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Roche Diagnostics' HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class of HIV Drug

Posted on: Monday, 29 October 2007, 12:00 CDT

INDIANAPOLIS, Oct. 29 /PRNewswire/ -- Merck's new integrase inhibitor, Isentress, approved last week by the Food and Drug Administration, used Roche Diagnostics' COBAS(R) HIV-1 AMPLICOR viral load test during its clinical trials.

The new HIV drug, generically known as Raltegravir, is an HIV integrase inhibitor. Integrase inhibitors prevent replication of the virus by blocking insertion of HIV genetic material into human DNA. There are several other HIV integrase inhibitor drugs under development.

Isentress clinical trials researchers followed patients' progress by testing their viral loads with Roche's COBAS(R)HIV-1 AMPLICOR viral load test, which targets the gag region of the HIV virus genome, a different area from the integrase region where many new drugs in the HIV pipeline are being developed. Viral load testing, which quantifies the amount of HIV RNA in a patient's blood, is critical for evaluating response to therapy and as an aid to optimize patient treatment.

"With this new drug classification, it's important to choose an assay that can accurately detect viral load," said Dr. Bill Valenti, founding medical director and staff physician for the AIDS Community Health Center in Rochester, NY. "We've seen evidence of how easily HIV can mutate. If the targeted region mutates during viral load monitoring, the virus may become difficult to detect and quantitate, which may lead to inaccurate information on patients' responses to treatment."

Twenty-one natural polymorphisms and 42 resistance mutations have been identified so far in the integrase region of the HIV genome, according to a 2007 peer reviewed study published in Antiviral Therapy.

Roche's HIV-1 viral load test has been the predominant choice in HIV anti- retroviral clinical drug trials since 1996. Roche has provided research and expertise in comprehensive diagnostic tests for developing HIV anti-retroviral drugs.

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche

employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our U.S. website at http://www.roche-diagnostics.us/.

All trademarks used or mentioned in this release are legally protected by law.

For further information please contact: Lori McLaughlin Corporate Communications Roche Diagnostics Corporation, Indianapolis, Ind. Phone: 317-521-3112 lori.mclaughlin@roche.com

Roche Diagnostics

CONTACT: Lori McLaughlin, Corporate Communications of Roche Diagnostics,+1-317-521-3112, or lori.mclaughlin@roche.com

Web site: http://www.roche.com/http://www.roche-diagnostics.us/

Source: PRNewswire

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