TORONTO, June 30 /PRNewswire-FirstCall/ -- Tm Bioscience , a leader in the commercial genetic testing market, today announced that to date more than 25 leading healthcare institutions and laboratories across North America, Europe and Asia have entered its Early Access Program to assess the ID-Tag(TM) Respiratory Viral Panel (RVP), a unique test that has the potential to play a key role both in the management of patients exhibiting respiratory distress in clinical settings and in countering the pandemic threat of respiratory viruses.
“Healthcare institutions around the world will benefit significantly from a test that can rapidly and reliably identify patients infected with respiratory viruses. Our panel will be evaluated in a variety of prestigious high-volume healthcare facilities that will provide us with important feedback, ensuring our test fully addresses their needs and is marketed effectively,” said Mr. Greg Hines, President and CEO of Tm Bioscience. “These institutions will also be able to gain experience with the ID-Tag RVP, allowing them to implement the test rapidly once it completes the regulatory approval process.”
Michael Mihalov, MD, Chair of Pathology and Director of the Diagnostic Molecular Pathology Lab at Resurrection Medical Center, one of the institutions participating in the Early Access Program, said he expects the ID-Tag(TM) RVP to prove advantageous in testing for various respiratory viruses quickly, economically and accurately. “Our lab has had great success with Tm Bioscience products, and we are anxious to evaluate their respiratory panel. Current respiratory viral testing is time-consuming and inconvenient for a high-volume hospital serving thousands of patients in a large metropolitan area. ID-Tag RVP will help us identify respiratory viruses more rapidly and undertake appropriate intervention, whether that is treatment or isolation,” Mihalov said.
Early access partners include community hospitals, pediatric hospitals, reference laboratories and public health labs such as the Alberta Provincial Lab for Public Health (ProvLab) in Calgary, AB, a leader in the area of molecular testing for respiratory viruses.
The Tm Bioscience ID-Tag(TM) Respiratory Viral Panel (RVP)
Tm Bioscience’s ID-Tag RVP is a proprietary, comprehensive test for the detection of 20 of the most common strains and subtypes of respiratory viruses, including respiratory syncytial virus A and B, influenza A (with subtyping) and influenza B. ID-Tag RVP is designed to play a key role in patient management, infection control and in countering the pandemic threat of respiratory diseases.
Tm Bioscience is focused on gaining regulatory clearance from the FDA for ID-Tag RVP as an in vitro device (IVD) in the United States, and is also working towards Health Canada approval and CE marking in Europe. All submissions are currently on track.
In January 2006, Tm Bioscience made the ID-Tag RVP commercially available as an IUO (Investigational Use Only) device. Most recently, the Company has signed distribution agreements for ID-Tag RVP in the Netherlands and in Turkey. Tm anticipates securing additional distribution agreements for the product with the goal of making the test available globally.
About Resurrection Health Care
Resurrection Medical Center is part of Resurrection Health Care, a family of health care services providing advanced medical care and exceptional customer service with compassion and hope. The Resurrection hospitals, nursing homes, retirement communities, home health services, behavioral health programs and other services are conveniently located throughout Chicago’s neighborhoods. Resurrection Health Care is a not-for-profit Catholic organization sponsored by the Sisters of the Holy Family of Nazareth and the Sisters of the Resurrection. For more information, visit http://www.reshealth.org .
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* and a series of Tag-It(TM)** tests for a variety of genetic disorders. These tests are based on Tm Bioscience’s proprietary 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, allowing the test to be marketed for diagnostic purposes in the European Union. 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 tmbioscience.com . * Analyte Specific Reagent. Analytical and performance characteristics are not established. ** 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 both Europe and the United States, 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 it will submit ID-Tag(TM) RVP to the FDA for regulatory approval in the first half of 2006, and that it will receive the necessary approval in the same year. The Company has also assumed that ID-Tag(TM) RVP will receive CE marking in Europe coincident with the U.S. FDA approval, that it 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 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 http://www.sedar.com . 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
CONTACT: Jeremy Bridge-Cook of Tm Bioscience, +1-416-593-4323 x229,jbridgecook@tmbioscience.com; or PR Contact, Karl Schmieder of GCI Group,+1-212-537-8047 or +1-646-515-3392, kschmieder@gcigroup.com; or InvestorRelations Contact, James Smith of The Equicom Group, +1-416-815-0700,jsmith@equicomgroup.com, both for Tm Bioscience
