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Grifols, Hologic Hepatitis E Assay CE Marked

NEW YORK (GenomeWeb) – Grifols today announced the Procleix HEV assay for detection of hepatitis E has received CE marking.

Developed in collaboration with Hologic, the test uses nucleic acid amplification technology for the fully automated detection of hepatitis E virus RNA in blood, tissue, and organ donors. The Procleix HEV assay detects all four genotypes of the virus in plasma and serum specimens and will be sold for use on the Procleix Panther system in parts of Europe and other geographies that recognize CE marking.

Since being launched in 2012, more than 160 Procleix Panther instruments have been placed, Grifols said. Earlier this year, Grifols was chosen by the Japanese Red Cross as a partner in nucleic acid screening using the system and associated assays.

Procleix NAT products are developed under a partnership between Grifols and Hologic. Gen-Probe collaborated with Novartis on nucleic acid tests for blood screening and Hologic inherited that partnership when it acquired Gen-Probe in 2012. Grifols, in the meantime, acquired Novartis' transfusion diagnostics business last year and assumed Novartis' blood screening partnership with Hologic.