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FDA Approves Roche's Cobas Multiplex Test for HIV, Hepatitis Screening in Donated Blood

This article has been updated from a previous version to include further information and comments provided by Roche.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration said yesterday that it has approved Roche’s Cobas TaqScreen MPX Test for screening for the presence of different types of HIV in donated blood plasma and tissue.

The test detects 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 MPX test is approved for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma, FDA said. It is also intended for screening tissue specimens obtained while the donor’s heart is still beating.

Roche launched the automated Cobas s 201 system and the Cobas TaqScreen MPX Test outside the US in 2006.

"We are pleased to introduce it in the US as we continue to further invest in solutions for this critical industry," said Daniel O'Day, head of Roche Molecular Diagnostics.

“With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients,” said Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

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