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Grifols gains CE Mark for Procleix HEV test for detection of Hepatitis E virus RNA.

M2 PHARMA-July 25, 2014-Grifols gains CE Mark for Procleix HEV test for detection of Hepatitis E virus RNA


25 July 2014 - Spanish healthcare company Grifols SA (NASDAQ:GRFS; BME:GRF) said Friday it had received CE mark for its Procleix HEV assay, a qualitative in-vitro nucleic acid amplification test allowing highly sensitive and specific identification of Hepatitis E virus (HEV) RNA in blood donors, blood components, tissues and organs.

The fully-automated test, developed together with US diagnostic and medical imaging products maker Hologic Inc (NASDAQ:HOLX), is intended to identify all four genotypes of HEV. The assay detects HEV RNA in plasma and serum specimens from human donors, tested individually or in pools. The product can also be used to test plasma and serum to screen organ and tissue donors, including cadaveric donors.

The assay is set to be used in Japan, as well as will be commercialised in the European Union to be run on the Procleix Panther system, which provides full automation, simple workflow and a vast test menu in a small footprint. The Procleix Panther system, introduced in 2012, is used by blood banks in over 25 countries, with about 160 instruments placed so far.

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Publication:M2 Pharma
Date:Jul 25, 2014
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