HIV-1 Genotyping System Premarket Notification Submitted to FDA

ALAMEDA, Calif., August 1 -— Celera Diagnostics, a joint venture of Applied Biosystems Group and Celera Genomics Group, both Applera Corporation businesses, announced that a 510(k) Premarket Notification has been submitted to the US Food and Drug Administration (FDA) seeking marketing clearance of the ViroSeq HIV-1 Genotyping System as an in vitro diagnostic product. This submission was filed by Applied Biosystems.

Pending receipt of marketing clearance from the FDA, Applied Biosystems will have marketing responsibility for the product. The FDA has advised that the submission has been received and assigned a reference number. Celera Diagnostics and Applied Biosystems expect to work closely with the FDA to follow the accelerated de novo review process of the FDA Modernization Act of 1997 for the clearance of low-risk, class II devices, which have no substantially equivalent predicate device already on the market.

The ViroSeq system is designed to detect drug resistance in the HIV-1 virus genome. "The HIV-1 virus mutates rapidly, which greatly compromises the efficacy of drug regimens," said Eric D. Shulse, director of molecular diagnostics at Celera Diagnostics. "We believe that genotyping with the ViroSeq HIV-1 Genotyping System will be a useful tool in identifying drug resistance in the HIV-1 genome. With this information, physicians could in the future be able to prescribe treatment regimens that might be precisely tailored to the type of HIV-1 drug-resistant strain infecting the patient."