TORONTO, July 19 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced it has signed a distribution agreement with RAMCON A/S (Birkerod, Denmark) to commercialize the ID-Tag(TM) Respiratory Viral Panel (RVP) from Tm in Denmark, Sweden, Finland and Norway. The ID-Tag RVP detects 20 respiratory viruses and subtypes including Avian Flu and SARS.
"We continue to make great progress in securing a commercial distribution footprint across Europe for our Respiratory Viral Panel in anticipation of regulatory clearance," said Mr. Greg Hines, President and CEO of Tm Bioscience. "RAMCON is a well established distributor of the Luminex platform on which our test operates, making them an ideal distributor for our product."
Under terms of the agreement, RAMCON will have the exclusive right to market and sell the ID-Tag Respiratory Viral Panel in Denmark, Sweden, Finland and Norway. Tm will supply RAMCON with finished packaged product and will receive revenue from the sale of such finished packaged product.
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. The 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 RAMCON A/S
Ramcon A/S, established in 1988, is a leading distribution company based in Denmark which supplies products for research and diagnostics to universities, hospitals, research institutes, pharmaceutical and biotechnology companies in Sweden, Denmark, Norway and Finland.
The company is a full-service distributor of Luminex instruments and reagents in these countries.
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 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.
(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.
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 receive regulatory approval for the ID-Tag(TM) RVP from the FDA in 2006. 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 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.