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Grifols Babesia Assay Gets IND for Blood Bank Screening

NEW YORK (GenomeWeb) – An assay from Grifols to detect four species of Babesia can now be used under a US Food and Drug Administration Investigational New Drug study for blood screening at selected US blood banks.

The assay runs on the Procleix Panther system and detects B. microti, B. duncani, B. divergens, and B. venatorum parasites that can be transmitted by tick bites or blood donation.

Babesiosis is most common in the Northeast and Midwest. It can be symptomless, but can also lead to hemolytic anemia or complications in people with compromised immune systems.

"The availability of the assay under the IND protocol and in collaboration with the FDA marks another important milestone for Grifols," Carsten Schroeder, the firm's  diagnostic division president, said.

"As leaders in the [nucleic acid technology] blood screening market, we remain committed to preserve the safety of blood donations from the presence of unwanted pathogens. The Procleix Babesia assay will add to our growing portfolio and has been expressly designed to address the needs of the blood banking community."

The firm's Procleix Zika virus assay is also currently being used to test US blood donations under an IND study. Hologic completed the divesture of its stake in Grifols' blood testing business earlier this year.