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Roche Cobas Blood Screening Test Gets FDA OK

NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has approved the cobas TaqScreen MPX Test v2.0 for blood screening.

The real-time, multi-dye PCR assay is designed to detect and identify HIV, hepatitis B virus, and hepatitis C virus in donations of human whole blood and blood components including source plasma. It runs on the company's fully automated cobas s 201 system, which uses four separate channels for signal detection, enabling simultaneous monitoring of the three viral targets and an internal control.

This latest version of the TaqScreen MPX test has increased sensitivity and is the only FDA-approved test to simultaneously detect and identify HIV, HBC, and HCV, which eliminates the need for consecutive testing rounds and facilitates earlier donor counseling in the event of a positive result, Roche said.

The assay also has achieved CE marking and regulatory approval in Canada, Brazil, China, and India.