FDA Grants Market Clearance of Visible Genetics' HIV Genotyping System
Press release from Visible Genetics
TRUGENE(TM) HIV-1 Genotyping Kit is First FDA Cleared DNA Sequence-Based Test
For HIV Drug Resistance Testing
TORONTO, Sept. 26 /PRNewswire/ -- Visible Genetics Inc. (Nasdaq: VGIN) (VGI) today received clearance from the U.S. Food and Drug Administration (FDA) to market its TRUGENE(TM) HIV-1 Genotyping Kit and OpenGene(TM) DNA Sequencing System for routine clinical use, becoming 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 treating physicians with a reliable, accurate and easy-to-use diagnostic tool to aid in therapeutic drug selection.
The TRUGENE HIV-1 Genotyping Kit and OpenGene 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 test results. The report provides information to the physician about which antiretroviral drugs are likely to be effective in treating the HIV infection of an individual patient.
"This is a milestone in HIV patient care," said Richard T. Daly, President and CEO of Visible Genetics. "TRUGENE is the first product of its kind that has been cleared by the FDA to offer simplified genetic testing technology allowing physicians to personalize therapy for each individual HIV patient. The immediate applications are in HIV but additional applications in the future are hepatitis C, hepatitis B and oncology."
The TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System is intended for use in detecting HIV genomic mutations (in the protease and part of the reverse transcriptase regions of HIV) that confer resistance to specific types of anti-retroviral drugs, as an aid in monitoring and treating HIV infection. It is intended for use as an aid to qualified clinicians in the therapeutic management of HIV-1 infected patients in conjunction with all relevant clinical and laboratory findings and the prescribing information of the drugs in question.
"Initial HIV drug therapy has failed in over 60 percent of patients worldwide who are under active antiretroviral drug treatment," according to John Stansell, MD, Acting Chief & Medical Director, Positive Health Program, University of California at San Francisco. "TRUGENE offers physicians the opportunity to prescribe drugs, which will enable them to reestablish control of their patients' HIV thereby improving their quality of life."