Trugene OK'd by FDA
December 2001/January 2002
A test to gauge resistance to HIV drugs has been cleared for marketing by the Food and Drug Administration.
Trugene HIV-1 Genotyping Kit and OpenGeneDNA Sequencing System, developed by Visible Genetics Inc., was submitted to the FDA as an integrated system including chemistry, hardware, software and patient report necessary to generate test results. The report offers a health care provider information regarding antiretroviral drugs that are likely to be effective in the treatment of HIV infection.
The test allows physicians to personalize therapy for individual HIV patients, said Richard Daly, President and CEO of Visible Genetics Inc.
This test is intended to be used by health care providers as a tool for the management of HIV disease and in combination with all clinical and laboratory findings as well as the prescribed medication.
For additional information on the product, visit www.visgen.com.
This article was provided by AIDS Project Los Angeles. It is a part of the publication Positive Living.