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Vancouver,
BC--There has been a lot of hype about "personalized medicine"
in recent years, unfortunately, little has been delivered.
Now things are changing, Greg Hines, president and CEO of Tm Bioscience
Corporation, Toronto, told dermatologists at Dermatology Update
2004.
Last year, the U.S. Food and Drug Administration told the pharma
industry that it wants to see genetic data on all new drug submissions.
Guidelines are being developed for mandatory reporting. In particular,
the FDA is interested in data on the cytochrome P-450 enzyme system,
responsible for drug metabolism.
"DNA testing will become a norm in medical offices in 10 years,"
Mr. Hines said. "Ten to 20 per cent of all hospital admissions
in Canada are due to adverse drug events."
Tm Bioscience, working in conjunction with Dr. David Hogg at the
University of Toronto, is considered a leader in the field. It currently
has three of its cytochrome P-450 assays on trial at the Mayo Clinic
in Rochester. The only other company that has a regulated assay
on the market is Roche, and it is available only in Europe at this
time.
Using Multiplex PCR, Tm Bioscience is able to run 94 patient results
on a single plate. For example, a low-cost genetic assay is available
for the identification of melanoma risk. The test screens for the
34 most common mutations on the p16 gene, found in 25 per cent of
familial melanoma.
Physicians can get results within three hours at a cost of $50 per
patient.
In the pipeline is a test for methicillin-resistant Staphylococcus
aureus. DTC
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