FDA Grants Clearance For Celera's ViroSeq® HIV-1 Genotyping System Software V2.8

Main Category: HIV / AIDS
Also Included In: IT / Internet / E-mail;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 21 Jul 2008 - 2:00 PDT

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Celera (NASDAQ:CRA) 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™ 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, L.P.;

-- 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 standardized tool for physicians seeking the best course of drug treatment for HIV-1 infected individuals through monitoring of viral resistance," said Michael Zoccoli, Ph.D., 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% 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.

About Celera

Celera is a healthcare business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through its strategic alliance with Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer and liver diseases. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.

Forward-Looking Statements

Certain statements in this press release, including the Outlook section, are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "should," "anticipate," and "intend," among others. These forward-looking statements are based on Celera's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Celera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. The risks and uncertainties that may affect the operations, performance, development, and results of Celera's business include but are not limited to: 1) the risk that certain raw materials and equipment required may not be available or may not be available at acceptable prices; (2) potential product liability or other claims against Celera as a result of the testing or use of its products; and (3) other factors that might be described from time to time in Celera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Copyright© 2008. Celera Corporation. All Rights Reserved. Celera is a registered trademark of Celera Corporation or its subsidiaries in the U. S. and/or certain other countries

Source:
http://www.celera.com