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FDA Revises Zika Testing Guidelines for Blood Donations

NEW YORK (GenomeWeb) – The US Food and Drug Administration today issued a revised guidance recommending universal testing of donated whole blood and blood components for Zika virus in the US and its territories.

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen whole blood and blood components for the virus, use pathogen-reduction devices, or halt blood collection and obtain whole blood and blood components from areas of the US without active virus transmission.

The revised guidance announced today recommends that all states and US territories screen individual units of donated whole blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products, the agency said.

"There is still much uncertainty regarding the nature and extent of Zika virus transmission," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion."

Hologic and Roche both currently offer molecular blood screening tests that are authorized for use by the FDA under an investigational new drug study protocol. Roche's test, the Cobas Zika assay for the Cobas 6800/8800 systems, received this authorization in March.

Hologic's assay, the Procleix Zika virus blood screening test for the Procleix Panther system, received the same designation in June. Hologic's test is co-marketed with Grifols under a blood safety partnership between the companies, and the Procleix system is currently used by the American Red Cross to test donated blood for HIV and hepatitis B and C viruses.

In a research note, investment bank Piper Jaffray highlighted that the revised guidance could result in a revenue benefit of $13 million to $25 million for Hologic and could add between $.02 and $.05 to annual EPS. Under a national screening program and possible FDA approval of Hologic's assay, the revenue benefit could be about $39 million, the bank noted.

Meanwhile, investment bank Evercore ISI issued a research note suggesting that the total revenue benefit of the revised guidelines to Hologic could be about $15 million, with profitability lower until the FDA approves the test.