Tm BIOSCIENCE LAUNCHES COAGULATION GENETIC TESTS
- Menu of tests for coagulation disorders launched ahead of schedule-
TORONTO, ON, December 4, 2002 — Tm Bioscience Corporation (TSX Venture: TMC) announced today the
launch, ahead of schedule, of 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.
The Tag-It™ coagulation tests can be ordered directly from Tm Bioscience by calling 1 (800) 593-2370.
About Tm Tag-It™ Mutation Detection Kit for coagulation The Tag-It™ Mutation Detection Kit for coagulation provides healthcare professionals with an affordable, accurate test
to identify patients with genetic risk factors for venous thromboembolism (VTE) including deep
vein thrombosis (DVT) and pulmonary embolism (PE). These conditions , involving blood clotting in veins are a major worldwide health problem.
VTE leading to pulmonary embolism was the cause of death for some 175,000 North Americans last year and is the
leading cause of maternal death associated with childbirth. Identifying patients with elevated risk factors for VTE
including DVT may allow them to take advantage of preventive anticoagulant therapies and risk avoidance strategies.
Predisposition to VTE is strongly influenced by genetic factors, and approximately 10% of people of Northern European
descent have a genetic profile associated with up to a 7-fold increase in risk for the disease. The absolute likelihood of
VTE is even greater when combined with other risk factors such as oral contraceptive use, hormone replacement
therapy (HRT), pregnancy, major surgery or prolonged immobilization.
Genetic testing offers the potential to identify people at risk of morbidity and mortality from VTE and start them on a
prevention program. Current testing methods however are slow, expensive, and laborious. The Tag-It™ coagulation test
has demonstrated 100% concordance when compared to results obtained using slower, more expensive but highly
accurate DNA sequencing. The Company’s genetic tests are developed on the Tm Universal Array platform using the
Luminex xMAP™ bead-based system. The Tm Universal Array platform provides the Tag-It™ coagulation test with
the necessary flexibility to easily incorporate additional clinically relevant mutations as they are discovered.
The Tag-It™ Mutation Detection Kit for coagulation is currently being marketed as a “Research Use Only ” kit. Under
the provisions of the Clinical Laboratories Improvement Act, as amended, clinical laboratories may purchase this kit for
validation in their own laboratories under the “home brew” provisions of the Act. The FDA has not reviewed this test
and no claims for medical utility or test performance are being made. The relationships between the various mutations
detected by this kit are supported by literature only. No claims regarding the medical linkage of these mutations to VTE
or DVT should be inferred from the information provided.
About Tm Bioscience – Putting the Human Genome to Work™
Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests. Tm Bioscience’s product
pipeline includes tests for genetic mutations related to hematology, cystic fibrosis, toxicology and other debilitating
genetic disorders. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be
found at www.tmbioscience.com.
CONTACT:
Alan Coley James Smith
Vice President, Investor Relations Investor and Media Inquiries
416-593-4323 ext.237 416-815-0700 ext.229
416-593-1066 fax 416-815-0080 fax
acoley@tmbioscience.com jsmith@equicomgroup.com
INVESTOR RELATIONS CONTACT:
James Smith
The Equicom Group Inc.
416-815-0700 ext.229
jsmith@equicomgroup.com
www.tmbioscience.com
www.equicomgroup.com
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