New HIV Genotyping System Approved By FDA

Thursday, March 1, 2001

New HIV Genotyping System Approved By FDA (NAPSA)—There’s encouraging medical news. A new genotyping system used to test whether people are resistant to the drugs prescribed to treat HIV wasrecently cleared for market by the U.S. Food and Drug Administration. The TRUGENE HIV-1 Genotyping Test and OpenGene DNA Sequencing System, from Visible Genetics Inc. (VGI: Nasdaq: VGIN)is the first HIV drug resistance test to receive clearance from the FDA. The clearance is considered a significant advance in the battle against HIV as it provides doctors with a reliable, accurate and easyto-use diagnostic tool to aid in therapeutic drug selection. The system was submitted to the FDA on September 5, 2000 as an “integrated system” comprised of the chemistry, hardware, software and interpretive patient, report necessary to generate tests results. “This is a milestone in HIV patient care,” said Richard T. Daly, President and CEO of Visible Genetics Inc. “The TRUGENE HIV-1 test will help improve treatment for HIV, becauseit is a standardized HIV resistance test that allows physicians to personalize therapy for each HIV-infected patient.” “Over 60 percent of patients worldwide havefailed initial HIV therapy,” according to John Stansell, MD, Acting Chief & Medical Director, Positive Health Program, University of California at San Francisco. “TRUGENEoffers Treating patients with HIV may now be easier thanks to a new discovery. physicians the opportunity to prescribe drugs, which will enable them to reestablish control of their patients’ HIV infection.” Visible Genetics’ technology is said to be the first step in personalized therapy, allowing the physician and patient to tailor therapy directly to that patient. The immediate applications are HIV but additional applications in the future are hepatitis C, hepatitis B and oncology. Visible Genetics Inc. is a leader in the emerging field of pharmacogenomics, which uses genetic information in the identification and analysis of genes to improve patient care and reduce healthcare costs. VGI manufactures and markets high performance automated DNA sequencing systems and complete kits for the analysis of genes linked to disease.

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