FDA approves Roche's nucleic acid test that screens for HIV in donated blood

12/31/2008

ROCKVILLE, Md. The Food and Drug Administration has approved Roche Molecular Systems' Cobas TaqScreen MPX Test. The MPX test is the first nucleic acid test that screens for the presence of two types of HIV in donated blood plasma and tissue, the FDA said.

"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 the donated blood and tissue are free from infection, and providing better protection for patients," FDA Center for Biologics Evaluation and Research director Jesse Goodman said in a statement.

The test detects nucleic acid from HIV-1 Group M, the most common strain of the virus, and hepatitis B and C. It also detects HIV-1 Group O and HIV-2, both of which are most common in Africa, but have shown up in the United States.

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