Basel, March 2, 2004

FDA approves Roche Diagnostics test for use in screening source plasma and organ donors for HIV-1, the leading cause of AIDS

Roche's COBAS AmpliScreen HIV-1 Test v1.5 is the first FDA-licensed nucleic acid test that producers of plasma-based therapeutics can use in their own laboratories

Roche Diagnostics announced today that the United States Food & Drug Administration (FDA) has approved the company's COBAS AmpliScreen HIV-1 Test v.1.5 for use as a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) in both source plasma and organ donors. The test has already been approved and is in use in the US and other countries for screening whole blood donations. Plasma is a component of whole blood from which many protein-based therapeutic products are derived, including those used to treat shock, hemophilia, immunodeficiency syndromes, burns, and other conditions. This test is the first licensed nucleic acid screening test available for manufacturers of plasma-based therapeutics to use in their own labs.

Roche's test uses the company's patented polymerase chain reaction (PCR) technology, which enables detection of the genetic material of HIV 1 directly, earlier in the infection cycle, often before the person making the donation shows any symptoms of disease. Traditional HIV-1 p24 antigen testing, in contrast, detects a protein associated with HIV-1 that appears in the body later in the infection cycle. Licensed nucleic acid screening (that is, screening based on direct detection of the genetic material of HIV-1) had previously only been available to the US plasma industry as an out-of-house testing service.

"These important approvals underscore our commitment to expanding our already strong presence in the blood products sector and to providing tools that help laboratories optimize the safety of blood-based therapeutics and transplanted organs," said Heino von Prondzynski, Head of Roche Diagnostics and member of the Roche Executive Committee. "We are very pleased to offer the source plasma industry its first licensed option for replacing HIV-1 p24 antigen screening with an in-house nucleic acid test , and are also pleased that we can offer the same highly sensitive test to organ transplant screening laboratories."

Bayer Healthcare's Biological Products Division (Bayer BP) supplied much of the data required for Roche's submission to the FDA. Bayer BP received simultaneous approval from the FDA to perform in-house nucleic acid testing for HIV-1 in plasma donations using Roche's COBAS AmpliScreen HIV-1 Test v1.5 with pools of 96 test samples.

"Nucleic acid testing is the state-of-the-art for pathogen detection," said Douglas C. Lee, Ph.D., Director of Nucleic Acid Technologies at Bayer Biological Products. "As a result of this approval, we will be able to directly oversee the screening of plasma samples in our laboratories prior to the manufacturing process."

About Roche Diagnostics' Blood Screening Business

Roche's PCR-based tests are used to screen more units of blood worldwide than any other tests. Roche's COBAS AmpliScreen™ tests for detection of HIV-1 and Hepatitis C (HCV) in donated blood have been approved for use in the US and abroad. The COBAS AmpliScreen HIV-1 Test v1.5 is now also approved in the US for use in screening source plasma and potential organ donors. The COBAS AmpliScreen Hepatitis B Test is approved for use in the EU and is currently in clinical trials in the United States. COBAS AmpliScreen tests are also used in other countries where product registration is not required. Roche's AmpliNAT multiplex system - the first to test for HIV-1, Hepatitis B, or Hepatitis C in a single triplex reaction - has been used exclusively by the Japanese Red Cross since 1999 to screen Japan's entire blood supply. Roche's TaqScreen West Nile Virus Test, the first in North America to highly automate the extraction, amplification, and detection steps, is currently in clinical trials in the US and Canada.

About Roche and Roche Diagnostics

Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of 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 employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division, the world leader in in-vitro diagnostics 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. For further information, please visit our websites www.roche.com and www.roche-diagnostics.com.

About Bayer Health Products Division

Bayer Healthcare AG combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagostics, and Pharmaceuticals, with more than 34,000 people employed worldwide. Bayer Healthcare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. For more information, please visit Bayer Biological Products website at www.bayerbiologicals.com.

For more information please contact:

Melinda Baker
Roche Molecular Diagnostics
Phone +1 (925) 730-8379