Updated PCR-Based Tests for HIV-1 and Hepatitis C Virus Approved by the FDA
Roche Diagnostics’ automated sample preparation combined with automated amplification and quantification of viral RNA assists laboratories’ operational efficiencies

Roche Diagnostics announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its new HIV-1 molecular diagnostic test system. This updated system, the COBAS AmpliPrep / COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 is the first PCR-based test offering fully automated specimen preparation followed by fully automated amplification and quantification of the HIV-1 RNA for viral load monitoring.

“These FDA approvals for tests on the COBAS AmpliPrep instrument demonstrate how Roche Diagnostics is realizing its vision for developing the ‘next generation’ of PCR innovation, and offers the opportunity for additional virology testing on the same platform in the future,” said Tiffany Olson, President and Chief Executive Officer, Roche Diagnostics Corporation. “At Roche Diagnostics we are continually focused on creating newer and better means for improving the functional value and acceptance of molecular technologies to further optimize diagnosis and patient care.”

The key innovation in these upgraded products is the automation of specimen preparation using the COBAS AmpliPrep Instrument. The COBAS AmpliPrep Instrument was specifically designed to deliver reliable and consistent specimen preparation for nucleic acid tests. The power of automation for the specimen preparation process yields enhanced operational efficiencies for laboratories that use PCR-based diagnostic tests for the quantification of HIV RNA and the detection of HCV RNA.

Roche Diagnostics had previously received approval for the COBAS AmpliPrep / COBAS AMPLICOR HCV Test, version 2.0, also offering fully automated specimen preparation followed by fully automated amplification and detection of the HCV viral RNA, allowing physicians to assess whether treatment is appropriate.1

The COBAS AmpliPrep / COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 and the COBAS AmpliPrep / COBAS AMPLICOR HCV Test, version 2.0, are in vitro diagnostic, nucleic-acid amplification tests for quantitative detection of HIV-1 RNA and qualitative detection of HCV RNA. Both tests utilize Roche’s proprietary polymerase chain reaction (PCR) technology.

Roche Diagnostics is currently executing plans to launch these upgraded tests in the near future.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, 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 medicines for cancer and transplantation and a market leader in virology. In 2004, the Pharmaceuticals Division generated 21.7 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 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, with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide.

Roche Point of Care Diagnostics, a business area of Roche Diagnostics, supplies products and systems for near patient diagnostic testing in hospitals and outpatient settings.

Roche Diagnostics’ North American headquarters is located in Indianapolis, Ind. (www.roche-diagnostics.us) For further information, please visit our websites www.roche.us and www.roche-diagnostics.com

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