FDA asks Zika test sponsors to request EUAs

FDA is requesting that sponsors of Zika virus tests apply for Emergency Use Authorization (EUA) from the agency. In a statement to BioCentury, the agency said Zika tests "should not be used for clinical diagnosis" without FDA's approval, clearance or authorization.

FDA also requested a meeting with MD Biosciences Inc. (St. Paul, Minn.) and asked the company for more information about its marketed Zika test. The company launched the test last week without premarket clearance, approval or an EUA. At the time, VP of Clinical Diagnostics Susan Belzer told BioCentury the test would not require FDA approval. ...