Theranos has withdrawn its request for emergency clearance of its blood test for the Zika virus, the Wall Street Journal reports. This, it adds, come as federal regulators found that the company collected data without an institutional review board-approved patient-safety protocol.
The embattled blood-testing firm unveiled its new miniLab system at the American Association for Clinical Chemistry earlier this month. As GenomeWeb reported at the time, CEO Elizabeth Holmes said the company had submitted validation data to the US Food and Drug Administration for a Zika virus assay that runs on the miniLab.
This application prompted the FDA inspection that found that Theranos had collected some data without the proper human subject protections in place, the Journal adds.
"We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency," Dave Wurtz, Theranos's vice president of regulatory, quality, and clinical affairs, tells the Journal. The company further says it plans to collect additional data under the proper protocols and re-submit its application.
Earlier this year, Theranos ran into regulatory issues with the Centers for Medicare & Medicaid Services, which uncovered deficiencies at one of the company's labs and has since issued a number of sanctions against the company, including barring Holmes from owning or operating a clinical lab for two years. Theranos is currently appealing those sanctions, the Journal notes.