Tm BIOSCIENCE announces coagulation test validation with 100% concordance to DNA sequencing

Manufacturing facility on schedule for launch of Coagulation Mutation Detection assay in early 2003 

TORONTO, ON, November 5, 2002 — Tm Bioscience Corporation (TSX Venture: TMC) announced today positive results from the validation process of the Tm Tag-It™ Mutation Detection Kit for Coagulation. This validation was conducted using 132 patient samples provided by the Ottawa Health Research Institute and demonstrated that results obtained using the Tm Coagulation test were 100% accurate when compared to results obtained using slower, more expensive DNA sequencing methods. This test will be used to identify patients with an elevated risk of developing blood clots, an important factor when considering surgery, hormone replacement therapy or hormone-based birth control methods.

“This successful validation of our first genetic test is an affirmation of our ability to successfully design and develop low cost, fast, accurate tests to capture the emerging genetic testing market,” said Greg Hines, President and CEO of Tm Bioscience. “We anticipate launching this product in early 2003 as the first in a series, which will also include tests for cystic fibrosis, melanoma, and drug metabolism.”

The 6-mutation Coagulation assay by Tm Bioscience showed 100% accuracy compared with DNA sequencing on all 736 out of 736 mutations. Of note, not all mutations were used to calculate accuracy primarily due to ambiguous results provided by the older DNA sequencing method. A total of 517 wildtype, 185 heterozygous and 34 mutant calls were made from the 132 patient DNA samples used in the study. The Coagulation test was developed on the Tm Universal Array platform using the Luminex xMAP™ bead-based system. The Tm Universal Array platform provides the Coagulation test with the necessary flexibility to easily incorporate additional clinically relevant mutations as they are discovered. 

“The greatest potential to reduce venous thromboembolism (VTE) morbidity and mortality is prevention, however, current methods for identifying patients with genetic risk factors to VTE are slow, expensive, and laborious,” said Dr. Philip Wells of the Ottawa Health Research Institute. “Providing healthcare professionals with an affordable, accurate thrombophilia test will allow them and their patients to take advantage of preventive anticoagulant therapies and risk avoidance strategies.”

The Company also completed construction and initiated the process of outfitting and certifying its cGMP pilot-scale manufacturing facility. The facility has been designed to meet the physical requirements of the various international regulatory agencies and is on schedule for commercial production of the Tm Coagulation test. This facility will also be used for the production of other genetic tests in the Company’s development pipeline.

About Coagulation
Venous thromboembolism (VTE) or blood clotting in veins is a major worldwide health problem. Predisposition to VTE is strongly influenced by genetic factors, and approximately 10% of people of Northern European descent have a genetic profile associated with a 7-fold increased risk of the disease. The likelihood of VTE is even greater when combined with other risk factors such as oral contraceptive use, estrogen replacement therapy, pregnancy, major surgery or prolonged immobilization. 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.

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. The lead product from Tm Bioscience is the Tm100 Universal Array, a microarray “operating system” capable of combining any set of 100 single DNA tests and performing them simultaneously in a single reaction. The Tm100 universal microarray is accurate, fast, flexible, economical and suitable as an industry standard. 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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