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Roche Gets Additional FDA Nod for HIV, Hepatitis Test

NEW YORK (GenomeWeb News) – Roche said today that the US Food and Drug Administration has approved an additional intended use for its licensed nucleic acid test to screen source plasma in pools containing up to 96 individual donations.

The test, called the Cobas TaqScreen MPX, runs on Roche's Cobas s 201 system, and is a qualitative, in vitro test to simultaneously and directly detect different HIV and hepatitis types in human plasma. Specifically, the test can detect HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA, hepatitis C virus RNA, and hepatitis B virus DNA in plasma.

In December, the FDA approved the test in the US for screening plasma specimens from blood donors, and earlier this year the test 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," Daniel O'Day, head of Roche Molecular Diagnostics, said in a statement. "The expanded use of our multiplex test … is one more step toward that goal."

Roche said that the Cobas s 201 system can run multiple channels using multi-dye technology, enabling simultaneous detection of several viruses. Roche is developing another multi-dye assay on the same platform, the Cobas TaqScreen DPX test, which is designed to simultaneously detect B19 virus quantitatively and hepatitis A virus qualitatively, the company said.

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