Zika Assay Reviews Are Testing The Limits Of FDA Capacity, Shuren Says

12 Sep 2016

• By Sue Darcey

As Congress squabbles over a federal funding bill to fight the virus, FDA reviewers are taking on extra duties and working overtime to approve Zika diagnostics quickly, device chief Jeff Shuren says. The most recent emergency-use authorization targeting Zika extended the usability of a Hologic assay to more patients.

FDA device center director Jeff Shuren says the push to make more diagnostic technologies available to counteract the growing threat from the Zika virus is bringing his review staff to the edge of its capacity.

Ten emergency-use authorizations for Zika assays are listed on FDA's website since March. And, most recently, on Sept. 7 the...