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Celera's genotyping system software receives 510(k) clearance

Celera : 21 July, 2008  (New Product)
Celera has received marketing clearance from the US Food and Drug Administration for its 510(k) submission of the ViroSeq HIV-1 Genotyping System Software v2.8.
The ViroSeq HIV-1 Genotyping 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 (etravirine) and Prezista (darunavir) from Tibotec Therapeutics, a division of Ortho Biotech Products;

- An update of the resistance algorithm for all currently available protease and reverse transcriptase inhibitors; and,

- Support for the software on Intel-dual processor computers.

“The ViroSeq HIV-1 Genotyping System has become a standardised tool for physicians seeking the best course of drug treatment for HIV-1 infected individuals through monitoring of viral resistance,” said Michael Zoccoli, PhD, general manager of Celera’s Products business. “To ensure better management of HIV-1 infected patients, it is critical that we update our ViroSeq drug resistance algorithm to keep pace with new therapeutic interventions that optimize treatment of this life threatening disease.”

The efficacy of HIV-1 drug therapy is modulated by the mutation rate of the HIV-1 virus during drug treatment, which can lead to drug resistance and consequent therapeutic failure among individuals. Studies have found that a significant number of drug treated patients show signs of resistance to one or more drugs typically used to treat HIV. The rate of drug resistance among new cases is also increasing. Up to 15 percent of drug naive individuals newly diagnosed with HIV were infected with a strain that was already resistant to at least one antiretroviral drug.

Genotyping is a sequencing-based testing method that is routinely used by laboratories and clinicians throughout the world to determine the genetic composition of the HIV-1 virus. 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 provides 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.
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