FDA approves Roche’s Cobas AmpliScreen Hepatitis B Test to improve safety of cadaveric organ and tissue donations
Roche Diagnostics is now the only company with cadaveric claims for HCV, HIV-1 and HBV nucleic acid tests

Today, Roche Diagnostics announced that the United States Food and Drug Administration (FDA) approved its Cobas AmpliScreen Hepatitis B Test to screen individual cadaveric organ and tissue donations for Hepatitis B (HBV) infection. This expanded claim adds to existing approvals for testing whole blood, blood components, and source plasma from living donors.

Tissues from cadaveric sources, including skin, bone, and ligaments, are used in approximately 1 million medical procedures per year (1). These tissues can transmit the same viral infections as blood, and the products from a single tissue donation may be transplanted to as many as 100 patients(1).

“This is very good news for patients awaiting much-needed transplants, as well as for tissue and organ banks worldwide,” said Heiner Dreismann, Head of Roche Molecular Diagnostics, a business area of Roche Diagnostics. “Roche Diagnostics is committed to further improving the safety of these organ and tissue products. We are proud to be the only company that has both FDA approval and CE Mark certification for cadaveric claims for human immunodeficiency virus (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) nucleic acid tests.”

Roche Diagnostics’ blood and tissue screening tests are based on the company’s patented and highly sensitive polymerase chain reaction technology (PCR), which has become the global standard for fast and reliable replication of minute amounts of genetic material to detectable levels. PCR enables detection of the genetic material of infectious agents directly, making it possible to detect infections earlier in the infection cycle than with immunoassay testing, often before the individual making the donation shows any symptoms of disease.

Currently, most tissue donors are tested using enzyme immunoassays, which detect antibodies to the target virus. Immunoassay tests, in contrast to nucleic acid amplification tests (NAT), detect antigens or antibodies that appear later in the infection cycle. Highly sensitive NAT tests, such as the Cobas AmpliScreen HBV Test, can detect HBV DNA much earlier than current serological assays and can reduce the “window period” of detection, that is, the time between infection and the first detection of antigen or antibody. For HBV, studies have shown reduction of the window period with NAT testing by an average of 14 days.(2) This shortening of the window period enables laboratories to further ensure the safety of the tissues used in a variety of therapies.

“We have been looking forward to the approval of this technology for some time to allow the testing of new tissue donors, as well as those from which tissue is currently being distributed, in order to improve the safety of tissue allografts,” says D. Michael Strong, Ph.D., Executive Vice President of Operations at Puget Sound Blood Center.

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, HBV, and HCV have been approved for use in the US and abroad for screening whole blood, source plasma, living donors, and cadaveric organ and tissue donations. Roche Diagnostics' AmpliNAT Test - the first single-tube assay for detection of HIV-1, HCV and HBV in a single triplex reaction - has been used exclusively by the Japanese Red Cross since 1999 to screen 100% of Japan's blood supply. Roche Diagnostics' TaqScreen West Nile Virus (WNV) Test, the first in North America to fully automate the extraction, amplification, and detection steps, 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 nucleic acid testing for blood screening. Additional information about Roche Diagnostics’ blood screening business is available on the Internet at: http://www.roche-diagnostics.com/press_lounge/blood_screening.html

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

For more information please contact:

(1) Goodman, JL. The Safety and Availability of Blood and Tissues—Progress and Challenges;” N. Engl. J. Med; 351, 8; pp 819.

(2) Bush, M.: “Blood Safety in the New Millennium,” (2001), AABB, Ch.2, p35.