Roche Diagnostics Submits West Nile Virus Blood Screening Test to FDA

Automated test uses real-time PCR to detect West Nile Virus in donated blood & plasma

Roche Diagnostics announced today that it has submitted its Biological License application for the cobas TaqScreen WNV Test to United States Food & Drug Administration (FDA. The test is designed to detect West Nile Virus in donated blood and plasma. The agency will review the application to determine whether the test can be marketed in the U.S.

West Nile Virus is transmitted to humans most often through mosquito bites, but can also be transmitted by transfusion of infected blood or blood products. Most people infected with West Nile Virus never show signs of illness, or recover completely after experiencing several days of flu-like symptoms, but others (especially those with compromised immune systems) can suffer serious and in some cases life threatening reactions.

“We are very pleased to have worked closely with 14 U.S. clinical trial sites, which screen blood from a network of more than 100 donation centers, to address this important public health concern,” said Daniel O’Day, Head of Roche Molecular Diagnostics, the business area of Roche Diagnostics which developed the test. “Their clinical expertise and personal dedication to ensuring a safe blood supply in a highly time-sensitive environment has contributed to development of a test that can help blood centers across the U.S. prevent further transmission of this potentially deadly virus.”

The cobas TaqScreen WNV Test uses Roche’s highly sensitive polymerase chain reaction technology (PCR), the world’s leading nucleic acid amplification technology, to detect the genetic material of the West Nile virus in blood donated by people who may show no symptoms of disease. The United States Centers for Disease Control (CDC) has stated that screening donated blood for West Nile Virus by nucleic acid amplification tests has markedly reduced the risk of transfusion transmission. According to the CDC, blood screening centers across the United States identified 340 donors whose blood tested positive for West Nile Virus in 2006.

The test is designed to run on the cobas s 201 system, Roche’s flexible, modular instrument platform which automates each step of the real-time PCR blood screening process. The system also offers configuration options for fully automated “sample in, results out” processing that require no manual intervention between steps.

Roche initiated clinical trials for its West Nile Virus test in June 2003 to address concerns expressed by the US Food and Drug Administration and Centers for Disease Control and Prevention (CDC) in 2002 about the potential for an increase in transfusion-related West Nile Virus infections during the 2003 mosquito season.

About Roche Diagnostics Blood Screening
Roche Diagnostics is the leading provider of PCR-based nucleic acid tests for the international blood bank market. Nucleic acid-based tests enable more highly sensitive detection of active HIV, Hepatitis C, and Hepatitis B infections than conventional antibody or antigen assays. Roche’s PCR-based COBAS® AmpliScreen tests, which include individual assays for detecting HIV-1, Hepatitis C virus, and Hepatitis B virus in donated blood, have been approved for use in the US, Europe, and other countries. The company’s AmpliNAT test has been used by the Japanese Red Cross since 1999 to screen Japan’s entire blood supply. In 2006, Roche launched the automated cobas s 201 system and the 5-parameter multiplex cobas TaqScreen MPX Test in Europe, designed for single-assay detection of HIV-1 groups M & O, HIV-2, and Hepatitis B and C in donated blood and plasma. (Clinical studies for the multiplex test, performed under an Investigational New Drug Application to the FDA, have been completed.)

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 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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 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 website www.roche.com

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For further information please contact:
Melinda Baker
Molecular Diagnostics Communication
Phone: +1 925-730-8379