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Grifols Obtains CE Mark for Multiplex Molecular Arbovirus Screening Test

NEW YORK – Grifols said on Thursday that it has obtained the CE mark for a multiplex molecular screening test to detect arboviruses.

Called the Procleix ArboPlex Assay, the test is intended for use in transfusion medicine to screen blood donations. It detects four mosquito-borne viruses that cause infection in humans — chikungunya, dengue, West Nile, and Zika virus — using an automated nucleic acid amplification system.

Arbovirus infection rates are currently increasing worldwide, in part due to the geographical expansion of mosquito vectors related to climate change.

The Procleix ArboPlex test uses magnetic-based target capture, transcription-mediated amplification, and chemiluminescence for pathogen RNA detection in plasma and serum. The test runs on the Grifols Procleix Panther system.

Hologic divested its share of the blood donation screening business to its partner, Grifols, in 2016 but continued to supply it with Panther instruments. A single-target Procleix assay to screen blood donations for Zika virus was shown in 2018 to be costly and have low yield. 

Barcelona, Spain-based Grifols said the Procleix ArboPlex Assay will be available in all markets accepting the CE mark following completion of any additional registration and notification requirements.