovery of stressed cells. InSite provides a proven performance for the detection of Salmonella, but with little interference from non-Salmonella bacteria.

Environmental pathogen screening, such as with InSite Salmonella, is a critical element of a comprehensive environmental monitoring program for certain food manufacturers. Not only does environmental monitoring verify a sanitation procedure is effective, it is also part of a well-designed preventive control verification program. The US Food and Drug Administration’s proposed rule for preventive controls in the Food Safety Modernisation Act suggests emphasis on environmental pathogen monitoring for food processors with significant contamination risk. Accordingly, InSite Salmonella meets the needs of food processors for a rapid, convenient, and affordable environmental pathogen screening test kit.

InSite Salmonella joins Hygiena’s line of rapid microorganism tests, including those for Total Viable Count, Listeria species, Enterobacteriaceae, Coliform, and E. coli. Other products from Hygiena include the world’s best-selling ATP monitoring systems and convenient allergen prevention test kits.

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Biocartis to Develop Rapid Ebola Virus Triage Test

Biocartis announced that it is in the testing phase of a Rapid Ebola Virus Triage Test that it is developing in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp (Belgium) for its Idylla system, a fully automated molecular diagnostic platform that is CE-IVD marked in Europe.

The Rapid Ebola Virus Triage Test is designed to enable healthcare workers, even in challenging environments, to test blood samples and aims at providing accurate and fast diagnosis of Ebola. The test is designed to offer a unique combination of speed, sensitivity, accuracy and ease-of- use required for outbreaks where time is of the Essence.

The test uses 0,2 ml blood that is added directly to the Idylla cartridge, which contains all necessary reagents on board for performing the analysis on Biocartis fully automated, molecular diagnostics system. A complete analysis of the sample takes around 90 minutes and can be operated by healthcare professional in most settings, including in the field, making the test ideal for use in regions with limited Infrastructure.

Biocartis believes its Rapid Ebola Virus Triage Test could provide a sustainable solution for rapid detection of Ebola-infected patients even after the current Ebola outbreak. After testing of synthetic virus samples in Belgium and the US, Biocartis has now registered for field-testing in West Africa to gather additional clinical evidence for the test Performance.

Rudi Pauwels, Biocartis chief executive officer commented: This test aims not only to improve the diagnosis of the Ebola virus for hard-pressed healthcare professionals in the field, but to lay the foundations for a better and faster diagnostic infrastructure after the current outbreak has receded, both in this region and around the world. One of the lessons of the Ebola outbreak has been the urgent need for faster and more accurate diagnostics. Biocartis is pleased to be working, alongside prestigious partners, on what it believes could offer a viable solution for healthcare workers around the world to enable faster testing of infectious diseases in virtually any setting.

The Idylla platform, launched as a CE-marked product in September 2014, is a fully- automated, self-contained real-time polymerase chain reaction based MDx system, designed to offer physicians fast access to highly reliable MDx information. The Idylla platform is differentiated by its ability to perform tests on-demand in virtually any setting, from any biological sample type without the need for pre-processing, and its capacity to detect multiple biomarkers from a single sample. The Idylla platform covers the entire process from sample to result in 35 to 150 minutes (depending on the type of assay), with a hands-on time of around two minutes.

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German Drugmaker Stada Launches Device-Independent Rapid Test for the Detection of Ebola Infections

From March 2015, STADApharm GmbH will take over global sales of a device-independent Ebola rapid test, thereby adding another field of application to the STADA Diagnostik product line. The new rapid test detects an advanced-stage Ebola infection within minutes and is intended exclusively for use by medical professionals. Responsibility for the development and production lies with Senova, a bio-science and technology company located in Weimar, which specializes in immunological rapid tests.

"With our high-quality screening test, infected persons can be detected within a very short space of time, isolated from their environment and further diagnostic steps can be initiated. This speeds up and simplifies the quarantine management in the disaster areas," explains Lothar Guske, Managing Director of STADApharm. The Ebola rapid test from STADA Diagnostik is based on the proven lateral flow principle and works independently of a power supply. Serum, which can be obtained from a mechanically treated blood sample for example, can be used among other things as a sample material for detecting the highly virulent pathogen.

To carry out the analysis, the sample simply needs to be applied to the test system. Information on the presence of an advanced stage Ebola infection is then provided through the detection of an antigen. Senova has validated the reliability of the test using several hundred real specimens in Guinea. For Senova owner Hans Hermann Söffing, a key area of application for the rapid test is the examination of Ebola victims who have passed away: "The viral load in people who have died of Ebola is so high that even a mere throat swab is sufficient to perform the rapid test. Isolation can thus be carried out extremely quickly in the event of a positive test result. This is particularly important as experience shows that in the main infection areas, many people become infected through contact with the deceased.''

This is the first time that STADA has worked with Senova. Since it was founded in 1999, the company from Weimar, Germany, has introduced a variety of immunological tests to the market. "As with all other tests from our STADA Diagnostik product family, we were specifically looking for a competent partner to develop our portfolio with. We are therefore very pleased to be working with Senova: our areas of expertise perfectly complement one another and together we can now offer the aid organizations and community teams in the Ebola areas a rapid test, which detects infection faster than previously possible, thus contributing to the further containment of the Ebola epidemic," says Guske.

The test kits contain all of the necessary materials for use as well instruction manuals in German, English and French. Doctors, hospitals and aid organizations can order the Ebola rapid test from STADA directly or from pharmaceutical wholesalers. The price per test is € 3,20 net.

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Celsis Introduces the All New Celsis Accel™ Rapid Microbial Screening System for Small and Medium-Size Manufacturing Companies

Celsis, the global leader in rapid microbial testing systems for industry, today introduced the Celsis Accel system, the most robust and easiest-to-use rapid microbial screening system for small and medium-size manufacturing companies.

Utilizing Celsis’ proprietary reagent technology, the Celsis Accel system reduces time necessary for quality control assessment of microbial contamination. This shortens production cycle times by lowering quarantined inventory levels awaiting quality control release and reduces working capital requirements. Faster quality control results also provide an earlier indication of contamination allowing a faster and more effective investigation and corrective action, thereby reducing the economic impact of the event.

Using its Financial Impact Assessment (FIA), Celsis works with hundreds of manufacturing facilities around the world to evaluate the cost savings of implementing a Celsis system. Utilizing company specific information including the value of products and the time and cost comparisons associated with the Celsis method, the FIA projects the 5-year Net Present Value (NPV) of a company’s investment in the Celsis system. The 5-year NPV for the average manufacturing facility is typically in excess of $300,000.

The Celsis Accel takes the robustness and ease-of-use of the widely adopted Celsis Advance platform packaged into a compact system specifically designed for small and medium-size manufacturing facilities. Easy-to-use, easy-to-learn software makes the Celsis Accel a great fit for Home, Beauty and Pharmaceutical product manufacturers’ busy microbiology labs.

“Celsis works with product manufacturers of all sizes. Small and medium-size manufacturers have different testing requirements than large manufacturers and were asking for an instrument designed to meet their needs,” said Jay LeCoque, CEO. “Responding to this demand, we developed the Accel for manufacturers whose testing requirements are smaller, but we employed the same robustness and ease-of-use of our popular large capacity Advance platform.”

To allow maximum flexibility with sample size and sensitivity, Celsis adapted the familiar sample tube platform to a precision movement carousel for easy loading and speedy processing with the ability to run 30 assays at a time. A fourth injector position gives the system flexibility to use new reagent technologies as they are developed. From reagent bottle access to sample loading, the ergonomic design puts everything easily at the fingertips of the user.

Celsis Accel.im™ takes advantage of current Celsis software innovations, such as a new ribbon menu system, data security features, and the ability to export sample results. User administration features, an event log and more allow users full compliance with the FDA’s CFR 21 Part 11 and the EU’s Annex 11.

Proven rugged and reliable systems, plus dedicated global support, have made Celsis the industry standard for leading manufacturers around the world. Celsis systems are used to rapidly and effectively screen a variety of Home, Beauty and Pharmaceutical products — including body washes, lotions, soaps, toothpastes, liquid detergents, cosmetics, tablets and ointments, IV solutions and oral drug suspensions — helping companies save time and money while releasing safe products to market.

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Hyderabad University Gets President's Award for Rapid TB Test

Hyderabad University was today given the first President's award for the best university for academic excellence and overall outstanding work.

The award, which carries a citation and a trophy, was given by President Pranab Mukherjee to Hyderabad University's Vice Chancellor Prof E Haribabu during a ceremony at Rashtrapati Bhavan's Durbar Hall.

The Hyderabad University, which was established in October 1974, is a premier institution of post graduate teaching and research in the country. It has National Assessment and Accreditation Council (NAAC) rating of 3.72 on a scale of four.          

Two Delhi University teachers -- Vijay K Chaudhary and Amita Gupta -- have also been awarded Visitor's award for innovation for carrying out unique research that led to a product 'TB Confirm' for rapid diagnostic test for deadly Tuberculosis disease.        

Chaudhary is a Professor and head at the Delhi University's Department of Biochemistry and Gupta is working as Associate Professor in the same department.      

They have developed a novel immunochromatography-based assay for the rapid identification of Mycobacterium Tuberoculosis (MTB) from culture, according to the detail mentioned in the presentation ceremony.  

The assay has been licensed to Span Diagnostics Ltd, Surat. In addition, an Indian patent is filed for it and approval of Drug Controller General of India (DCGI) has been obtained for commercial diagnostic use of the assay.    

The test, developed by the duo, reduces the time of TB confirmation in culture from several days to less than 20 minutes and maintains highest standards of accurate diagnosis, it said.

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Nuclea Biotechnologies Partners with BacterioScan on New Instrument

Nuclea Biotechnologies Inc. announced that it is partnering with BacterioScan inc. of St. Louis, to do the validation testing of its BacterioScan 216Dx instrument in a CLIA certified laboratory.

This collaboration will focus on antimicrobial susceptibility testing to guide the best course of antibiotic treatment for different strains of urinary tract infections.

BacterioScan focuses on the rapid detection and real-time quantification of bacteria in fluid using optical measurements. BacterioScan represents a new frontier in microbial lab technology that enables researchers to quantify bacterial concentration and growth in a liquid in under twenty minutes. Nuclea Biotechnologies Inc. headquartered in Pittsfield, Massachusetts, is developing and commercializing molecular oncology and metabolic syndrome diagnostics, with a recent expansion into infectious diseases.

The BacterioScan 216D can be used to detect and quantify bacterial concentrations that would typically fall below the detection limits of spectrophotometers.

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Fujifilm, French Institute To Develop Ebola Diagnostic System

Fujifilm Holdings Corp. say it has reached an agreement with French public research institute Bioaster to jointly develop a rapid diagnostic system for the Ebola virus.

The aim is to establish a diagnostic system capable of detecting Ebola infections in as short as about 15 minutes, Japan's Jiji Press news agency reported.

At present, only large research centres and hospitals are properly equipped to diagnose Ebola.

Fujifilm aims to develop the system by the end of the year.

The company is contributing technology it has traditionally used in photos' development process.

The same technology was used to develop an influenza diagnosis system that can detect the virus in three to 15 minutes. The system is now used at hospitals all over Japan.

The French institute will provide the Ebola antibodies.

If the new technology works, Ebola detection will be possible in about 15 to 30 minutes through a simple test on a portable device.

In order to contain the disease, it is important to identify infections in their early stages and break the chain of infection as well as develop vaccines and drugs.

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Reference Genomics Wins CDC Award to Develop STEC Identification Method

Startup bioinformatics firm Reference Genomics has won the US Centers for Disease Control and Prevention's $200,000 "No-Petri-Dish" Challenge, the company said on Monday.

The challenge called for contestants to develop a rapid "straight-to-strain" method for identifying Shiga toxin-producing E. coli, a common cause of severe foodborne outbreaks. Using next-generation sequencing data, Reference Genomics' method provides fast, high-resolution diagnostics results and can be used for metagenomic samples with "extremely low concentrations of E. coli or other pathogens," it said.

Current methods of detecting STEC include culture-based approaches, which can take days or weeks to get results, and PCR-based tests, which can provide results more quickly but are less informative, said Reference Genomics, which also goes by the name of its platform called One Codex.

"The developers of One Codex succeeded in demonstrating how their platform can rapidly identify STEC from complex clinical samples and provide meaningful information about its strain-type and characteristics, even when the pathogens are present at levels too low to support assembly-based methods," CDC said in a statement. The "No-Petri-Dish Challenge is part of the center's Advanced Molecular Detection initiative.

The One Codex platform is currently in beta mode, and San Francisco-based Reference Genomics is "building the largest index of genomic data and better search algorithms for fast, accurate bacterial and viral identification," it said.

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3M Molecular Detection Assays Listeria monocytogenes and Listeria Receive First Action Official Methods of Analysis Designations by AOAC

3M Food Safety announced that two of its 3M™ Molecular Detection Assays, Listeria monocytogenes and Listeria species, have been approved for First Action Official Method of Analysis SM distinction by AOAC INTERNATIONAL (OMA method numbers 2014.07 and 2014.06, respectively). The scope of the validations cover a variety of food matrices including full fat cottage cheese, chocolate milk, beef hot dogs, deli turkey, and cold smoked salmon, as well as stainless steel and concrete environmental surfaces. The assays provide rapid results after as little as 24 hours of enrichment – days faster than the standard methods.

The Official Methods of Analysis, AOAC INTERNATIONAL’s premier, internationally recognized program for chemical, microbial and molecular biological testing methods, consists of a multi-laboratory validation of the method, and review by an expert panel. A complete review of the studies conducted for these validations will be published by the Official Methods of Analysis of AOAC INTERNATIONAL, online at http://eoma.aoac.org/ and in an upcoming edition of its Journal of AOAC INTERNATIONAL.

The 3M™ Molecular Detection System, first introduced to food processors, third-party reference laboratories and other customers in 2011, is based on unique isothermal DNA amplification and bioluminescence detection technologies. The rapid, qualitative technology is applied to enriched food as well as food process environmental samples. It is designed around modern-day food processors’ needs for a real-time pathogen detection approach that’s faster and simpler while also more accurate.

“The AOAC Official Methods of Analysis carry a reputation for the highest standards of excellence and rigorous analysis, and we are proud that our assays are recognized by this globally-recognized agency,” said John David, global marketing supervisor with 3M Food Safety. “These validations further demonstrate 3M’s commitment to providing simple, rapid solutions that improve lab productivity while offering superior results.”

For its 3M Molecular Detection System, 3M also has AOAC INTERNATIONAL First Action Official Methods of Analysis status for its 3M Molecular Detection Assay Salmonella and both AOAC PTM and NF VALIDATION by AFNOR Certification for its 3M Molecular Detection Assay Salmonella and 3M Molecular Detection Assay E.coli O157 (including H7), in addition to certifications from government and regulatory organizations in other countries around the world.

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Chembio Awarded Grant to Develop Next-Generation Point-of-Care Diagnostic Test for Malaria

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests for infectious diseases, has been awarded a grant from the Bill & Melinda Gates Foundation to expedite the feasibility testing and development of a DPP® Malaria POC rapid diagnostic to accurately identify individuals infected with Plasmodium falciparum parasite.

Chembio's DPP® technology has been selected for this grant due to its exceptional sensitivity and potential to aid the foundation in its goal of eradicating malaria. To achieve this goal, diagnostics must be capable of detecting the malaria parasite in infected, but asymptomatic people. Current POC rapid diagnostics tests lack sufficient sensitivity to identify all individuals with transmissible infections.

Javan Esfandiari, Chembio's Chief Science & Technology Officer and the principal investigator of this project, commented, "We are honored that our patented DPP® technology will be one of those selected by the Gates Foundation to be tested for such an important endeavor. We believe our DPP® technology provides the platform to develop a more sensitive POC malaria test capable of identifying individuals with low parasite densities who contribute to transmission."

John Sperzel, Chembio's Chief Executive Officer, commented, "Through this grant, Chembio is reaffirming our role as a leader in the early and rapid diagnosis of infectious disease, and our commitment to improving public health worldwide. The grant from the foundation comes just weeks after Chembio entered into a research collaboration agreement with the Centers for Disease Control & Prevention (CDC), to develop and validate DPP® Ebola and DPP® Febrile Illness Assays, which include Ebola and malaria. We have made quick progress with the CDC program and we are already on track to provide the CDC with DPP® Ebola and DPP® Febrile Illness Assays during the first quarter of 2015 for initial field testing in West Africa. It is our hope that we can rapidly establish feasibility and be selected to proceed with product development for the Gates Foundation, as well."

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Made-in-Singapore Rapid Test Kit Detects Dengue Antibodies from Saliva

Finding out whether you have been infected with dengue may soon be as easy as spitting into a rapid test kit. The Institute of Bioengineering and Nanotechnology (IBN) of A*STAR has developed a paper-based disposable device that will allow dengue-specific antibodies to be detected easily from saliva within 20 minutes. This device is currently undergoing further development for commercialization.

IBN Executive Director Professor Jackie Y. Ying shared, “Our rapid diagnostic kit can detect a key dengue antibody from saliva that is present in early-stage secondary infection. The ability to differentiate between primary and secondary dengue infections makes it a valuable early diagnosis tool that would help to ensure timely treatment and proper care of patients.”

Patients with secondary infection, who have previously been infected with other serotypes of dengue virus, stand a higher risk of developing dengue hemorrhagic fever or dengue shock syndrome.

According to Singapore’s National Environment Agency, dengue fever and its more severe form, dengue hemorrhagic fever, are the most common mosquito-borne viral diseases in the world. This disease poses a serious health threat, and is a leading cause of illness and death in tropical and subtropical climates. There are four known serotypes of the dengue virus, but no vaccine or medicine has been developed to treat the illness. The incubation period before symptoms develop generally ranges from 4 to 10 days after infection. Therefore, early diagnosis would enable the patient to receive prompt medical attention and avoid further complications.

Currently, dengue infection is diagnosed in the laboratory by testing the patient’s blood sample for the presence of dengue antigens or antibodies. IBN’s device, on the other hand, is capable of detecting IgG, a dengue-specific antibody found at the onset of secondary infections, directly from saliva in one step.

Unlike blood samples, saliva can be collected easily and painlessly for rapid point-of- care diagnostics. However, unlike other body fluids, it cannot be applied directly to commercially available test kits as it would cause the sensor nanoparticles to stick haphazardly to the test strip. In addition, conventional paper-based tests are not designed to handle the larger sample volume of saliva required.

As described in the journal Lab on a Chip (see reference below), the IBN researchers used an innovative stacking flow design to overcome key challenges faced by existing lateral flow designs, such as those used in pregnancy test kits.

In IBN’s device, different flow paths are created for samples and reagents through a multiple stacked system. This allows the saliva sample to flow separately through a fiber glass matrix, which removes the substances that would interfere with the nanoparticle- based sensing system before it mixes with the sensor nanoparticles. IBN’s device configuration also helps to regulate the flow in the test strip, generating uniform test lines for more accurate results.

By simplifying the diagnostic procedure, the researchers hope to make the device as easy to use as over-the-counter pregnancy or fertility test kits. IBN’s oral test kit may be adapted to detect other infectious diseases. The IBN researchers are also investigating the use of other common fluid samples, such as blood, urine and serum for rapid, high- sensitivity test kits.

The Institute is currently collaborating with ARKRAY Inc., a pioneer in the field of automated analysis systems, to commercialize its paper-based diagnostic technology. In 2013, ARKRAY opened its first Asian research center outside Japan in IBN with an investment of S$9.1 million over five years. The research center is focused on developing novel detection kits for infectious diseases based on IBN’s innovative diagnostic platforms.

Mr. Atsushi Murakami, General Manager of the R&D Division of ARKRAY Inc., said: “We have developed an excellent working relationship with IBN over the past two years, and our research activities have progressed rapidly. Together, we will continue to focus on the successful commercialization of new technologies for the diagnosis of tropical infectious diseases.”

IBN has been focused on research in medical technologies since 2003, and has created unique devices and assays for the rapid and accurate diagnosis of diseases. The institute has an active portfolio of 500 patents/patent applications, of which 86 have been licensed. It has spun off seven companies in the medical technology sector and its innovations have attracted major interest from the industry.

Y. Zhang, J. Bai and J. Y. Ying, “A Stacking Flow Immunoassay for the Detection of Dengue-Specific Immunoglobins in Salivary Fluid,” Lab on a Chip, (2015) DOI: 10.1039/C4LC01127A

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Meningitis 10-Minute Diagnostic Test Receives £1.5m Boost

Medical expertise originating in Belfast's Royal Victoria Hospital that will produce tests diagnosing meningitis in 10 minutes has received a £1.5m boost.

Funding for HiberGene, which was co-founded by three doctors from Belfast's main hospital, has come from Kernel Capital through a Bank of Ireland fund, and private investors.

Dublin-based HiberGene, which is led by Brendan Farrell, will use the funding to get molecular tests for meningococcal meningitis and Group B Streptococcus, which afflicts perinatal babies and newborns, onto the market.

The tests use technology called loop mediated isothermal amplification (LAMP), which can diagnose in 'near-patient' settings like emergency rooms and delivery wards.

The Bank of Ireland medtech accelerator fund provided £375,000 in funding, with the rest from private investors.

Mr Farrell said: "We are very pleased to have secured our first round of financing and we are now ready to fully commercialise our first two products and to commence development of LAMP-based tests for other infectious diseases. Both the meningitis and Group B Streptococcus products meet a currently unmet clinical need for rapid and accurate testing."

The firm wants to develop further tests for other human infectious diseases in-house

Mr Farrell, a biochemist by training, said the company was formed after a meningitis test was developed by Prof Peter Coyle, Dr Derek Fairley and Dr Joe Kidney, all medics at the Royal.

The firm set up to develop the tests was established in the Republic around 2010.

"Tax benefits were better in the south, particularly research and development tax credits," Mr Farrell said.

But he said he hoped to open a research and development facility in Northern Ireland, and ultimately sell the tests to the NHS.

And while there was competition in the field of meningitis testing, the speed of HiberGene's test set it apart, Mr Farrell said.

"Nobody has a meningitis test that's so rapid. Meningitis can have fatal consequences if you don't diagnose it quickly.

"Rapid diagnosis is particularly important with children, who are unable to describe their symptoms accurately."

Jayne Brady, partner at Kernel Capital, added: "There is a significant market need for accurate, rapid, cost-effective and simple to use near-patient clinical testing for critical care infectious diseases.

"Kernel Capital, through the Bank of Ireland medtech accelerator fund, is delighted to support innovative early stage Irish companies like HiberGene Diagnostics to enable their product launch and market entry."

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