Theranos Withdraws Zika Test Application Following FDA Inspection

As the Zika virus threat accelerates, a number of companies have received U.S. Food and Drug Administration (FDA) Emergency Use Authorization for their rapid Zika diagnostic tests. However, Theranos, the diagnostic startup already plagued by a number of regulatory issues, will not be one of them—the company has voluntarily pulled its request for FDA emergency clearance of its Zika virus blood test.
 
The Zika test was first introduced during the American Association for Clinical Chemistry’s (AACC) annual meeting earlier in August. Blood samples had been collected via fingerstick from several patients, including those in the Dominican Republic, an area where the virus is prevalent. They were shipped to Theranos’ Palo Alto, Calif. lab for processing on the company’s miniLab, a new platform to conduct diagnostic tests outside of the lab with a few drops of blood.
 
According to anonymous sources cited by the Wall Street Journal, during an FDA inspection earlier this month Theranos had collected data to support the test’s accuracy without an institutional review board-approved protocol for patient safety.
 
“It’s unfortunate for Theranos to be caught in another compliance issue so soon after the major issues were reported with their clinical testing laboratory,” Stephen Master, director of the central lab at Weill Cornell Medical College, wrote in an email to The Washington Post. “Given the amount of scrutiny they’re under, I would have expected them to be particularly careful about the regulatory issues surrounding research on human subjects.”
 
“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” said Dave Wurtz, Theranos’s vice president of regulatory, quality, and clinical affairs to the Wall Street Journal. The FDA declined to comment on the inspection.
 
This news follows Theranos’ decision last week to appeal the sanctions that the Centers for Medicare and Medicaid Services (CMS) had placed on the company’s lab in Newark, Calif. “Theranos has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs,” the company stated in a release.
 
Theranos intends to resubmit the Zika test for approval.