TORONTO, April 19 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced it has signed a distribution agreement with a major diagnostics distributor to commercialize the ID-Tag(TM) Respiratory Viral Panel (RVP) from Tm in Turkey.
"This is the first of a number of regional distribution agreements that we anticipate signing for our ID-Tag(TM) RVP, a unique test that has the potential to play a key role in managing the pandemic threat of Avian Flu in addition to its role as a tool to assist in the diagnosis of respiratory viruses in clinical settings," said Mr. Greg Hines, President and CEO of Tm Bioscience. "Turkey is on the front lines of the bird flu outbreak, suffering the first deaths from the disease outside of Southeast Asia and China. Our test will be marketed in one of the areas hardest hit so far, where we anticipate it will be used as a first line surveillance tool for suspected avian flu infections."
Tm anticipates the ID-Tag(TM) RVP will be launched in Turkey in the coming weeks. To further support marketing efforts outside of North America, Tm expects to obtain CE marking for this product in 2006."
The ID-Tag(TM) RVP is a comprehensive assay for the detection of various strains of viruses and subtypes, including H5 (Avian Flu). The Company expects that the ID-Tag(TM) RVP will address two key markets. First, it is expected to serve as a cornerstone diagnostic product in the clinical setting for the more efficient management and treatment of patients who may be infected by respiratory viruses. The product is also expected to play a key role in managing the potential pandemic threats posed by the Avian Flu and SARS, and the Company is actively promoting its adoption within the global public health community.
In January 2006, the Company made the ID-Tag(TM) RVP commercially available outside of the U.S. and for evaluation purposes within the U.S. To drive sales, Tm is establishing market presence by enabling key customers and thought leaders to gain experience with the test through an Early Access Program. The Company is also focused on gaining regulatory clearance for the test as an IVD and is undertaking validation studies to generate data for regulatory submissions in the first half of 2006. Tm's sales force will be directly marketing the product to hospital based laboratories in the U.S. and Canada. The Company is in discussion with additional distributors for selling the product outside of the U.S.
Tm Bioscience's product menu is focused in the fields of human genetic disorders, pharmacogenetics and infectious disease. The Company has commercialized Analyte Specific Reagents(x) and a series of Tag-It(TM) tests(xx) 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 U.S. Food and Drug Administration (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, 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.
(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.
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. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at www.tmbioscience.com.
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 these 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 in Turkey, its expected role as a cornerstone diagnostic product and as a tool to manage pandemic threats posed by Avian Flu and SARS, and the expected regulatory status for ID-Tag(TM) RVP in both Europe and the United States, are 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 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 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, particularly the Avian Flu and SARS. 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, 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. 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.