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FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
Date:12/2/2009

PLEASANTON, Calif., Dec. 2 /PRNewswire-FirstCall/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food & Drug Administration (FDA) approved an additional intended use for its licensed nucleic acid test, to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas® TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (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 was approved in the US last year for screening plasma specimens from blood donors and, earlier this year, received the CE Mark for screening source plasma.

"Roche is committed to providing the broadest coverage and an easy-to-use menu of screening tests to ensure the highest safety of blood and plasma products," said Daniel O'Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test. "The expanded use of our multiplex test, which has been widely adopted and has demonstrated excellent performance worldwide, is one more step toward that goal. We are pleased to introduce this new use of the cobas® TaqScreen MPX Test in the US as we continue to further invest in solutions for this critical industry."

Human plasma is fractionated into its components, such as immunoglobulins, albumin, and clotting factors, which have many therapeutic uses. These include treatment of chronic and hereditary diseases and disorders such as hemophilia and primary immunodeficiency diseases. Plasma is also used to treat patients who have suffered severe burns or trauma, and during major surgery.

Many countries have implemented Nucleic Acid Technology (NAT) testing in order to further ensure the safety of blood and blood products. In Western Europe and North America, rou
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SOURCE Roche Molecular Systems, Inc.
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