Tm Bioscience Corporation has launched its first genetic test products. The Tag-It Mutation Detection Kits for coagulation will be used to identify patients with an elevated risk of developing blood clots, an important factor when considering surgery, hormone replacement therapy (HRT) or hormone-based birth control methods. The Tag-It Mutation Detection line of products offers a cost effective, high throughput system with demonstrated accuracy as compared to results obtained using current testing methods.
"The speed with which we were able to design, develop and validate our first genetic test exceeded our own expectations, allowing us to launch ahead of schedule," said Greg Hines, President and CEO of Tm Bioscience. "We will continue to focus on the rapid commercialization of additional genetic tests to provide diagnostic laboratories with a full menu of genetic tests to offer their customers."
Over the coming months, the Company's target customer base, large commercial diagnostic laboratories, will have the opportunity to internally validate the Tag-It coagulation tests and evaluate Tm's technology. In order to maximize their investment in equipment and training, these laboratories are ultimately seeking a genetic testing platform that offers a menu of genetic tests. Accordingly, over the next year Tm Bioscience will launch an initial series of tests that also includes tests for cystic fibrosis and drug metabolism, with additional tests to follow. The Company's initial commercialization efforts include enabling market leaders to gain early experience with Tm's technology, towards encouraging their adoption of the broader menu of products that will be available later in 2003.
DNA testing for thrombophilia (coagulation disorders) is currently one of the highest volume genetic tests being performed in the U.S. and Europe, and the market is growing at greater than 50% annually. In addition, the market for this product category could grow substantially larger if testing prior to prescribing hormone replacement therapy or the birth control pill becomes standard practice. As such, Tm Bioscience believes that the market potential of its Tag-It coagulation tests over the next five years is significant.
The flexibility of the Tm Universal Array technology has allowed the Company to quickly and cost-effectively develop three versions of the Tag-It coagulation test in response to customer requests. The test, initially designed to identify mutations in Factor V Leiden, Factor II (prothrombin) and the two most common mutations in the MTHFR gene, will also be available as a test for Factor V Leiden and Factor II only, and as a test for Factor V Leiden only. Each version of the test is tailored to meet the needs of a unique segment of the diagnostic market.