TORONTO, Jan. 11 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced commercial availability of the ID-Tag(TM) RVP(x) (Respiratory Viral Panel) test. It is the first microarray-based diagnostic test for clinical evaluations that can rapidly identify and discriminate 21 respiratory viruses, including those associated with avian flu. The test is available worldwide for use in accordance with local regulatory requirements.
The test may be used with patients presenting with influenza-like symptoms, as well as by public health laboratories concerned with identifying and containing pandemic threats, such as avian flu.
“Major public health authorities such as the World Health Organization, have identified subtyping as an unmet need in current testing. Not knowing which subtype is involved in a given situation could lead to a failure to develop the correct response with serious consequences. For this reason, the ID-Tag(TM) RVP test incorporates the ability to carry out subtyping of influenza A strains including the specific H5 subtype associated with avian flu,” said Dr. Richard Janeczko, Chief Scientific Officer of Tm Bioscience.
“By covering such a broad range of respiratory viruses using the same universal array platform validated for existing Tm IVD products, the performance characteristics that will be established for this test should enable laboratories to have greater certainty with respect to both positive and negative results. It is expected to become a valuable tool in the diagnosis and management of respiratory infections and in public health applications,” said Greg Hines, President and CEO of Tm Bioscience. “We intend to continue clinical validation activities and advance this product through the IVD clearance process in North America and internationally.”
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. The Company has commercialized Analyte Specific Reagents(xx) and a series of Tag-It(TM) tests(x) 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 FDA as an in vitro device (IVD) for diagnostic use in the United States. It has also received the CE Mark, allowing the test to be marketed for diagnostic purposes in the European Union. 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 (Luminex Corporation, Austin, Texas), 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. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at www.tmbioscience.com.
(x) For Investigational Use Only. The performance characteristics of these products have not been established (xx) Analyte Specific Reagent. Analytical and performance characteristics are not established. Forward-Looking Statements
This press release contains forward-looking statements, which by their nature necessarily involve risk and uncertainties that could cause the actual results to differ materially from those contemplated by such statements. Tm Bioscience considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions readers that these assumptions may ultimately prove to be incorrect due to certain risks and uncertainties including, without limitation, the difficulty of predicting regulatory approvals, market acceptance and demand for new products, the availability of appropriate genetic content and other materials required for Tm Bioscience’s products, Tm Bioscience’s ability to manufacture its products on a large scale, the protection of intellectual property connected with genetic content, the impact of competitive products, currency fluctuations, risks associated with Tm Bioscience’s manufacturing facility and any other similar or related risks and uncertainties. If any of these risks or uncertainties were to materialize, or if assumptions underlying the forward- looking statements of management were to prove incorrect, actual results of Tm Bioscience could vary materially from those that are expressed or implied by these forward-looking statements. Tm Bioscience disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
The TSX Exchange has not reviewed and does not accept responsibility for
the adequacy or accuracy of this release.
Tm Bioscience
CONTACT: Investor Relations Contacts: Tm Bioscience - Canada: James Smith,The Equicom Group, Tel.: (416) 815-0700, Email: jsmith@equicomgroup.com; TmBioscience - U.S.: Sharon Weinstein, Account Supervisor, Euro RSCG LifeNRP, Tel.: (212) 845-4271, Email: sharon.weinstein@eurorscg.com; To requesta free copy of this organization’s annual report, please go tohttp://www.newswire.ca and click on Tools for Investors.