FDA Grants Approval of Blood Screening Assay for Hepatitis B

The FDA has approved a supplemental application to use Gen-Probe’s Procleix Ultrio assay to screen donated blood for the hepatitis B virus.

The FDA previously had approved the assay to screen donated blood for HIV-1 and the hepatitis C virus. It can now be used to screen donated blood, plasma, organs and tissue for all three viruses in individual blood donations or in pools of up to 16 blood samples.

Based on full approval of the assay on the company’s Tigris system, Gen-Probe said it expects to receive a $10 million milestone payment from Chiron.