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Lab Director Sought at Theranos

Lab-testing company Theranos is seeking a new director to oversee its clinical laboratory, the Wall Street Journal reports.

The Journal recently reported on concerns regarding the accuracy of the company's proprietary Edison technology and said the company was running most of its tests using other, standard approaches.

For the past 10 months, the company's clinical lab has been run under the supervision of Sunil Dhawan, a dermatologist, it now adds. While the Journal notes that Dhawan is qualified under state and federal regulations to be a lab director, as he is a medical doctor and has experience overseeing a lab — namely the one associated with his dermatology practice — some lab specialists argue that different skills are needed to gauge whether a tissue specimen shows signs of cancer versus running a full-blown reference lab.

"When you consider the complexities of a reference lab with an expansive test menu, it would be next-to-unheard of to have anything less than a full-time pathologist or laboratory scientist with a PhD as the laboratory director," Ed Thornborrow, the medical director of the clinical labs at the University of California, San Francisco, tells the Journal.

The paper also notes that Theranos' lab facilities were inspected in 2013 by the Centers for Medicare and Medicaid Services, which found a number of deficiencies, though the company says none of them were serious. That inspection pre-dates Dhawan's tenure there.

The FDA inspected the company's lab more recently and though it, too, found some problems, Karen Becker, the managing director of translational and regulatory sciences at Precision for Medicine, has told GenomeWeb's Turna Ray that many of those issues appeared to have been fixed immediately and that none seemed to be systemic quality system problems.

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