25 Leading Healthcare Institutions and Clinical Laboratories to Evaluate tm Bioscience's Test for Respiratory Viruses
Early Access Program to test unique product that can identify 20 respiratory viruses
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m Bioscience 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.
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