Genotyping

FDA clears Visible Genetics next generation HIV resistance interpretation software

Published in AIDS Weekly, May 27th, 2002

Visible Genetics, Inc., (VGIN) (VGI) received clearance from the U.S. Food and Drug Administration (FDA) for the next generation interpretation software for the TRUGENE HIV-1 Genotyping Test. The GuideLines 5.0 Rules, which include the latest data on HIV drug resistance, were reviewed within 30 days of the application being received.

"This is extremely encouraging for both physicians and patients," said Richard D'Aquila, professor of medicine at the Vanderbilt University in Nashville, Tennessee. "HIV resistance is so complex and our knowledge is changing so fast, it is critical that HIV resistance testing is conducted using technology that is both fully validated and...

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Source: AIDS Weekly (2002-05-27)

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