FDA’s New Strategic Plan for Regulatory Science Includes Rapid Micro Methods

On August 17, 2011, the U.S. Food and Drug Administration released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.

“The breadth and scope of FDA’s regulatory oversight is extraordinary, touching the lives of every American, through the food they eat, the medicines they take, and the medical devices they use,” said FDA Commissioner Margaret A. Hamburg, M.D. “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard.”

The strategic plan describes the agency’s intent to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It also underscores the agency’s emphasis on food safety.

The plan also emphasizes the agency’s intention to study and improve how it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive that information.

“New technologies provide unprecedented opportunities to prevent and cure disease and to grow our high tech economy,” said FDA Chief Scientist Jesse Goodman, M.D, M.P.H. “This plan will help turn advances in science into products that benefit people, and help FDA assure that happens more quickly and safely. It is win-win-win, because it will help the public, the agency, and developers of new products.”

The full plan (PDF format) may be downloaded at http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf.

A summary of the Strategic Plan is also available in an audio Podcast. Presented by Vicki L. Seyfert-Margolis, Ph.D., Senior Advisor for Science Innovation and Policy for the FDA Commissioner’s Office, the Podcast may be accessed at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm268093.htm.

For an overview of the Strategic Plan’s references to rapid methods, please read Dr. Miller’s blog at http://blog.rapidmicromethods.com.

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Journal of AOAC International Publishes Data on SDIX RapidChek® SELECT™ Salmonella Enteritidis Test System

SDIX, a leading supplier of rapid detection solutions to the $1 billion food pathogen testing market, today announced the publication of a scientific paper entitled "RapidChek® SELECT™ Salmonella Enteritidis Test System for the Detection of Salmonella Enteritidis in Poultry House Drag Swabs, Shell Egg Pools, and Chicken Carcass Rinsates". The publication was released by the Journal of AOAC International and was authored by Mark Muldoon, PhD, SDIX Senior Scientist, and colleagues. The article can be viewed at: http://aoac.publisher.ingentaconnect.com/content/aoac/jaoac/2011/00000094/00000004/art00016.

The article provides detailed performance specifications for the Salmonella Enteritidis (SE) solution, introduced by SDIX in July 2010. SDIX has already received Performance Tested Method certification from the AOAC as well as method equivalency from the FDA for this product. These determinations provide evidence that customers using the SDIX method are compliant with the FDA's Final Rule, which aims to reduce SE in egg production and the resulting risk of human illness related to this pathogen. The rule became legally effective on July 9, 2010.

The data presented in the AOAC paper demonstrate equivalent performance of the SDIX test with both the standard FDA BAM method for testing egg-pools and the USDA FSIS method for poultry carcass rinsates. Significantly, the results show superior performance of the SDIX method for environmental surveillance in poultry houses, when compared to the FDA BAM method, which is the industry's standard benchmark. Poultry house environmental surveillance is critical to the integrity of the food safety testing chain for table eggs. In addition to the sensitivity performance of the solution, as with all SDIX RapidChek methods, the SE test is fast, easy to use and less expensive than most alternatives, giving egg producers an avenue to address their testing needs with an economically manageable process.

Tim Lawruk, Food Safety Market Manager at SDIX, commented, "The publication of data for our RapidChek SELECT Salmonella Enteritidis Test System demonstrates the superior performance of the SDIX test over the current gold standard method. This should give food processors, as well as the public, added confidence in the ability to produce safe eggs that meet regulatory requirements. In addition, the SDIX testing solution provides a clear advantage in time-to-results, taking only two days for both drag swabs and eggs, compared to the FDA's three and seven day methods. As we expand our Food Safety business, SDIX remains committed to providing customers with economic solutions that best fit their business needs."

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IQuum Receives FDA 510(k) Clearance for Liat™ Influenza A/B Assay for Influenza Molecular Diagnostics in Approximately 20 Minutes

IQuum, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the Liat™ Influenza A/B Assay and the Liat™ Analyzer. This molecular diagnostic test is an automated sample-to-result multiplex real-time RT-PCR assay for the detection and discrimination of influenza A and influenza B in approximately 20 minutes. The test is intended for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform "moderate complexity" tests, enabling its use in hospital labs or other near-patient settings.

“The Liat Influenza A/B Assay presents a revolutionary improvement in the speed and ease-of-use of nucleic acid testing,” said Dr. Shuqi Chen, Chief Executive Officer of IQuum, Inc. “IQuum’s goal is to provide sophisticated nucleic acid tests that can be performed in near-patient settings and deliver accurate results to physicians and patients instantly. This regulatory clearance demonstrates the capability of the Liat system to realize this goal.”

Influenza is a highly contagious acute respiratory illness that affects between 5% and 20% of the U.S. population each year, leading to more than 200,000 hospitalizations and as many as 49,000 deaths, according to the U.S. Centers for Disease Control and Prevention (CDC). Influenza A, including subtypes A/2009 H1N1 and H3N2, and influenza B, are considered to be the predominant seasonal influenza viruses. Current near-patient influenza testing is performed using rapid immunoassays. However, studies have shown that such immunoassays have a sensitivity of only 10-70%.

The Liat Influenza A/B Assay is currently the only test that has equivalent or better sensitivity and specificity as current lab-based nucleic acid tests, while substantially matching the time-to-result and ease-of-use of rapid immunoassays. Having an operator hands-on time of less than 1 minute and a total time-to-result of approximately 20 minutes, the Liat test can be performed on-demand in hospital near-patient settings, providing physicians with accurate and timely results. The Liat system integrates multiple intelligent features, such as sample volume metering, on-board internal control, advanced error diagnostics, and automated data interpretation to ensure the quality of results when operated by minimally trained users.

IQuum’s Liat Analyzer is a sample-to-result molecular diagnostic system that refines the testing process to three simple steps: (1) collecting a raw biological sample into a Liat Tube, (2) scanning the tube’s barcode to identify the test and track the patient sample, and (3) inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required. Results are returned in as little as 20 minutes. The Liat Analyzer’s small size (~4.3” x 8” footprint), self-contained design, and robust error prevention features, will make it ideally suited for near-patient or on-site molecular diagnostics.

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Rheonix Announces New SeptiCARD Data Demonstrating Rapid Septicemia Diagnosis

Rheonix, Inc. announced positive results in a new application of its powerful, automated, molecular diagnostic platform, termed SeptiCARD, for the detection of septicemia, the presence of bacteria in the blood often associated with severe infection. Results were presented in a poster session at the American Association for Clinical Chemistry (AACC) Annual Meeting held in Atlanta, Ga., July 24-28, 2011. These data continue to support the Rheonix CARD® system’s utility across a range of molecular diagnostic applications.

“The results presented at AACC continue to raise the standard for speed and accuracy of diagnostic results straight from raw samples, such as whole blood,” said Tony Eisenhut, President of Rheonix, Inc. “The SeptiCARD is another important application of our versatile platform, and these data confirm results we have seen in our other development programs for immunoassay, pathogen identification, gene sequence detection, cell based assays and diverse molecular diagnostic applications. We look forward to submitting our first product, a warfarin sensitivity test, for FDA review by the end of the year.”

The current standard of care to detect bloodstream infections relies on time consuming blood culture methods. The Rheonix SeptiCARD, however, is able to take a whole blood sample and complete an accurate detection of bacteria in the blood, or septicemia, in less than three hours on a fully automated and closed system. This time saving is important, as mortality rates for patients with sepsis increase by approximately 8% for every hour of delay in diagnosis. The SeptiCARD utilizes a novel, dual-stage nucleic acid purification procedure designed to conduct multiplexed microbial detection for sepsis diagnosis. The SeptiCARD is placed into the Rheonix EncompassMDx™ workstation, which can simultaneously run six Rheonix CARD devices, allowing up to 12 individual samples to be automatically analyzed within a three-hour period. All steps of cell lysis, dual-stage DNA purification, multiplex PCR and endpoint detection are enclosed and fully contained within the SeptiCARD, allowing for fully-automated detection and reduced risk of cross-contamination. The SeptiCARD product is still in research phase and not yet FDA cleared for in vitro diagnostic use.

Study Results Presented at AACC:

In the poster titled “Two-step DNA isolation followed by PCR in a fully automated system to detect septicemia agents in whole blood,” Rheonix reported positive results for the rapid and accurate identification of septicemia agents using the Rheonix SeptiCARD device. The study analyzed 500 mcl of whole blood, spiked with 50 to 500 C. albicans cells, a septicemia pathogen, on the Rheonix SeptiCARD. The device performed a two-step DNA isolation, which yielded DNA of a superior quality to traditional isolation methods, and allowed for improved amplification of target sequences. There were no differences in detection between low or high amounts of C. albicans, indicating that the Rheonix platform is capable of detecting small amounts of pathogen that are present before severe disease results. Rheonix reported that the detection of other septicemia agents generated similar results.

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Quidel Receives CE Mark for Its Sofia Fluorescent Immunoassay Analyzer and Influenza A+B FIA Test

Quidel Corporation, a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received the CE Mark for its Sofia(R) Fluorescent Immunoassay Analyzer and for its Sofia(R) Influenza A+B Fluorescent Immunoassay (FIA).

Sofia is the brand name for Quidel's next generation, immunoassay system. The Sofia Analyzer and Sofia Influenza A+B FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail safe systems to ensure a reliable, objective, rapid, and highly accurate diagnostic result. The Sofia Analyzer is light weight, has a small footprint, and has operational flexibility making it easy to use in small and large laboratories. It also provides a permanent test result record and can be readily networked for electronic transmission of test results.

The Sofia Influenza A+B FIA is the first of several forthcoming diagnostic assays for infectious disease and other disorders that will incorporate Sofia-related immunochemistry and will use the Sofia Analyzer. The CE mark allows Quidel to launch the Sofia Immunoassay Analyzer and Sofia Influenza A+B FIA in advance of the upcoming influenza season in Europe and in other locations outside the United States. The product is currently not for sale in the U.S.

"Obtaining a CE mark for our Sofia Analyzer and Influenza Assay ahead of the next flu season is a significant accomplishment," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are very delighted with the milestones we have achieved with respect to our new product pipeline, and specifically with our next-generation immunoassay platform."

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Lab-on-a-chip Could Streamline Blood Testing Worldwide

An inexpensive and portable blood test could provide a breakthrough in diagnosing infections and has been proven as accurate as expensive hospital-based testing in the detection of HIV, syphilis and other diseases, according to a new study released Sunday. Samuel K. Sia, assistant professor of biomedical engineering at Columbia Engineering, has developed the innovative strategy for an integrated microfluidic-based diagnostic device. The mChip, as it is called, has been tested with hundreds of patients in Rwanda, with nearly 100 percent accuracy.

The mChip (lab-on-a-chip) can perform complex laboratory assays, and do so with such simplicity that the tests can be carried out in the most remote regions on Earth. The credit card-sized chip can diagnose infections within minutes, according to the study published in the journal Nature Medicine. “The idea is to make a large class of diagnostic tests accessible to patients in any setting in the world, rather than forcing them to go to a clinic to draw blood and then wait days for their results,” Sia told the AFP news agency. With a projected production cost of $1 dollar per unit, the mChip would be far cheaper to administer than current lab-based tests.

Because the mChip can scan for multiple proteins, each corresponding to a particular disease, at the same time with a single blood sample, it is probably even cheaper than strips which work like store-bought pregnancy tests, and are more accurate to boot. “Current rapid HIV tests require subjective interpretation of band intensity by the user that can result in false positives,” that is, healthy individuals being misdiagnosed, the study noted. The mChip, however, allows for measurement using a handheld instrument - which costs about $100 -- that is no more complicated to use than a cell phone, according to researchers. The device will produce accurate results within minutes rather than the standard days or weeks.

The device contains a microchip housed inside an injection-molded plastic casing, explained Vincent Linder, Chief Technological Officer at Claros Diagnostics, which owns or has licensed relevant patents.

A nano-sized gold “reagent” -- which detects a substance via a chemical reaction -- is injected, followed by a silver one that interacts with the gold to produce an ultra-thin film. “The darkness of the film is proportional to the concentration of biomarker in the sample,” said Linder, comparing the steps to the development process in non-digital photography. The results can be measured with a LED-based detector or can be viewed by the naked eye.

Sia and his colleagues tested the mChip prototype in Muhima Hospital in Kigali. From a total of 70 specimens with known HIV status, only one tested false, a result that rivals the accuracy of lab-based HIV testing. Similar tests on more than 100 archived specimens yielded similarly reliable results, as did further trials based on samples from female sex workers known to be infected with both HIV and syphilis. Sia hopes the mChip can be used to help pregnant woman in Rwanda who, while they may be suffering from AIDS and STDs, cannot be diagnosed with any certainty because they live too far from clinics or hospitals that have labs.

“Diagnosis of infectious diseases is very important in the developing world,” Sia said. “When you're in these villages, you may have the drugs for many STDs, but you don't know who to give treatments to, so the challenge really comes down to diagnostics.” Currently, less than 25 percent of pregnant women in low- and middle-income countries are tested for HIV, a figure which provides limited hoping of reaching the UN goal of eliminating mother-to-child transmission of the disease by 2015, according to the 2010 UNAIDS Report on the Global AIDS Epidemic. In Zambia and the Democratic Republic of Congo, for example, only nine and six percent, respectively, of pregnant women currently receive HIV testing, according to the report.

A version of the mChip that tests for prostate cancer has also been developed by Claros Diagnostics and was approved in 2010 for use in Europe.

Sia's work also focuses on developing new high-resolution tools to control the extra-cellular environments around cells, in order to study how they interact to form human tissues and organs. His lab uses techniques from a number of different fields, including biochemistry, molecular biology, microfabrication, microfluidics, materials chemistry, and cell and tissue biology.

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SmartGene and the Institute of Medical Microbiology, University of Zurich Expand Their Collaboration to Address the Sequence-Based Validation of Mass Spectrometry Platforms for Clinical Microbiology

SmartGene, a provider of innovative software services for the management and analysis of genetic data, and the Institute of Medical Microbiology ("IMM"), University of Zurich, Switzerland, today announced an expanded collaboration, under which the University of Zurich will make use of the SmartGene platform and its associated reference databases to validate and provide ongoing back-up for mass spectrometry analysis, for the identification of infectious pathogens in diagnostic routine procedures.

The parties already enjoy a long-standing relationship, under which SmartGene's advanced technology and integrated Web-based services are used by the IMM for the analysis and identification of bacterial, fungal and mycobacterial pathogens by sequence analysis. The IMM is one of Europe's leading centers of expertise for molecular and conventional diagnostic microbiology and serves as a national and international reference laboratory. Experts at IMM conduct various research projects and also curate an ITS sequence reference database for identifying yeasts and molds, which is available to other institutions via SmartGene's service platform.

Clinical microbiology is undergoing a paradigm shift, whereby novel technologies such as mass spectrometry will partially replace conventional culture-based methods for identification of bacterial pathogens. The introduction of mass spectrometry technology promises a shorter turn-around time for results, along with reduced labor and consumable expense per test. However, earlier studies suggest that mass spectrometry may partly not be sufficiently discriminatory, for which case sequence-based identification will serve as back-up and gold standard. The IMM plans to work out an optimized workflow for the routine clinical laboratory, hence taking advantage of its long-standing expertise in sequence-based identification.

Erik C. Boettger, MD, Professor of Medicine and Microbiology, and the Director and Chairman of the Institute of Medical Microbiology at the University of Zurich, stated that: "Our institution has a long term expertise in implementing new technologies in the diagnostic laboratory, and we have always paid attention to carefully optimizing the work flow. We will now evaluate how mass spec technologies and sequence-based identifications can work together in our laboratory, for best accuracy and efficiency in supporting patient care. With mass spec platforms holding the promise of rapid identification of microorganisms, it is critical for the quality of our work, to be able to back-up and complement these results with our DNA sequencing routine and with our database cumulated from many clinical isolates over the years. Given the diversity of microorganisms, sequencing of microbial genes will play an important role in a modern microbiology laboratory. At our institution we appreciate SmartGene's technology which helps us not only to streamline sequence analysis, but also to leverage the expertise gained with the analyzed isolates."

"We are very happy to expand the scope of our collaboration with Professor Boettger and his team," said Stefan Emler, MD, Chief Executive Officer of SmartGene GmbH. "It is very important for the community to position mass spectrometry methods for pathogen identification in the context of species diversity, evolution and changing taxonomy. The introduction of these new techniques, together with the increasing scarcity of expertise in conventional culture-based identification, reinforces the continuing importance of sequencing as the gold standard. SmartGene already facilitates the efficient and accurate identification of pathogens by sequencing; this expanded collaboration with IMM is another step towards our goal of ultimately providing solutions which address pathogenicity, drug resistance and host susceptibility for best management of challenging infections."

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Abbott Introduces Vector-borne Pathogen Test to Detect Microorganisms Carried by Ticks and Other Insects

Abbott's Ibis Biosciences today introduced a new molecular assay to detect a wide variety of vector-borne microorganisms, including those known to cause Lyme Disease, Rocky Mountain Spotted Fever, Babesiosis, Ehrlichiosis and Anaplasmosis. Vector-borne pathogens are microorganisms that are typically transmitted by arthropods such as ticks, mosquitoes or fleas.

The PLEX-ID™ Vector-borne test, which is intended for non-diagnostic use, has been designed to support bioresearch, environmental surveillance, and other activities central to the detection and identification of vector-borne pathogens.

"The PLEX-ID Vector-borne test is a single broad-range molecular assay that can detect a wide array of microorganisms and mixtures of microorganisms in a single specimen," said Mark Eshoo, Ph.D., director, New Technology Development, Ibis Biosciences. "The test can identify protozoa, bacteria, and nematodes, in a wide range of specimen types, including ticks, fleas, blood or tissue."

Dr. Eshoo led a study in which vector-borne disease surveillance researchers in New York and Connecticut collected 299 blacklegged ticks. The ticks were analyzed using the Ibis technology for a wide range of vector-borne microorganisms. Results showed that two-thirds of the ticks were infected with B. burgdorferi, the agent of Lyme disease, and a third of these positive ticks contained other tick-borne co-infections such as Babesia microti or Anaplasma phagocytophilum. The research demonstrated that the Ibis technology can detect and identify B. burgdorferi as well as co-infection in ticks with other vector-borne pathogens quicker than traditional lab methods.

About PLEX-ID

Currently intended for non-diagnostic use, PLEX-ID is the only high-throughput technology that offers rapid and broad identification, detailed genotyping and characterization, and recognition of emerging organisms. The system employs a combination of molecular technologies, including polymerase chain reaction (PCR) for gene amplification and mass spectrometry analysis to rapidly characterize known and unknown organisms. It is designed to address a significant unmet need by providing test results in less than eight hours instead of three or more days required with blood and tissue culture-based methods.

PLEX-ID is designed to identify a broad range of bacteria, viruses, fungi, certain parasites, and also provide information about drug resistance, virulence, and strain type. Anticipated public health and biodefense applications include epidemiologic research and identification of emerging or previously unknown agents. In addition, the system is being used for forensic characterization of human samples.

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Meridian Bioscience Launches ImmunoCard® C. difficile GDH Assay in Europe

Meridian Bioscience, Inc. VIVO +3.82% is pleased to announce the launch of a new Clostridium difficile rapid test, ImmunoCard C. difficile GDH. This assay detects the common antigen, Glutamate dehydrogenase, produced by toxigenic and non-toxigenic strains of Clostridium difficile. Toxigenic strains of Clostridium difficile are frequently associated with hospital and community acquired diarrhea and can lead to life-threatening complications or death. ImmunoCard C. difficile GDH can be used by laboratories worldwide to screen patients with diarrhea for C. difficile. To differentiate those patients at risk of disease associated with toxigenic C. difficile, GDH-positive patients are often confirmed with toxin-detecting tests such as highly sensitive molecular assay, illumigene(R) C. difficile.

With the addition of ImmunoCard C. difficile GDH, Meridian Bioscience is uniquely positioned in the market as the only manufacturer able to provide a complete portfolio of C. difficile testing solutions that can meet the needs of our global customers. The combination of ImmunoCard C. difficile GDH and illumigeneC. difficile provides laboratories with an algorithmic option to C. difficile diagnostic testing.

Richard Eberly, Chief Commercial Officer stated, "C. difficile is a very dangerous infection that can lead to severe consequences for the patient and for the healthcare institutions that care for them. The addition of ImmunoCardC. difficile GDH continues Meridian's legacy of leadership in the detection and identification of C. difficile. In addition, this new product in conjunction with the Meridian illumigeneC. difficile technology empowers laboratories to identify C. difficile patients with both a rapid screening test and molecular confirmation in less than two hours."

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PolyU Takes Steps to Enhance Food Safety and Technology

The Hong Kong Polytechnic University (PolyU)'s Department of Applied Biology and Chemical Technology (ABCT) has recently established the Food Safety and Technology Research Centre with an aim of raising the standard of food safety by providing research, consultancy and training services to food and related industries in Hong Kong and the Pearl River Delta Region.

The first of its kind run by a higher education institution, the Food Safety and Technology Research Centre was officially opened today (9 August) by Mr Clement Leung, Director of Food and Environmental Hygiene, Food and Environmental Hygiene Department, HKSAR Government; Professor Timothy W. Tong, PolyU President; and Professor Wong Wing-tak, Head of ABCT and Director of the Food Safety and Technology Research Centre. This event has drawn nearly 200 participants from the Chinese mainland, Hong Kong and Taiwan, including government officials, renowned academics and industry professionals.

Speaking at the opening ceremony, Professor Tong said, "PolyU is committed to raising food safety standard through education and research. Building on our strengths in food science research and education, we believe that the Centre will serve as an international platform for knowledge and technology transfer, as well as for collaborations and information sharing on the constant challenge of ensuring food safety."

Following the ceremony was an open forum on "Food Safety Highlights in Hong Kong and Mainland China" held on the PolyU campus. Professor Wu Yongning from National Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention and Professor Laurie Chan from the School of Health Sciences, University of Northern British Columbia were invited to share their insights and experience in enhancing the safety of food. Professor Wu spoke on "Capability Building of Food Safety Issues: Where do we stand in China?" while Professor Chan talked about "Tackling Food Safety Issues: How can scientists help?"

Headed by Professor Wong Wing-tak, the Research Centre is founded with a mission to become a first-class centre with leading authority and excellent services in the areas of food safety and food technology. "By bringing together expertise of various areas, the new Centre will not only help raise the standard of food safety and the related testing and certification, but also facilitate inter-disciplinary collaborations in the region. The Centre will be actively engaged in food science research and new technology development and provide training and consultancy service for the industry. In the long run, we hope we could bolster public confidence on the safety of food supplies," said Professor Wong.

The Department of Applied Biology and Chemical Technology is a multi-disciplinary department that embraces chemistry, biology, biochemistry, biochemical engineering and food science. Over the past decade, the research team has dedicated efforts to develop rapid detection methodologies that can identify harmful substances in food products. To cater for the need of the community, the Department launched the Bachelor of Science (Honours) in Food Safety and Technology programme in 2009, nurturing professionals for the industry.

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T2 Biosystems Completes $23 Million Financing to Support Development and FDA Submission of First Direct Detection Diagnostic Platform

T2 Biosystems® announced today that it has closed a $23 million series D financing. The round was led by new investor Aisling Capital, LLC, which was joined by existing investors Flagship Ventures, Polaris Venture Partners, Flybridge Capital Partners, Physic Ventures, Partners Healthcare, Arcus Ventures, RA Capital, Camros Capital and WS Investments. In conjunction with the financing, Josh Bilenker, M.D., Principal at Aisling Capital, will join T2 Biosystems’s Board of Directors. The proceeds from this round will support ongoing development and clinical trials as the Company moves towards regulatory approval and commercialization of their T2MR diagnostic technology, as well as enable expansion of the Company’s partnering program. T2 Biosystems’s lead product is a rapid detection assay for Candida, a fungal pathogen known to cause blood stream infections and sepsis.

“T2 Biosystems is developing a platform that will fundamentally improve current diagnostic standards by enabling a broad menu of molecular and immunodiagnostic tests from a single sample,” commented John McDonough, CEO and President of T2 Biosystems. “Our direct detection method has shown superior performance on a broad range of analytes with high sensitivity, specificity and precision in comparison studies with real patient samples. We look forward to the beta launch of our T2Dx diagnostic instrument this fall.”

McDonough continued, “The new funding will support the activities to advance our T2Candida test panel toward an expected FDA submission in the second half of 2012, and accelerate the development of our pipeline of additional diagnostic tests focused on sepsis, infectious disease, therapeutic drug monitoring and coagulation.”

“T2 Biosystems has generated provocative data showing reliable and sensitive detection of DNA, protein and small molecule targets in whole blood and other raw clinical samples,” said Dr. Bilenker. “An affordable benchtop system with walk-away usability for lab technicians and a wide potential menu of tests could transform the way lab medicine is practiced. Importantly, the management team at T2 Biosystems has an impressive track record of developing partnerships within the industry and bringing novel biotechnology products through development and into the market.”

The T2MR technology is a direct detection diagnostic method that eliminates the need for sample purification and growth of blood cultures and provides sensitive and rapid results in less than 2 hours, compared to current standards that require one or more days. The T2Dx benchtop instrument is the first device to utilize the T2MR technology to analyze unprocessed samples for important classes of diagnostic targets. T2 Biosystems’s lead product, the T2Candida assay, is designed to provide life and cost-saving benefits to patients and hospitals through direct detection and multiplexed analysis of five species of the fungal pathogen Candida. Data from evaluations of the T2Candida assay will be presented at upcoming medical meetings.

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Roka Bioscience Introduces Fully Automated Molecular Solution for Food Pathogen Testing at IAFP Annual Meeting

Roka Bioscience participated in the International Association for Food Protection (IAFP) Annual Meeting held July 31 through August 3, 2011 in Milwaukee, Wisconsin. The company was among the approximately 125 exhibitors at the meeting, which marked the 100th anniversary of the association.

At the meeting, the company introduced its new Roka Automated Instrument, an innovative fully automated molecular system for the detection of food pathogens in food and environmental samples. The instrument utilizes a simple three-step procedure—Enrich, Transfer, Automate—and is capable of processing over 300 samples in 8 hours. The instrument's dynamic scalability and high throughput provides greater efficiency, flexibility, and freedom to meet the ever-increasing demands placed on food safety laboratories.

The first assays to be commercialized on the Roka Automated Instrument are Listeria and Salmonella detection assays. Additional assays are currently in development.

"We are thrilled to introduce the Roka Automated Instrument at the IAFP Annual Meeting, which marks such an important anniversary for this organization and the entire food safety industry," stated Paul G. Thomas, Roka Bioscience CEO and President. "This instrument gives laboratories the speed and accuracy they need, with greater flexibility and freedom than they thought possible. We are excited to partner with companies and show them what this fully automated molecular solution can do for their testing laboratories. The Roka Automated Instrument truly has the power to revolutionize food safety testing as we know it."

In addition to exhibiting at the meeting, Roka offered personal demonstrations of the instrument to over 125 attendees. The company also presented posters highlighting the instrument's proprietary technology as well as notable results achieved with the Listeria and Salmonella detection assays.

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BD and Lab21 Collaborate to Develop Aspergillus Assay for New BD MAX™ Molecular Testing System

BD Diagnostics, a segment of global medical technology company BD (Becton, Dickinson and Company), and Lab21, a global leader in personalised healthcare, announced today a collaboration to develop a state-of-the-art molecular diagnostic assay to detect the life-threatening Aspergillus fungus using the new fully automated BD MAX™ Molecular Testing System.

"The potential to detect Aspergillus in blood using real-time polymerase chain reaction is a topic of great interest to clinicians since it offers faster, more sensitive and more accurate diagnostic and screening strategies for the early and definitive detection ofaspergillosis," said Graham Mullis, CEO of Lab21.

Infection caused by Aspergillus is a leading cause of infectious death in immunocompromised patients, with an estimated 10 million people at risk globally each year. Studies have shown that diagnosis of Aspergillus infection followed by antifungal treatment within the first 10 days of infection reduces mortality from 90 percent to 40 percent - highlighting the need for rapid, accurate testing. Real-time polymerase chain reaction may offer significant advantages in sensitivity and specificity over the current culture techniques.

"This agreement with Lab21 is designed to add an innovative molecular test to the BD MAX System's growing test menu that will empower clinicians and laboratory professionals with rapid, accurate information on which to base important treatment decisions," said Tom Polen, President, BD Diagnostics - Diagnostic Systems. "By collaborating with best-in-class in vitro diagnostics developers such as Lab21, our goal is to make the BD MAX System an indispensible tool in clinical laboratories by providing them with an ever-expanding test menu on a fully automated platform."

According to Polen, BD plans to bring new assays to the BD MAX System in a broad range of disease categories. With this announcement, there are now more than 14 assays in the BD MAX System's content-rich menu pipeline. Combined with open capability, full automation and standardized workflow, BD MAX System will enable laboratories to consolidate and standardize their molecular tests to build programs that meet both their current and future clinical needs.

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Quidel Receives CE Mark for Its First Molecular Diagnostic Test

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received the CE Mark for the Quidel® Molecular Influenza A+B Real-Time RT-PCR Assay -- its first molecular diagnostic test. This is the first of several forthcoming Quidel Molecular Real-Time PCR Assays that provide important benefits to the customer, including, among others, room temperature storage, reduced process time, and ready-to-use reagent configurations.

The CE mark clears the way for the launch of the open box molecular platform well in advance of the forthcoming influenza season in Europe, while also facilitating the launch of the product in other ex-U.S. locations. The product is not for sale in the U.S. at this time.

"Completing the development of our Quidel Molecular Influenza A+B Real-Time RT-PCR Assay is just the beginning of a new and very exciting time for our company," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our molecular diagnostic program is proceeding on schedule and shows great promise for the coming year."

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SDIX to Introduce Two New Food Pathogen Testing Solutions at IAFP Annual Meeting

SDIX™, a leading supplier of rapid detection solutions to the $1 billion food pathogen testing market, today announced that the company is introducing two new food pathogen monitoring tools at the International Association of Food Protection (IAFP) Annual Meeting in Milwaukee, Wisconsin, taking place from July 31 through August 3.

As the next generation in environmental Listeria testing, SDIX will be introducing the RapidChek® Listeria F.A.S.T.™ test system -- Fast Accurate Sensitive Technology. The RapidChek F.A.S.T. system provides a one-step detection of Listeria species from various environmental surfaces in as little as 24 hours. The simplified protocol and next-day results provide food processors with earlier product release, while maintaining highly accurate results.

To enable data management capability for the RapidChek platform, SDIX will also be introducing the SDIX RapidScan™ Data Management System. The RapidScan system is comprised of a reader and proprietary software that allows for the objective interpretation of RapidChek pathogen detection strips and the electronic integration of the results into laboratory information management systems (LIMS), eliminating operator interpretation and transcription errors.

Tim Lawruk, Food Safety Market Manager at SDIX, said, "The introduction of these new systems marks an important expansion of our Food Safety product portfolio. The addition of the SDIX RapidScan data management and LIMS integration capability to the RapidChek workflow will provide food testing laboratories with a cost-effective solution that enhances the simplicity and accuracy of our process monitoring approach. In addition, the introduction of the RapidChek Listeria F.A.S.T. system will provide food processors with the first true 24-hour test method for the detection of Listeria on environmental surfaces. The advantages of releasing product even 2-4 hours faster include lower storage requirements and extended product shelf-life, both of which provide important economic benefits. The RapidChek Listeria F.A.S.T. system will be a valuable tool as all federally and state inspected meat and poultry plants in the United States look to comply with the USDA-FSIS mandated 'test and hold' program for product being tested for pathogens."

Added Klaus Lindpaintner, M.D., Chief Scientific Officer at SDIX, "As a leader in antibody development and antibody-based pathogen detection systems, SDIX continues to work towards expanding our product line to provide pathogen testing solutions to the industry that are simple to use, highly dependable, and economically attractive. We believe that our products are ideally suited to meet processors' needs for high feasibility pathogen testing, thus allowing them to comply with regulatory requirements, while responsibly contributing to enhancing public health and safety."

RapidChek® and RapidChek® SELECT™ are easy to use, accurate and affordable pathogen detection systems. Each test provides an integrated solution that includes optimized reagents for both enrichment and detection. The proprietary enrichment media ensures superior recovery and growth of the target pathogen, if present in the food sample, and the test strips provide clear and rapid results. Currently, RapidChek methods are available for the detection of E. coli O157 (including H7), Salmonella species, Listeria species and Salmonella Enteritidis.

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Akonni Awarded $300K Grant from National Institutes of Health to Develop RT-PCR Microarray for Detecting Viruses in Human CSF

Akonni Biosystems, a molecular diagnostics company that develops novel nucleic acid extraction and microarray-based testing systems designed to rapidly and economically analyze biological samples, today announced receipt of a $300K grant from the National Institutes of Health (NIH). The award will enable Akonni to accelerate the research and development of a closed amplicon RT-PCR microarray for the detection of enterovirus, herpes viruses (HSV-1, HSV-2, VZV, CMV, HHV-6) and West Nile virus in cerebral spinal fluid (CSF). Collaborating with Akonni Biosystems on this project will be the Laboratory of Viral Diseases at the Wadsworth Center of Albany, New York.

Encephalitis and meningitis are potentially fatal diseases defined by acute inflammation of the brain or protective membranes covering the brain and spinal cord, and are often caused by viruses, bacteria, fungi, or parasites. The potential for, and nature of, medical complications arising from CSF infection vary with the causative organism, as does the choice of appropriate treatment. Rapid and accurate identification of viral nucleic acid in the CSF of a patient with encephalitis or meningitis can help direct therapy and minimize morbidity and mortality.

Nucleic acid amplification and detection assays have been considered the tests of choice for viral CSF infections for more than a decade. This project will further study, develop, and test a “closed amplicon” gel element RT-PCR microarray and contribute to the development of more rapid, affordable and comprehensive methods for diagnosing viral encephalitis and meningitis.

“The development of rapid, low cost, molecular diagnostic tests for use in near point-of-care settings has the potential to change the way CSF infections are identified,” states Kevin Banks, Ph.D., Vice President of Sales and Marketing at Akonni Biosystems. “Combining RT-PCR with our proprietary gel-drop microarray platform in a self-contained micro-fluidic chamber will further enhance our ability to develop and deploy multi-test panels to affordably and rapidly detect viruses, bacteria, fungi and parasites in a single patient sample.”

Akonni Biosystems was founded in 2003 and has over 15 patents owned or exclusively licensed with more than three dozen others pending. The company’s core technology is based on work developed at Argonne National Laboratory and the Engelhardt Institute of Molecular Biology and utilizes gel-drop array technologies optimized for medical applications. Supported by a series of government grants and contracts from NIH, CDC, DOE, DOD, NIJ, and NSF, the company has significantly advanced the original technology by improving the system’s capabilities from sample preparation to final result. Commercial products and products in its near-term pipeline include rapid sample preparation methodologies for nucleic acid extraction and multiplex panel assays for detecting multidrug-resistant tuberculosis (MDR-TB), upper respiratory infections, viral encephalitis, and hospital-acquired infections (MRSA).

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Intelligent Medical Devices, Inc. (IMDx) Introduces a CE-Marked Automated Assay for the Detection of C. difficile Including Hypervirulent Strains

Intelligent Medical Devices, Inc. (IMDx) today announced it has received CE-Mark for a high-throughput automated assay for the detection of C. difficile, including the A-B+ 1470 variant, as well as the NAP1 strain. The IMDx™ C. difficile assay for the Abbott m2000™ is the first assay released under a multi-year distribution agreement between Abbott and IMDx whereby IMDx will design, develop, regulatory clear, and manufacture assays for the Abbott FDA cleared m2000 instrument.

Designed utilizing IMDx's proprietary bioinformatics process, the IMDx C. difficile assay for the Abbott m2000 demonstrates a sensitivity of 95.7 percent and a specificity of 100 percent (internal comparison data). C. difficile may develop after prolonged antibiotic use and is the most frequent cause of health-care-associated diarrhea, also causing more severe intestinal conditions such as colitis. The bacterium is easily transmitted via direct contact with high-touch surfaces in patient rooms, contaminated patient-care items, and hands of health-care workers.

"Our assays are developed to incorporate evolving clinical needs. Not only do we offer automated detection of toxigenic C. difficile genes, shortening the time needed to diagnose infections, but we also cover the detection of hypervirulent strains, including NAP1, and tcdB-variant strains, including 1470. Early identification of pathogens is critical in improving patient healthcare, shortening hospital stays, and reducing expenses," says Alice Jacobs, MD, Chairman & CEO of IMDx.

Based in Cambridge, MA, IMDx is an innovative company that designs, develops and manufactures molecular diagnostic products. IMDx has developed molecular solutions that are clinically impactful and competitively differentiated for a range of disease areas for current and next generation systems, including targets in infectious diseases, oncology and genetics. IMDx's expertise spans evolutionary biology, bioinformatics, microbiology, chemistry and molecular biology. These capabilities are harnessed by IMDx's proprietary bioinformatics and product development processes allowing for the rapid design and development of tests to meet clinical needs.

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Seegene Introduces Anyplex™plus MTB/NTM/DR-TB Real-time Test, a One-Stop Solution for Diagnosing Tuberculosis

Seegene announced that Anyplex™plus MTB/NTM/DR-TB Real-time Test, a total solution for diagnosing Mycobacterium tuberculosis (MTB), was introduced at the 2011 Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry in Atlanta, GA, July 26-28, 2011.

Every year 9.4 million people are newly infected with MTB, and 1.7 million people die yearly from the disease. The emergence and spread of drug-resistant MTB threatens global MTB control efforts, and there is an urgent need for a one-stop diagnostic test that rapidly detects and differentiates MTB from non-tuberculosis mycobacteria (NTM), and detects resistance associated mutations to various anti-MTB drugs.

Seegene's new product, Anyplex™plus MTB/NTM/DR-TB Real-time Test, provides a one-stop solution in the diagnosis of -- and treatment selection for -- mycobacteria infections. Anyplex plus MTB/NTM/DR-TB detects Mycobacterium tuberculosis, non-tuberculosis mycobacteria, and the presence of key resistance mutations to anti-MTB drugs in a single test.

The Anyplex™plus MTB/NTM/DR-TB firstly detects MTB and discriminates it from NTM in less than 2 hrs. In the case of MTB-positive, further analysis for drug-resistance to Isoniazid (INH), Rifampicin (RIF), all fluoroquinolone (FQ), and the injectable drugs (i.e., amikacin, kanamycin, or capreomycin) is performed to identify whether the MTB is multi drug-resistant MTB (MDR-TB), or extensively drug-resistant MTB (XDR-TB) in less than 40 min. In the case of NTM-positive, the identification of the three most associated with human disease, M. avium complex (MAC), M. kansasii, and M. abscessus, is carried out. This testing process will provide an effective one-stop diagnostic workflow for prompt mycobacteria detection and treatment.

Seegene's innovative DPO™ and READ technologies enable the test to perform multi-target detection with high specificity and sensitivity. There are a multitude of genetic mutations in MTB that are associated with drug resistance. To date conventional PCR methods have not been able to accurately discriminate all of these mutations. However, with Anyplex™plus MTB/NTM/DR-TB each drug-resistant mutation targeted is amplified by the corresponding DPO primer pair and detected specifically by READ technology, which is neither a probe-based method nor a melting temperature analysis method.

"Making an accurate diagnosis quickly is crucial to curing a MTB infection and limiting its spread to others. By providing a 'one-stop' test for MTB and MTB drug resistance based on the DPO and READ technologies, the Anyplex™plus MTB/NTM/DR-TB Real-time Test gives healthcare workers a powerful tool for rapid detection of a comprehensive range of MTB strains and mycobacteria," said Dr. Jong-Yoon Chun, Chief Executive Officer of Seegene.

Anyplex™plus MTB/NTM/DR-TB Real-time Test will not be available in the USA until regulatory clearance is obtained.

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Micro Imaging Technology and EPIC Corporation Announce a Significant Equity Alliance

Micro Imaging Technology, Inc. announced that it has entered into a significant long-term equity alliance with EPIC Corporation. Under the terms of the signed Memorandum of Understanding, EPIC has committed to purchasing a substantial equity position in MIT and, as a health care products supplier, will receive the benefits of MIT's revolutionary technology.

MIT has developed and patented a Microbial Identification System that revolutionizes the pathogenic bacteria identification process and can annually save thousands of lives and tens of millions in health care costs. The MIT 1000 System is believed to be the fastest and most inexpensive bacterial identification system available; identifying bacterial strains in less than five minutes, at a cost of less than 10 cents per test and extremely easy to operate. The MIT 1000 System has been certified by the AOAC Research Institute (AOAC RI) as a test method for Listeria, one of the three pathogens that are responsible for most of the worldwide food contaminations. The Company is in the process of preparing the MIT 1000 System for further certifications for the identification of both Salmonella and E. coli later this year. This will give the MIT 1000 System the certified ability to identify all "three of the major infectious pathogens" within five minutes and with a single test.

"EPIC is fortunate to become a part of Micro Imaging Technology," said Ronald Tucker, CEO of EPIC. "We believe that Micro Imaging is undervalued. The Company's balance sheet fails to reflect the value of the commercialized device for identifying bacteria and the 20 or more libraries that can be used to identify other bacterium, including MRSA."

"EPIC's business plan is to enter into agreements with companies like Micro Imaging, who are developing technologies to provide people with better healthcare. The essence of these agreements is to provide the companies with funding for regulatory approval, product commercialization, product procurement, marketing and distribution," stated Mr. Tucker.

Replying, Michael Brennan, MIT's Chairman, said, "The agreement with EPIC will provide us with needed funding now that we have entered our production stage and provides a partner that is very familiar with the healthcare industry. This will enable MIT to approach other markets in healthcare in addition to the $5 billion food safety segment."

MIT is a California-based public company that has developed and patented a Rapid Microbial Identification System that revolutionizes the pathogenic bacteria diagnostic process and can annually save thousands of lives and tens of millions of health care costs. The System identifies bacteria in minutes, not days, and at a significant per test cost savings when compared to any conventional method. It does not rely on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis. The process is totally GREEN requiring only clean water and a sample of the unknown bacteria. Revenues for all rapid testing methods exceed $5 billion annually -- with food safety accounting for over $3.5 billion, which is expected to surpass $4.7 billion by 2015 according to BCC Research. In addition, the recently passed "New" U.S. Food Safety Bill is expected to further accelerate the current CAGR growth rate of 6.6%.

MIT previously completed an extensive evaluation by the AOAC RI Institute which included rigorous independent testing and thorough reviews by its expert examiners, including the U.S. Department of Agriculture. The AOAC RI Report is available from the Company.

MIT has also demonstrated the ability to detect and identify, within several minutes, the microbes Escherichia coli, Listeria, Salmonella, Staphylococcus aureus, and other pathogenic bacteria. MIT recently performed over 300 tests for the identification of these contaminants and scored 95% accuracy. The System can currently identify 23 species of bacteria and its capabilities are easily expanded. The identification process has been verified by North American Science Associates, Inc. (NAMSA), an independent and internationally recognized microbiological testing laboratory. The NAMSA Test Report is available from the Company and, in MIT's opinion, demonstrates the accuracy, speed and cost effectiveness of the System over conventional processes.

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Provincial Investment Supports Commercialization of Leading-Edge Molecular Diagnostic Screening Technology

Xagenic Inc., one of MaRS Innovation's (MI) portfolio investments, was awarded $1-million in funding by Ontario's Ministry of Research and Innovation (MRI) through its Investment Accelerator Fund-Life Sciences (IAF-LS) program. The announcement was made at MaRS by Research and Innovation Minister Glen Murray.

"Today's announcement will go a long way in helping us to commercialize a technology that will ultimately shape the future of diagnostic testing - instead of waiting days for results, doctors and patients will only need to wait minutes," said Dr. Shana Kelley, Founder of Xagenic Inc. and Professor from the Leslie Dan Faculty of Pharmacy and the Faculty of Medicine at the University of Toronto.

Xagenic has pioneered a revolutionary class of chip-based molecular diagnostics. Using a breakthrough in engineering matter at the nanoscale, Xagenic employs its patented nanostructured microelectrodes to achieve highly sensitive nucleic acid sensors that detect DNA and RNA at record-breaking speed. The diagnostic screening technology was developed at the University of Toronto.

Unlike existing molecular tests which are complex, time-consuming and require skilled laboratory technicians, the Xagenic technology enables faster detection of pathogens -- in less than 30 minutes. For patients, faster diagnosis of conditions (ranging from infectious disease to cancer) can mean less anxiety and faster treatment decisions. For Ontario's strained health care system, the accurate and rapid technology will enable more efficient, on-site detection of pathogens in the comfort of a physician's office or by the patient's bedside.

"We're thrilled that the Ministry of Research and Innovation shares our vision to bring to market Xagenic's innovative technology. Xagenic is a prime example of how MaRS Innovation and its member institutions can turn a powerful idea into reality and deliver tangible benefits to patient care as well as fuel the knowledge economy," said Rafi Hofstein, CEO of MI and Xagenic Inc.

"We're proud of Ontario's creative environment. Our highly skilled workforce, world-class education system and internationally recognized research community are all second to none. Our government invests in innovative companies like Xagenic so that our province's best ideas can flourish, create jobs and improve the lives of Ontarians, now and in the future," said Glen Murray, Minister of Research and Innovation and MPP for Toronto Centre.

In its first year of operation, Toronto-based Xagenic Inc. secured investments totalling more than $1-million from key organizations representing the research and commercialization community: MI, the Ontario Institute for Cancer Research, the Ontario Centre of Excellence (OCE) and The Health Technology Exchange. Today's provincial funding and an additional $200,000 commitment by OCE's Centre for Commercialization of Research brings Xagenic's total amount of secured investments to more than $2.2-million. Xagenic's establishment and the significant amount of investment raised in its first year of operation reflects MI's leadership in identifying and nurturing exciting inventions and ideas towards the marketplace.

Founded in 2010 and based in Toronto, life sciences company Xagenic Inc. is pioneering a leading-edge, chip-based diagnostic screening technology that uses nanotechnology-based microelectrodes. This technology, invented at the University of Toronto by renowned scientist and Professor Dr. Shana Kelley, is being developed to address a large clinical unmet need: rapid, on-demand, sample-to-answer detection of pathogens in less than 30 minutes.

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