Theranos Withdraws FDA Application for MiniLab Zika Test
Theranos has confirmed it has withdrawn its request for FDA Emergency Use Authorization for its miniLab Zika virus blood test, following an inspection by the agency. Reports state that 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 company sought agency permission to use for Zika testing its Theranos Sample Processing Unit or miniLab, designed to integrate into a single miniature platform the company’s different testing methods, including hematology, immunology, clinical chemistry, immunochemistry, and nucleic acid amplification.
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.”
Theranos publicly unveiled miniLab at the 68th American Association for Clinical Chemistry (AACC) Annual Meeting, “It’s the beginning of the next phase of the company,” CEO Elizabeth Holmes declared.
Theranos is
eager to move beyond problems that culminated last month in sanctions imposed on its Newark, CA, laboratory by the Centers for Medicare & Medicaid Services (CMS). CMS’ sanctions included revoking the lab’s CLIA certificate, and banning Holmes from owning, operating, or directing a lab for at least two years. Theranos has said it will appeal the CMS penalties, adding that it has made substantial progress toward correcting the deficiencies identified by the agency.Theranos has not commented on that account, a spokesman told GEN, though the company has issued a statement by Dave Wurtz, vice president of regulatory, quality and clinical affairs, “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 my mind, this was a positive interaction with the FDA, and I’m grateful for its collaborative approach,” Wurtz added.
An FDA spokeswoman, Tara Goodin, would not comment on the Theranos application, citing the agency’s policy of not confirming or discussing current and pending product applications. The FDA considers information regarding an application that has yet to receive a decision as proprietary and belonging to the manufacturer/sponsor.
The FDA maintains a database of Establishment Inspection Reports and “Form 483” reports notifying company management of objectionable conditions. No information about Theranos and the miniLab application had been posted at deadline.
On Friday, Theranos said it was appealing the government sanctions that have barred Holmes from running a blood-testing lab for two years.
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.
