US firm submits HIV-1 drug resistance test to FDA:
This article was originally published in Clinica
Executive Summary
Applied Biosystems has submitted a 510(k) marketing application to the US FDA for its genotyping system for detecting drug resistance in the HIV-1 virus genome. The ViroSeq system targets protease and reverse transcriptase genes in the HIV-1 virus that spontaneously develop drug-resistance mutations at a rapid rate, says the Foster City, California firm.