Collaborative study to evaluate impact of genetic testing for warfarin
dosing on patient safety and financial savings
TORONTO, Jan. 30 /CNW/ - Tm Bioscience Corporation (TSX: TMC), a leader
in the commercial genetic testing market, today announced that its Tag-It(TM)
reagents for P450-2C9 and VKORC1 will be used in a comprehensive prospective
clinical study of patients using warfarin, a widely used blood thinner
initially marketed as Coumadin(R). The collaborative study between Medco
Health Solutions, Inc. (NYSE: MHS), a pharmacy benefits management company,
and Mayo Collaborative Services, Inc. will jointly evaluate the potential of
genetic testing to deliver cost-savings while improving patient safety and
care by reducing adverse drug reactions.
"Each year, approximately two million people in the United States begin
therapy with warfarin to prevent blood clots, however, as many as one in five
will suffer adverse events from mild to severe bleeding. Genetic testing can
provide valuable information about the rate at which patients will metabolize
the drug, helping physicians prescribe the most appropriate dose of the
medication for a particular patient," said Dr. Thomas Moyer, Medical Director
for Mayo Collaborative Services and the co-Primary Investigator for the trial.
Medco and Mayo will evaluate the genetic test results from more than
1,000 patients taking warfarin. The program is scheduled to begin enrolling
patients in the first quarter of 2007 and be complete by the end of that year.
"Companion testing for warfarin represents a significant near-term
opportunity within our pharmacogenetic test franchise," said Mr. Greg Hines,
President and CEO of Tm Bioscience. "We anticipate this study will highlight
the enormous potential for genetic testing to assist physicians in improving
outcomes for their patients."
About Mayo Medical Laboratories/The Department of Laboratory Medicine
The Department of Laboratory Medicine and Pathology at Mayo Clinic
maintains an active diagnostic test development program. This program also
incorporates discoveries from other diagnostic and biotechnology companies and
academic organizations. Mayo utilizes these proven diagnostic technologies in
the care of its patients and offers them to more than 3,500 health care
institutions around the world through Mayo Medical Laboratories. Revenue from
Mayo Medical Laboratories testing is used to support medical education and
research at Mayo Clinic. Mayo Collaborative Services, Inc. is the parent
Medco Health Solutions, Inc. (NYSE: MHS - News) is the nation's leading
pharmacy benefit manager based on its 2005 total net revenues of nearly
$38 billion. Medco's prescription drug benefit programs are designed to drive
down the cost of pharmacy health care for private and public employers, health
plans, labor unions and government agencies of all sizes, and for individuals
served by the Medicare Part D Prescription Drug Program. Medco's
technologically advanced mail-order pharmacies and award-winning Internet
pharmacy have been recognized for setting new industry benchmarks for pharmacy
dispensing quality. Medco serves the needs of patients with complex conditions
requiring sophisticated treatment through its specialty pharmacy operation,
which became the nation's largest with the 2005 acquisition of Accredo Health,
Incorporated. Medco is the highest-ranked pharmacy benefit manager on the 2006
Fortune 500 list. On the Net: http://www.medco.com.
About Tm Bioscience - Putting the Human Genome to Work(TM)
Tm Bioscience (TSX: TMC) is a Toronto-based diagnostics company
developing a suite of DNA-based tests for genetic disorders, drug metabolism
(pharmacogenetics) and infectious diseases. On December 14, 2006 Luminex
Corporation (NASDAQ: LMNX) and Tm Bioscience announced a definitive agreement
for Luminex to acquire Tm Bioscience.
Tm Bioscience has developed and commercialized Analyte Specific Reagents(*)
and a series of Tag-It(TM)(xx) tests for a variety of genetic disorders. These
tests are based on Tm Bioscience's Tag-It(TM) Universal Array platform, which
utilizes a proprietary universal tag system that allows for easy optimization,
product development and expansion.
Tm Bioscience's Cystic Fibrosis (CF) test is the first multiplexed human
disease genotyping test to be cleared by the FDA as an in vitro device (IVD)
for diagnostic use in the U.S. It has also received CE mark certification and
Health Canada clearance, allowing the test to be marketed for diagnostic
purposes in the European Union and Canada.
The ID-Tag(TM) Respiratory Viral Panel from Tm Bioscience is a reliable
and cost-effective test designed to play a key role in patient management,
infection control and in countering the pandemic threat of respiratory
diseases, all with results in less than six hours. The ID-Tag(TM) RVP has
received CE mark certification and the Company is focused on gaining
regulatory clearance from the FDA for the ID-Tag(TM) RVP as an in vitro device
(IVD) in the United States and is also working towards Health Canada approval.
The CE marked IVD product probes for 20 viral sequences and Tm is seeking a
license for an equivalent IVD product in Canada. In the United States, the IVD
application is for a product which excludes the SARS sequence.
In addition, the Company is developing a companion test for the
blood-thinning drug warfarin and a test for patients under treatment for
sepsis. For more information, visit http://www.tmbioscience.com.
(*) Analyte Specific Reagent. Analytical and performance characteristics
are not established.
(xx) For Investigational Use Only. The performance characteristics of
these products have not been established.
This press release contains information that is forward-looking
information within the meaning of applicable securities laws. In some cases,
forward-looking information can be identified by the use of terms such as
"may", "will", "should", "expect", "plan", "anticipate", "believe", "intend",
"estimate", "predict", "potential", "continue" or the negative of these terms
or other similar expressions concerning matters that are not historical facts.
Forward-looking information, by its nature necessarily involves risks and
uncertainties including, without limitation, the difficulty of predicting
regulatory approvals, the timing and conditions precedent to obtaining any
regulatory approval, market acceptance and demand for new products, the
availability of appropriate genetic content and other materials required for
the Company's products, the Company's ability to manufacture its products on a
large scale, the protection of intellectual property connected with genetic
content, the impact of competitive products, currency fluctuations, risks
associated with the Company's manufacturing facility, the risk that final
court approval for the arrangement transaction with Luminex will not be
obtained or the arrangement transaction will not close and any other similar
or related risks and uncertainties. Additional risks and uncertainties
affecting the Company can be found in the Company's 2005 Annual Report,
available on SEDAR at www.sedar.com and in the Company's Form 20-F, as
amended, filed with the U.S. Securities and Exchange Commission and available
at www.sec.gov. If any of these risks or uncertainties were to materialize, or
if the factors and assumptions underlying the forward-looking information were
to prove incorrect, actual results could vary materially from those that are
expressed or implied by the forward-looking information contained herein. The
Company disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
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