US OK's ViroSeq for use in larger laboratories:
This article was originally published in Clinica
Executive Summary
Celera Diagnostics has received US FDA 510(k) clearance to use its ViroSeq HIV-1 genotyping system with the ABI PRISM 3700 DNA analyser, a fully automated instrument commonly used in the largest, high-throughput clinical testing laboratories. The ViroSeq system, which detects mutations in the HIV-1 virus that are associated with drug resistance, is already cleared for use with analysers aimed at small and mid-sized throughput centres, according to the Alameda, California firm. It is distributed exclusively by Abbott Laboratories.