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Theranos hit by another setback as it withdraws request for Zika test approval

Theranos hit by another setback as it withdraws request for Zika test approval


The company collected data without necessary safeguards, reports The Wall Street Journal

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Troubled diagnostic company Theranos suffered another blow as it withdrew its request for federal approval of a new Zika virus blood test, The Wall Street Journal reports. The Food and Drug Administration is said to have turned up evidence that Theranos began testing the diagnostic without the necessary protections for human subjects of research.

The withdrawal is just the latest in a string of setbacks

Over the past year, scandal has dogged the startup that was once valued at $9 billion. In May, the company threw out tens of thousands of results from its Edison blood-testing machine and issued corrected lab test reports to patients. But in an attempt to get back on its feet, the company unveiled its latest miniaturized diagnostic device — called the miniLab — that it says will be able to run several tests on blood samples, including a test for Zika. Theranos had already begun trials on blood samples collected in the Dominican Republic when it announced the miniLab earlier this month.

But now, Theranos has voluntarily withdrawn its request for the FDA’s emergency use authorization that would have sped the Zika test to market, the Journal reports. The company intends to resubmit it after collecting data with the appropriate safety approvals.

The withdrawal is just the latest in a string of setbacks, beginning with a report in The Wall Street Journal that revealed the company was using its inventions for only a fraction of the tests sold to patients. The Verge found that as of December 30th, 2015 the company’s proprietary technology hadn’t been vetted by any federal agencies for more than two years — even though consumers were already using the tests. A partnership with Walgreens crumbled. Theranos became the subject of a federal investigation. And a series of sanctions leveled against the company in July by the Centers for Medicare and Medicaid Services revoked the certification for the company’s Newark lab and prohibited it from conducting patient testing. The sanctions also banned Theranos founder Elizabeth Holmes from operating the labs in the US for two years.

Just last week, the beleaguered company announced that it intends to appeal these sanctions. "Theranos has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs," it wrote in a news release.

Had Theranos been able to (at least partially) vindicate itself with a good, fast, and cheap test for Zika virus, it would have helped rebuild the company’s tattered reputation. But once again, it fell short of federal requirements — putting a damper on the hopes Holmes shared when she announced the miniLab. It was to be the "beginning of the next phase of the company, as we introduce our technologies to the world," she said.

As with the last phases, Theranos’ implementation of the miniLab may have played too fast and loose with federal regulations.