Roche Diagnostics announces the FDA-approval of the Elecsys® antibody to hepatitis B surface antigen and hepatitis B surface antigen (anti-HBs and HBsAg) assays for use on the MODULAR ANALYTICS E170 Analyzer

Aids laboratories in the diagnosis of HBV disease associated with HBV infection.

Roche Diagnostics is pleased to announce the FDA-approval of the Elecsys antibody to hepatitis B surface antigen (anti-HBs) and hepatitis B surface antigen (HBsAg) assays for use on the MODULAR ANALYTICS E170 Analyzer. With this approval, these assays are now available on both the Elecsys^® 2010 and MODULAR ANALYTICS analyzerplatforms. Anti-HBs has also been approved as a quantitative test on both analyzers.

Electrochemiluminescence (ECL) technology delivers excellent analytical sensitivity and specificity on both tests for the Elecsys 2010 and MODULAR ANALYTICS E170 analyzers. The combination of analytical sensitivity and specificity of the Elecsys Anti-HBs and HBsAg may be used for the laboratory diagnosis of HBV disease associated with HBV infection.

Elecsys Anti-HBs offers an 18 minute turnaround time and a quantitative result on both analyzers. HBsAg also offers an 18 minute turnaround time with a qualitative result. Standardization of the 18 minute tests on the MODULAR ANALYTICS systems improves analyzer efficiency for optimal workflow of 170 tests per hour.

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 totalled 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 websites at www.roche-diagnostics.us and www.roche.com.

ELECYS and MODULAR are trademarks of Roche.

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

For further information please contact:

Doyia Turner
Corporate Communications
Phone: 317-521-7252
e.mail: doyia.turner@roche.com