Theranos just can’t seem to get anything right these days.
The embattled diagnostics company has withdrawn its request for emergency Food and Drug Administration clearance of a test for the Zika virus after an FDA inspection reportedly found sloppy research practices. The Wall Street Journal reported the news Tuesday evening.
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The newspaper said FDA inspectors “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.” These unnamed sources said Theranos did collect some data following IRB-approved protocols, and one said company executives informed staff of the news last week.
Theranos, of Palo Alto, California, confirmed the withdrawal to the Journal, but didn’t say anything about the FDA inspection. Instead, company officials tried once again to put on a happy face. (Maybe they’ve actually come up with a miracle cure for depression, or perhaps are adopting a Willy Wonka-esque demeanor as a tribute to the recently deceased Gene Wilder?)
“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, vice president of regulatory, quality and clinical affairs for Theranos, was quoted as saying.
It’s been in the Theranos playbook for a while, ever since the Journal blew the lid off the Theranos mystique in October 2015. Most recently, CEO Elizabeth Holmes — who’s under federal criminal investigation — pulled what one attendee called a “bait and switch” at the American Association for Clinical Chemistry’s annual meeting on Aug. 1.
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While meeting-goers had been promised peer-reviewed scientific data on Theranos technology, they instead got a preview of a planned new product that may never see the light of day. Rome is burning and the empress is fiddling.
Meanwhile, there was an unsubstantiated rumor on Twitter late Tuesday that Theranos had agreed to sell its assets to an obscure investment firm. It was based on a supposed retweet from an unnamed private account, so take that with a large grain of salt. But isn’t a sale of some kind inevitable at this point?
Photo: Wikimedia Commons
