CLN Article

FDA OKs Parasite Blood Screening Test Under IND Study

Regulatory Roundup: July 2017

Under the investigational new drug (IND) study protocol, the Food and Drug Administration has authorized Grifols’ Procleix Babesia assay to be used in screening blood donations for the four clinically relevant species of the tick-borne parasite Babesia. Whole blood samples from selected blood banks across the U.S. can now be collected and tested with the Procleix assay for the presence of Babesia microti, Babesia duncani, Babesia divergens, and Babesia venatorum. The assay is performed on the Procleix Panther system, a fully automated platform that uses nucleic acid technology to detect pathogens in blood.

Most blood donations in the U.S. are already screened with the Procleix Zika virus assay, which was released in June 2016, also under the IND protocol.