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Hologic/Grifols, Roche Molecular Zika Tests Tapped For Blood-Screening Ramp-Up

 
• By Sue Darcey

A blood-screening test made by Hologic in collaboration with Grifols, and another made by Roche Molecular Diagnostics, are being used in a gradual ramp-up of Zika virus screening at blood donation centers across the US under a new FDA program.

Hologic Inc.'s and Grifols SA'sProcleix Zika Virus blood screening assay, and Roche Molecular Diagnostics' cobas Zika Assay on the cobas 6800/8800 systems – operating under US FDA investigational new drug (IND) applications – will be the primary tests used to screen the entire US donated blood supply for the Zika virus over the next 12 weeks, FDA confirmed at an Aug. 26 briefing.

"What I can tell you about use [of these tests] is that FDA has evaluated the information submitted to us, and that we have confidence they will perform appropriately as...

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