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Article: FDA Grants Clearance for Celera's ViroSeq(R) HIV-1 Genotyping System Software v2.8.
- Article from:
- Business Wire
- Article date:
- July 18, 2008
CopyrightCOPYRIGHT 2008 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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ALAMEDA, Calif. -- Celera (NASDAQ:CRA) today announced that it has received marketing clearance from the U.S. Food and Drug Administration 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 ...