With the threat of Zika looming, several companies have had their Zika diagnostics approved under the FDA’s Emergency Use Authorization. But not Theranos, which pulled its request for emergency clearance of its Zika blood test due to an incorrectly executed study.
Theranos, which has been taking on water since last fall over the validity of its fingerprick blood tests, failed to include “proper patient safeguards” in a study of its Zika test, according to unnamed sources quoted by The Wall Street Journal.
CEO Elizabeth Holmes first introduced the Zika test at the the American Association for Clinical Chemistry’s annual meeting earlier this month. Theranos had collected fingerstick blood samples from subjects, including from patients in the Dominican Republic, to be run on the Theranos Sample Processing Unit, or miniLab, in Palo Alto, the company said. The miniLab is a new platform for performing diagnostic tests outside of a lab. The company had submitted data for FDA Emergency Use Authorization and was “unaware of any currently available capillary test for the Zika virus,” Theranos said at the time.
Since then, FDA inspectors have inspected Theranos in response to its emergency clearance request, the WSJ reported. The regulators determined that Theranos collected this data without using a patient-safety protocol that was approved by an institutional review board, said sources quoted by the WSJ.
“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’ vice president of regulatory, quality and clinical affairs, as quoted by the WSJ. The company intends to collect further data under review board-approved protocols and to resubmit the Zika test for emergency clearance, according to an email to investors seen by the WSJ.
Theranos’ miniLab, for outside-lab use, could be an alternative source of revenue for a company whose owners and operators are barred from owning or operating a lab for two years, per Centers for Medicare and Medicaid sanctions. CMS handed down the sanctions, which included the revocation of the lab’s CLIA certificate, in July based on deficiencies the agency found at Theranos’ Newark, CA lab. Theranos announced last week that it plans to appeal the sanctions.