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Theranos Closes Its Labs

Theranos is closing its clinical labs and wellness centers, according to an open letter from CEO Elizabeth Holmes. This move will affect some 340 employees. The firm is to instead focus on its new miniLab platform.

Earlier this year, US regulators uncovered deficiencies at Theranos's California lab and proposed sanctions against the firm, including revoking its CLIA certification and barring Holmes from owning or operating a clinical lab for two years. In addition, a series of articles about the firm beginning about a year ago in the Wall Street Journal reported that the company didn't use its own technology, the Edison platform, for its blood tests and raised issues about its proficiency testing. The company later issued tens of thousands of corrected lab results and split from its retail partner, Walgreens. It is also under a federal criminal investigation and a Securities and Exchange Commission probe.

Over the summer, the firm tried to pivot. Holmes announced at the American Association for Clinical Chemistry annual meeting that Theranos was launching a new diagnostic testing tool dubbed miniLab. As GenomeWeb reported, Holmes also said the company had submitted validation data to the US Food and Drug Administration to get an emergency use authorization for a Zika virus assay that runs on the miniLab. The firm has since withdrawn that request.

That the firm was seeking a EUA for a Zika assay just as its Centers for Medicare and Medicaid Services sanctions were to go into effect raised questions about the company's strategy, GenomeWeb's Turna Ray wrote in August. This, she said, raised the possibility that Theranos would instead seek to sell its testing technology and platforms to labs that are CLIA certified. She noted, though, that it would take time for the company to build trust within the lab community.

But that appears to be what Theranos is doing. In the open letter, Holmes says the company will now be turning its full attention to its miniLab platform and its commercialization. "Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care," Holmes writes.