Therapy Areas: AIDS & HIV
Grifols wins new US FDA approval for the Procleix Ultrio Elite and Procleix WNV assays
20 June 2018 -

Plasma medicine company Grifols (MCE:GRF) MCE:GRF.P) (NASDAQ:GRFS) disclosed on Tuesday the receipt of approval from the US Food & Drug Administration (FDA) for two blood screening assays including Procleix Ultrio Elite and Procleix WNV, with market launch later this year in the US.

The company said Procleix Ultrio Elite is an assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV) as well as detecting HIV type 2 (HIV-2). The assay can be used to test pools of plasma composed of up to 96 individual donations from donors of source plasma.

In addition, the Procleix WNV assay is a highly sensitive, qualitative in vitro nucleic acid assay for the detection of West Nile virus RNA in plasma and serum of human blood donors, according to the company.

Both assays will run on the fully automated sample-to-result NAT blood screening platform Procleix Panther system. The device is an integrated nucleic acid testing system that fully automates all necessary steps from sample processing through amplification, detection and data reduction, said the company.

Grifols added that the Procleix Panther system was launched in Europe in 2012 following the CE mark. In June 2016, the US FDA allowed blood centres the use of Grifols Procleix Zika virus assay with the Procleix Panther system, under an Investigational New Drug study protocol, to screen donated blood nationwide.

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