TORONTO, Nov. 2 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced that it has developed an upper respiratory viral panel that detects all of the major human respiratory viruses, including H5N1 (Avian Flu) and SARS Corona. The test was developed within the framework of a collaboration with researchers in Dr. Jim Mahony’s lab at McMaster University in Hamilton, Ontario, Canada that was announced on May 9th of this year. The prototype is currently undergoing optimization and will begin clinical evaluation in the coming weeks. Tm is in discussions with regulators, including the FDA, on preparing IVD submissions for expedited review.
“I am very excited about this new test and its ability to rapidly detect all major human respiratory viruses including Avian Flu and SARS corona. This now makes it possible to replace conventional lab tests, which are laborious and often take several days or weeks to produce a definitive result. It provides physicians with a diagnosis much earlier than conventional tests thereby improving patient management for infected individuals. More importantly however, this test could play a major role during an outbreak or epidemic by clearly identifying infected individuals early in the outbreak and limiting the spread of virus in the community. The test will also assist public health authorities to avoid false alarms by determining which specific virus, if any, is present in a patient who is presenting flu symptoms,” said Dr. Jim Mahony, Director of the McMaster University Regional Virology and Chlamydiology Laboratory and President of the Pan American Society for Clinical Virology. Dr. Mahony’s lab played a major role in the development of the test by providing the genetic sequences for the probes and primers to build the test and assisted in establishing key test parameters for the detection of the individual viruses. His lab continues to work with Tm Bioscience to assess performance characteristics of the test using clinical specimens.
Tm Bioscience plans to launch successive versions of its Upper Respiratory Infectious Disease Panel over time. The first version of the panel, which detects and differentiates among various strains of Respiratory Syncitial Virus (RSV), SARS Corona Virus, Parainfluenza and Influenza Virus A/B including H5N1 (Avian Flu), is undergoing optimization and will be available for evaluation by hospital based laboratories and reference laboratories in early December. Subsequent versions of the test will be expanded to include additional viruses and may identify specific mutant variants of the H5N1 virus that are capable of human-to-human transmission or that develop Tamiflu(R) resistance.
“Each year our public health system is challenged with a wide and ever-changing variety of viral infections. Our Tag-It(TM) technology is a proven and flexible platform ideally suited for rapid and accurate detection of specific viral strains in a clinical setting,” said Greg Hines, President and CEO of Tm Bioscience. “With the critical need for tools to identify and contain the spread of novel virus strains that threaten to become epidemics, we have accelerated our development program for this product significantly and have commenced discussions with regulators, including the FDA, about submissions for expedited review.”
Luminex CEO, Patrick Balthrop commented, “We congratulate Tm Bioscience on the creation of another xMAP(R)-based product. Their assay development and molecular diagnostics expertise are rapidly providing customers with solutions to several emerging and important clinical challenges, like Avian flu. We’re proud to be their technology of choice for multiplexing.”
The test was developed using the Tag-It(TM) Universal Array platform from Tm Bioscience, which enables the rapid production of flexible, high-throughput, low-cost gene-based tests. The test operates on the Luminex xMAP(R) system (Luminex Corporation, Austin, Texas), a well-established instrument found in many clinical laboratories.
About Tag-It(TM) reagents and genetic tests
Tm Bioscience’s product menu is focused in the fields of human genetic disorders, pharmacogenetics and infectious disease. The Company has commercialized Analyte Specific Reagents(x) and a series of Tag-It(TM) tests(xx) for a variety of genetic disorders. The Company’s Tag-It(TM) Cystic Fibrosis (CF) Kit is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device (IVD) for diagnostic use in the United States. All genetic tests from Tm Bioscience are based on the Tag-It(TM) Universal Array platform, which utilizes a proprietary universal tag system that allows for easy optimization, product development and expansion. Assays from Tm operate on the Luminex xMAP(R) system, a well-established bead based instrument. Combined, the Universal Array and Luminex instrument enable the rapid production of flexible, high-throughput, low-cost DNA-based tests.
(x) Analyte Specific Reagent. Analytical and performance characteristics are not established. (xx) For Investigational Use Only. The performance characteristics of these products have not been established About Tm Bioscience - Putting the Human Genome to Work(TM)
Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests. Tm Bioscience’s product pipeline includes tests for genetic disorders, drug metabolism, and infectious diseases. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at www.tmbioscience.com.
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CONTACT: INVESTOR RELATIONS: Tm Bioscience - Canada, James Smith, TheEquicom Group, Tel.: (416) 815-0700, Email: jsmith@equicomgroup.com; TmBioscience - U.S., Sharon Weinstein, Euro RSCG Life NRP, Tel.: (212)845-4271, Email: sharon.weinstein@eurorscg.com; To request a free copy ofthis organization’s annual report, please go to http://www.newswire.ca andclick on Tools for Investors.