It’s been almost a month since we last heard from beleaguered blood-testing startup Theranos, which means the company has been about due for an embarrassing public fuck-up. Tuesday evening, that fuck-up finally arrived as news came out that the company had botched an application for emergency approval of a new Zika test.
Earlier this month, Theranos CEO Elizabeth Holmes announced that the company was seeking FDA approval of a blood test for the Zika virus using its new miniLab device. According to The Wall Street Journal, however, Theranos withdrew the application after federal regulators raised concerns over improper patient safeguards:
[D]uring an inspection by the Food and Drug Administration earlier this month, regulators concluded that Theranos had collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board, according to the people familiar with the matter. Institutional review boards ensure that patients are treated safely and ethically during medical studies.
It isn’t clear if the problem affected any patients. Some data in the submission was collected under review-board-approved protocols, the people said. Theranos didn’t contest the agency’s findings and withdrew its submission for authorization of the new Zika test, according to people familiar with the matter.
After the Centers for Medicare and Medicaid Services voided two years of data connected to Theranos’ allegedly inaccurate Edison machines, the company introduced the miniLab, which, if sold to other companies, would circumvent Holmes’ two-year ban from operating a lab.
On Saturday, Theranos reportedly told investors the company plans to reapply for federal approval of its Zika test with additional data and also submit an application for an Ebola test “in the same manner.”
“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” a Theranos representative told the Journal.