FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C

Wednesday, December 31, 2008 General News
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PLEASANTON, Calif., Dec. 31 The United States Food & DrugAdministration (FDA) today approved a new nucleic acid test from Roche toscreen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis BDNA in a single, automated assay. The test, called the cobas TaqScreen MPXTest for use on the cobas s 201 system, is a qualitative in vitro test forcomprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA,HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma.The test, which is not intended for use as an aid in diagnosis, is designed tofurther increase the safety of blood supplies by identifying infectionsearlier than traditional serology tests.

"Roche is committed to meeting the needs of blood centers with tests andsystems that ensure the highest blood safety," said Daniel O'Day, head ofRoche Molecular Diagnostics, the business area of Roche Diagnostics thatdeveloped the test. "Our multiplex test has been widely adopted and hasdemonstrated excellent performance in blood centers worldwide. We are pleasedto introduce it in the U.S. as we continue to further invest in solutions forthis critical industry."

The test runs on the fully automated, real-time PCR cobas s 201 system,designed to increase processing efficiency with a unique modular design andready to use reagents.

"The Roche MPX test raises the blood industry to a higher level withregard to overall blood safety, process simplification and process control,"said Louis M. Katz MD, Executive VP, Medical Affairs at Mississippi ValleyRegional Blood Center, one of the TaqScreen MPX clinical trials sites. "Ourorganization looks forward to using the MPX test."

Countries that have implemented NAT testing have demonstrated a reductionin transfusion-related HIV, HBV, and HCV infections. In the U.S. alone, theCenters for Disease Control and Prevention estimates that there are more thanone million people in the U.S. living with HIV/AIDS, with an additional 40,000people being infected each year. It is estimated that 300,000 infected personsare unaware of their HIV status. More than 4 million people in the U.S. havebeen infected with HCV, 3.2 million of whom are chronically infected. HCV isthe leading cause of liver cancer in the U.S. More than 1,200,000 people arechronically infected with HBV and about 5,000 people die of complications ofHBV every year in the U.S. Many individuals with HBV and HCV show no symptomsof disease, and do not know that they are infected.

About Roche Blood Screening

Roche Diagnostics is the leading provider of real-time PCR-based nucleicacid tests for the international blood bank market. Nucleic acid-based tests

enable earlier detection of active HIV, Hepatitis C, and Hepatitis Binfections than conventional antibody or antigen assays. Roche assays havebeen used by the Japanese Red Cross since 1999 to screen Japan's entire bloodsupply. Roche launched the automated cobas s 201 system and the cobasTaqScreen MPX Test outside the United States in 2006 for the mostcomprehensive single-assay detection of HIV-1 Groups M & O, HIV-2, andhepatitis B and C in donated blood and plasma. The West Nile Virus test forthis platform was launched in the U.S. in 2007.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As the world's biggest biotech company and an innovator ofproducts and services for the early detection, prevention, diagnosis andtreatment of diseases, the Group contributes on a broad range of fronts toimproving people's health and quality of life. Roche is the world leader in invitro diagnostics and drugs for cancer and transplantation, and is a marketleader in virology. It is also active in other major therapeutic areas such asautoimmune diseases, inflammatory and metabolic disorders and diseases of thecentral nervous system. In 2007 sales by the Pharmaceuticals Division totaled36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3billion francs. Roche has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech and Chugai, andinvested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Groupemploys about 79,000 people. Additional information is available on theInternet at http://www.roche.com.

All trademarks used or mentioned in this release are legally protected bylaw.For further information please contact: Melinda Baker Roche Molecular Diagnostics Communications Phone: 925-730-8379 Cell: 925-548-1897 email: melinda.baker@roche.com Jessica Brillant Roche Molecular Diagnostics Communications Phone: 925-730-8503 Cell: 925-980-0260 email: jessica.brillant@roche.com


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