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Tm Bioscience signs Turkish distribution agreement for Respiratory Viral Panel
Toronto, Ontario | Monday, April 24, 2006, 08:00 Hrs  [IST]

Tm Bioscience Corporation, a leader in the commercial genetic testing market, has signed a distribution agreement with a major diagnostics distributor to commercialize the ID-Tag Respiratory Viral Panel (RVP) from Tm in Turkey, a company release said.

"This is the first of a number of regional distribution agreements that we anticipate signing for our ID-Tag 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 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 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 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 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 RVP commercially available outside of the US and for evaluation purposes within the US. 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 Programme. 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 US and Canada. The company is in discussion with additional distributors for selling the product outside of the US.

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* and a series of Tag-It tests for a variety of genetic disorders. The company's Tag-It Cystic Fibrosis (CF) Kit is the first multiplexed human disease genotyping test to be cleared by the US 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 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 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.

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