Theranos is withdrawing its bid for FDA approval of a diagnostic test for Zika that they announced earlier in August, according to a story in The Wall Street Journal.
Theranos confirmed to Business Insider that the test has been withdrawn, but said the company has plans to resubmit it.
John Carreyrou and Christopher Weaver report that an FDA inspection found that, as part of a study to validate the new test, the company had collected some data without a patient safety plan in place that was approved by an institutional review board.
The role of the board is to make sure that ahead of the trial and during it, the subjects’ rights and welfare are protected, according to the FDA. It’s a standard part of running studies that involve humans.
In the case of the Theranos study, the Journal noted, “it isn’t clear if the problem affected any patients.”
“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency. We are confident in the Zika tests and will resubmit it,” Theranos vice president of regulatory and quality Dave Wurtz said in a statement emailed to Business Insider. Wurtz joined the company in July.
Earlier this month, Theranos debuted a new blood-testing system at the American Association for Clinical Chemistry’s annual conference – its first medical conference appearance – that included a machine that takes the sample of blood and processes it so it can give a diagnosis or tell you your cholesterol level. Theranos is calling the device the “miniLab.”
Along with the miniLab, CEO Elizabeth Holmes also ran through a diagnostic test for the Zika virus, which the company was running studies on in the Dominican Republic and Colombia. As part of that, the company was collecting finger-stick blood samples from the Dominican Republic to validate the test.
The sanctions from Centers for Medicare and Medicaid Services, which has oversight of labs like Theranos’, came after the company failed its California lab inspection. The California lab doesn’t currently test patients, but the company’s Arizona lab is still up and running.
The sanctions from July also included revoking the California lab’s Clinical Laboratory Improvement Amendments license (the regulatory standards that apply to all clinical labs) after 60 days, prohibiting the lab from participating in the Medicare program and canceling the lab’s approval to receive Medicare payments.
“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 said in a release.