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Roche Obtains CE Mark for Cobas DPX Assay

NEW YORK (GenomeWeb) – Roche today announced that its cobas DPX test for parvovirus B19 and hepatitis A virus in human plasma products has received the CE mark.

The cobas DPX assay is a real-time PCR duplex assay for use on the cobas 6800 and 8800 systems that uses nucleic acid amplification testing to detect viruses in blood and plasma products.

The DPX assay enables testing facilities to process blood donations more efficiently while also preserving high safety standards for plasma products used in transfusions, Roche said in a statement. It added that the test complements its current menu of blood donor screening tests, including tests for the detection of HIV, hepatitis C virus, hepatitis B virus, hepatitis E virus, and West Nile virus.

Roche has launched the DPX assay in markets that recognize the CE mark. The test is not available in the US.

Earlier this month, Roche received the CE mark for its hepatitis B viral load test. In January, the firm's cobas TaqScreen MPX Test v2.0 for blood screening received US Food and Drug Administration approval.