Research & Development
Grifols wins US FDA's approval for Procleix Babesia Assay for screening of the Babesia parasite in donated blood
8 February 2019 -

Diagnostic solutions company Grifols reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the qualitative Procleix Babesia assay for the detection of Babesia infection in human donors, including donors of whole blood and blood components for transfusion.

Babesia is a parasite that can be transmitted to humans by tick bites or through donated blood from Babesia-infected donors and according to the CDC), the highest numbers of Babesia infections occurred in Massachusetts, New York, Connecticut, Rhode Island, New Jersey, Maine, New Hampshire, Wisconsin and Minnesota.

The company's qualitative Procleix Babesia assay is used for the detection of the ribosomal RNA from four Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.

The company added the Procleix Babesia assay runs on the Procleix Panther system, which is a fully automated platform utilizing Nucleic Acid Testing (NAT) for blood screening. The Procleix Panther system automates all aspects of NAT-based blood screening on a single, integrated platform. It eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use. The system has received regulatory approvals in countries around the world, including the US.

In conjunction, the US FDA's approval follows a successful multi-centre clinical trial conducted under an Investigational New Drug (IND) study at the American Red Cross, Creative Testing Solutions and Rhode Island Blood Center, an affiliate of the New York Blood Center Inc, in select areas of the US, concluded the company.

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