FDA approves Roche's Cobas AmpliScreen Hepatitis B Test for use in screening Blood Donors
Test is first nucleic acid Hepatitis B blood screening test approved by FDA

Today, Roche Diagnostics announced that the United States Food and Drug Administration (FDA) approved the COBAS AmpliScreen HBV Test for use in a mini-pool format as a screening test for the detection of Hepatitis B (HBV) in donated whole blood, blood components, source plasma and other living donors. The test is the first nucleic acid test designed for screening whole blood for HBV to be approved by the FDA.

The approval follows a decisive vote in favour of licensure at an earlier Blood Products Advisory Committee of the FDA in 2004, at which time Roche Diagnostics presented results from their related five-center clinical study. Roche Diagnostics submitted a Biologics License Application (BLA) to the FDA, for the COBAS AmpliScreen HBV Test to screen plasma samples from donors of whole blood and blood components, source plasma and other living donor organ components.

"This is an important day for the blood screening community and concludes a successful effort by Roche Diagnostics, the blood centers and FDA to bring this important test to market" said Heino von Prondzynski, CEO Division Roche Diagnostics and Member of the Executive Committee. "Implementation of the COBAS AmpliScreen HBV test based on PCR (polymerase chain reaction) ensures that a highly sensitive and robust technology is being used to keep our precious blood supply safe."

In the clinical study, the COBAS AmpliScreen HBV identified two HBV "window cases" (cases within the time between infection and detection of infection by antigen tests) which may have gone undetected by currently licensed HBsAg tests. In these tests, conducted at five blood centers in the US, Roche Diagnostics evaluated 581,790 individual donations in pools of 24. In addition, Roche Diagnostics presented non-clinical study data illustrating that the COBAS AmpliScreen HBV Test reduced the window period by an average of 17 days in 40 seroconversion panels when compared to the currently implemented Hepatitis B surface antigen test. Following the conclusion of the clinical study period, three of the five centers voluntarily chose to continue using Roche Diagnostics' test under a cost-recovery IND (Investigational New Drug) protocol.

Since conclusion of the clinical trial period in 2004, three additional "window cases" out of an additional one million donated blood units were identified using the COBAS AmpliScreen HBV Test.

"Memorial Blood Centers is proud to have been one of the first three centers to use the Roche Hepatitis B blood screening nucleic acid testing assay," said Jed Gorlin, M.D., Vice President of Medical and Quality Affairs, Memorial Blood Centers, Minneapolis. "The study clearly documented the necessity to be vigilant in continuing to screen the blood supply for Hepatitis B. The current Hepatitis B surface antigen assays are very sensitive, but on rare occasions, may still miss small, but potentially infectious amounts of Hepatitis B."

About Roche Diagnostics' Blood Screening Business
Roche Diagnostics' PCR-based tests are used to screen more units of blood worldwide than any other nucleic acid tests. Roche Diagnostics' COBAS AmpliScreen Tests for the detection of HIV-1 and Hepatitis C have been approved for use in the US and abroad for screening whole blood, source plasma, and potential organ donors. The COBAS AmpliScreen HBV Test is approved for use in the EU and is currently the only HBV nucleic acid test to have been approved by the FDA. The COBAS AmpliScreen Tests are also used in other countries. Roche's AMPLINAT multiplex assay - the first single-tube assay to test for HIV-1, Hepatitis C, and Hepatitis B in a single triplex reaction - has been used exclusively by the Japanese Red Cross (JRC) since 1999 to screen 100% of Japan's blood supply. In 2004, the JRC renewed their agreement with Roche Diagnostics for a four year period. Roche Diagnostics' TaqScreen West Nile Virus Test, the first in North America to fully automate the extraction, amplification, and detection steps of PCR, is currently in clinical trials in the US and Canada. Roche Diagnostics is also actively engaged in developing next-generation instrument systems and assays to further integrate and automate the blood screening process.

About Roche
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 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 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, 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.

For further information, please visit our websites www.roche.com and www.roche-diagnostics.com

For more information contact:
Lori LeRoy
Roche Diagnostics
+1-317-521-7159
lori.leroy@roche.com
www.roche-diagnostics.us