“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, told WSJ.
When CEO Elizabeth Holmes, who was banned from operating a lab for two years after the company was caught selling inaccurate blood tests to consumers, announced the miniLab’s launch at the American Association for Clinical Chemistry (AACC) conference earlier this month (August 1), she claimed that the blood-based test would one day be able to run 160 different assays, from lipid panels to Zika tests. That same day, the company put out a press release stating that it had already tested the device on blood samples collected by finger pricks from patients, including those in the Dominican Republic, and had submitted “validation data for this Zika assay to the FDA for an Emergency Use Authorization.” But according to sources cited by the WSJ, some data in that submission had not followed review-board-approved protocols.
“As with the last phases, Theranos’ implementation of the miniLab may have played too fast and loose with federal regulations,” The Verge reported.
According to WSJ, Theranos investors received an email from the company last Saturday stating that it plans to collect additional data and resubmit an FDA application for emergency clearance of the Zika test, and that it would eventually do the same for an Ebola test.