Celera (CRA) Receives FDA Clearance for ViroSeq(R) HIV-1 Genotyping System Software
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Celera (NASDAQ: CRA) today announced that it has received marketing clearance from the U.S. FDA for its 510(k) submission of the ViroSeq HIV-1 Genotyping System Software v2.8. The ViroSeq HIV-1 Genotyping(TM) System is designed to detect mutations in the HIV-1 viral genome that confer drug resistance, and as such, is used as an aid in monitoring and treating HIV-1 infections.
Features of the updated software include:
- The addition in the resistance algorithm of two new drugs, INTELENCE(TM) (etravirine) and PREZISTA(TM) (darunavir) from Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.;
- An update of the resistance algorithm for all currently available protease and reverse transcriptase inhibitors; and,
- Support for the software on Intel(R)-dual processor computers.
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