FDA Green Lights Roche’s Blood and Plasma Donation Assay

The FDA has approved Roche’s cobas TaqScreen MPX Test, v2.0 for use in the detection and identification of HIV, hepatitis C and B in human blood and plasma donations. This new version has increased sensitivity and is the only test approved to detect and identify these viral targets simultaneously in one assay, Roche said Friday.

The Swiss drugmaker said that the test combines target detection and identification steps and runs on the fully automated cobas 201 system. This eliminates the need for blood and plasma centers to perform consecutive rounds of testing, while also allowing them to alert donors sooner in case of a positive result.

The TaqScreen MPX Test, v2.0 received a CE Mark, as well as Canadian, Brazilian, Chinese and Indian approval, Roche said. — Kellen Owings