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news.Celera has received marketing clearance from the FDA for its 510-k submission of the ViroSeq HIV-1 Genotyping System Software v2.8.
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The ViroSeq HIV-1 genotyping system is said to be 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.
According to the company, the ViroSeq System consists of an automated DNA sequencing platform, reagents and dedicated software used to genotype strains of the HIV-1 virus that infect the patient. The system targets specific regions of the viral genome that can develop drug-resistant mutations.
ViroSeq’s high throughput processing is said to provide an integrated system from sample preparation to the final interpretive resistance report to aid the physician in drug treatment decisions.
The ViroSeq HIV-1 Genotyping System is manufactured by Celera, and is distributed by Abbott Laboratories.