Tm Bioscience Corporation Respiratory Viral Panel Selected By U.S. Navy
Published: Dec 14, 2006
TORONTO, Dec. 13 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced that its ID-Tag(TM) Respiratory Viral Panel (RVP), a proprietary, comprehensive test for the detection of the majority of strains and subtypes of respiratory viruses, including respiratory syncytial virus A and B, influenza A (with subtyping) and influenza B, will be evaluated by a U.S. Navy research laboratory.
The ID-Tag(TM) RVP will be used to establish a comprehensive public health surveillance program in countries in the South East Asia region. In collaboration with regional health authorities, the U.S. Navy research laboratory will conduct infectious diseases surveillance activities using the ID-Tag(TM) RVP to focus on detection of acute respiratory pathogens including avian influenza.
"We are delighted that our test will be thoroughly evaluated by a key player in the global effort to manage potential pandemics. The multi-virus panel will be evaluated as a first line surveillance tool in one of the areas at highest risk for pandemics," said Mr. Greg Hines, President and CEO of Tm Bioscience. "This is an important step in our strategy to make the ID-Tag(TM) RVP product a worldwide standard for use in public health programs as well as for use in patient and resource management in clinical environments."
The Tm Bioscience ID-Tag(TM) Respiratory Viral Panel (RVP) - Differential
Diagnosis Made Easy
The ID-Tag(TM) RVP from Tm Bioscience is a reliable and cost-effective test designed to play a key role in patient management, infection control and in countering the pandemic threat of respiratory diseases, all with results in less than six hours.
The ID-Tag(TM) RVP has received CE mark certification and the Company is focused on gaining regulatory clearance from the FDA for the ID-Tag(TM) RVP as an in vitro device (IVD) in the United States and is also working towards Health Canada approval. The CE marked IVD product probes for 20 viral sequences and Tm is seeking a license for an equivalent IVD product in Canada. In the United States, the IVD application is for a product which excludes the SARS sequence.
In January 2006, Tm Bioscience made the ID-Tag(TM) RVP commercially available as an IUO (Investigational Use Only) device. Most recently, the Company has signed distribution agreements for ID-Tag(TM) RVP in the Netherlands, Scandinavia, Greece and Turkey. Tm anticipates securing additional distribution agreements for the product with the goal of making the test available globally.
For more information, visit the newly launched ID-Tag(TM) website, www.idtag.tmbioscience.com. About Tm Bioscience - Putting the Human Genome to Work(TM)
Tm Bioscience is a Toronto-based diagnostics company developing a suite of DNA-based tests for genetic disorders, drug metabolism (pharmacogenetics) and infectious diseases.
Tm Bioscience has developed and commercialized Analyte Specific Reagents(x) and a series of Tag-It(TM)(xx) tests for a variety of genetic disorders. These tests are based on Tm Bioscience's Tag-It(TM) Universal Array platform, which utilizes a proprietary universal tag system that allows for easy optimization, product development and expansion.
Tm Bioscience's Cystic Fibrosis (CF) test 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 U.S. It has also received CE mark certification and Health Canada clearance, allowing the test to be marketed for diagnostic purposes in the European Union and Canada.
In addition, the Company is developing a companion test for the blood-thinning drug warfarin and a test for patients under treatment for sepsis. For more information, visit http://www.tmbioscience.com.
(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. Forward-Looking Statements
This press release contains information that is forward-looking information within the meaning of applicable securities laws. In some cases, forward-looking information can be identified by the use of terms such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "intend", "estimate", "predict", "potential", "continue" or the negative of theses terms or other similar expressions concerning matters that are not historical facts. In particular, statements about the timing of the anticipated launch of ID-Tag(TM) RVP, its expected role as a cornerstone diagnostic product and as a tool to manage pandemic threats and the expected regulatory status for ID-Tag(TM) RVP in the United States and Canada, are or involve forward-looking information.
Forward-looking information is based on certain factors and assumptions. In particular, in making the statements in this press release, the Company has assumed that the ID-Tag(TM) RVP will receive U.S. FDA approval in 2006 or early 2007, that the Company will be able to develop and manufacture sufficient quantities of its ID-Tag(TM) RVP and that market penetration of ID-Tag(TM) RVP will be such that it will serve a key role in the management and treatment of patients infected by respiratory viruses. While the Company considers these assumptions to be reasonable based on information currently available to it, they may prove to be incorrect.
Forward-looking information, by its nature necessarily involves risks and uncertainties including, without limitation, the difficulty of predicting regulatory approvals, the timing and conditions precedent to obtaining any regulatory approval, market acceptance and demand for new products, the availability of appropriate genetic content and other materials required for the Company's products, the Company'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 the Company's manufacturing facility, the risk that the Company's current process to explore strategic alternatives will result in a transaction and any other similar or related risks and uncertainties. Additional risks and uncertainties affecting the Company can be found in the Company's 2005 Annual Report, available on SEDAR at www.sedar.com and in the Company's Form 20-F, as amended, filed with the U.S. Securities and Exchange Commission and available at www.sec.gov If any of these risks or uncertainties were to materialize, or if the factors and assumptions underlying the forward-looking information were to prove incorrect, actual results could vary materially from those that are expressed or implied by the forward-looking information contained herein. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Tm Bioscience
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