Tm Bioscience Signs Supply Agreement with Pharmacogenetics Diagnostic Laboratory

Tm Bioscience Corporation, an emerging leader in DNA-based diagnostic testing, announced today that it has entered into a two-year contract with the Pharmacogenetics Diagnostic Laboratory (PGx) of the University of Louisville Medical School to supply it with the Tag-It(TM) P450-2D6 Mutation Detection Kit. This kit identifies the presence or absence of important mutations common in patients with atypical drug metabolism, which can lead to adverse drug reactions (ADRs).

ADRs have been cited as one of the leading causes of death in the US[1]. Scientists estimate that P450-2D6-derived enzymes metabolize 20% of currently available prescription drugs.  The Tag-It(TM) Mutation Detection Kit for P450- 2D6 provides simultaneous detection of 12 mutations (24 alleles) and two gene rearrangements in a multiplex format.  The Tag-It(TM) P450-2D6 kit is a cost effective, high throughput assay that will improve the productivity of the
pharmacogenetic lab.

“PGx is one of the leading laboratories for pharmacogenetic testing, and we are pleased that our Tag-It(TM) P450-2D6 test meets the high standards of their scientists and laboratorians,” stated Greg Hines, CEO of Tm Bioscience. “This contract further validates the growing market for P450 testing and is in line with Tm’s strategy to focus on customers dedicated to bringing P450 testing into the mainstream of laboratory practice.”

“Currently, the assessment of drug metabolism mutations is frequently done through laboratory developed tests, which are not particularly accurate and have become increasingly less efficient as the volume of testing continues to rise,” explained PGx Lab’s Assistant Director, Mark Linder, PhD, DABCC, FACB. “The Tm Bioscience kit accurately detects mutations in the key alleles known to affect drug metabolism, providing both clinicians and physicians with critical information that they will be able to use in developing better tools for patient management.”

    1. JAMA 1998; 279:1200-1205

    About Tag-It(TM) genetic tests

Tm Bioscience’s product menu is focused in the fields of human genetic disorders, pharmacogenetics and infectious disease. The Company has already commercialized a series of Tag-It(TM) tests for coagulation genes, launched in December 2002; the Tag-It(TM) P450-2D6 test, first in a series of tests for drug metabolism genes; and the Tag-It(TM) CFTR 40+4 test, launched in September 2003. The Company’s pre-commercial pipeline includes the Tag-It(TM) P450-2C9 and P450- 2C19 drug metabolism gene tests and an Ashkenazi Jewish panel combining several common hereditary disease gene tests.  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 bead based instrument growing in popularity. Combined, the Universal Array and Luminex instrument enable the rapid production of flexible, highly accurate, high- throughput, low-cost DNA-based tests.

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 mutations related to hematology, cystic fibrosis, drug metabolism and other debilitating genetic disorders. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at www.tmbioscience.com .

About the Pharmacogenetics Diagnostic Laboratory — The Pharmacognetic Diagnostic Laboratory (PGx Lab) at the University of Louisville School of Medicine focuses on the study of the ways in which genetics affects medications. This scientific data provides caregivers the most accurate and timely pharmacogenetic tests and information possible to allow them to
radically decrease the risk of adverse drug reactions.  The staff has more than 45 years of experience in scientific research and clinical medicine. Additional information on the PGx Lab can be found at www.pgxlab.com .