FDA Greenlights Hologic and Grifols’ Zika Virus Assay

The FDA has approved Hologic and Grifols’ jointly developed Procleix assay for screening donated blood for the Zika virus in the U.S.

For now, the assay will be used in “prominent” U.S. blood centers in southern states, the companies said, but the assay may be extended to other parts of the country depending on the virus’ movement.

The test, which falls under the FDA’s IND study protocol, will run on the Procleix Panther system, a nucleic acid technology-based blood screening platform. — Anisa Jibrell