Blood testing company Theranos Inc has just withdrew its latest request for emergency clearance of a new Zika virus blood test after federal regulators discovered that the company failed to include proper patient safeguards in a recent study of this new test.
Theranos founder Elizabeth Holmes said, on August 1, that this new blood testing device—which she called miniLab—was designed for the specific use outside of traditional clinical laboratory settings and, furthermore, could run accurate tests from only a few drops of blood.
This test, of course, could be monumentally in terms of viral blood testing both in a domestic American capacity and, more importantly, in remote settings. Concurrently, Ms. Holmes had also announced that Theranos had been seeking clearance for its new Zika test; and they even went so far as to collect finger-stick blood samples from patients, including patients in the Dominican Republic, and then run the tests on this new miniLab device.
At the time, it appeared that the tests were working. However, a Food and Drug Administration inspection, conducted earlier this month, found that the company had collected some of its accuracy-supporting data of the Zika test without first following patient-safety protocol previously approved by an institutional review board.
“In my mind, this was a positive interaction with the FDA, and I’m grateful for its collaborative approach,” Dave Wurtz, Theranos’s vice president of regulatory, quality and clinical affairs said in a statement. “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.”
In response to this setback—certainly not the first—Weill Cornell Medicine central lab director Stephen Master said, “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. 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.”
The company now reports that since the time of the sanction announcement, they have made “substantial progress” towards correcting the issues identified by CMS; these issues include: “appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs.”