FDA approves Celera’s HIV genotyping system

The Food and Drug Administration on Wednesday approved the ViroSeq HIV-1 Genotyping System, developed by Celera Diagnostics, for the detection of mutations in HIV's viral genome that convey resistance to anti-HIV medications. "We believe the ViroSeq HIV-1 Genotyping System can be a valuable tool for physicians seeking the best course of treatment for HIV-infected individuals," said Celera president Kathy Ordonez. "While HIV genotyping has become routine practice in the selection of drug therapy regimens to fight this disease, testing methods have yet to become standardized. The ViroSeq system, with its combination of FDA-cleared algorithms and reagents, has the potential to become a standard among clinical testing laboratories." The tests will be manufactured by Celera and distributed by Abbott Diagnostics.