|Theranos' Palo Alto, CA, headquarters--Courtesy of Theranos|
Theranos has been shaking things up amid fallout over its proprietary testing technology, making a series of board changes last week and saying that it would publish data validating its tests' accuracy. Next on the company's to-do list is hiring a lab director to oversee one of its key facilities.
As The Wall Street Journal reports, Theranos is looking for someone to run its Newark, CA-based lab as lab experts question the qualifications of its current director. For the past 10 months, Sunil Dhawan, a dermatologist without a degree or board certification in pathology or lab science, has led the facility, which houses proprietary blood analyzers that were created to test tiny blood samples from the company's finger-prick tests. Dhawan technically meets federal and state requirements to run the lab because he's a medical doctor and has experience overseeing a lab affiliated with his dermatology practice.
But to some lab experts, these qualifications don't make the cut. "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 Ph.D. as the laboratory director," Ed Thornborrow, medical director of the clinical labs at the University of California, San Francisco, told the WSJ, adding that Theranos approached him about the lab director job.
The Palo Alto, CA-based company is standing by Dhawan, saying that he "is qualified to be the laboratory director of a high-complexity lab" and that his "training and expertise is highly relevant to the work that he performs for Theranos," the company's general counsel, Heather King, told the WSJ.
Still, the first qualification Theranos has on its website for the Newark lab-director job is "M.D. degree with a Board Certification in Pathology," the WSJ points out. The company has also posted three other senior positions at its Newark lab on its site.
Whoever comes on board to lead the lab will likely have their hands full. Problems with Theranos' Newark lab date back to 2013, when the Centers for Medicare and Medicaid Services stopped by the then Palo Alto, CA-based facility for an inspection. The inspectors found several issues including "unacceptable" results for several blood tests and a lack of documented corrective actions, the WSJ reports.
In 2014, the FDA paid Theranos' Newark site a visit and raised quality issues, saying that quality audits had not been performed at the facility and that Theranos did not lay out an internal quality audit schedule.
|Theranos CEO Elizabeth Holmes|
Meanwhile, Theranos continues to recoup from the fallout over its proprietary testing technology. A few weeks ago the WSJ published articles showing that the company only used its testing device for a small number of its tests by the end of 2014 and that it stopped collecting tiny vials of blood drawn from finger pricks for all but one of its 200 tests after the FDA stopped by for a visit in August and September.
The agency called "nanotainers" developed by the company to collect blood samples an "uncleared medical device" and told Theranos that it needs to get the tools officially approved before use. The news was enough to spook one of the company's partners, Walgreens Boots Alliance ($WBA), which said that it would not open any more Theranos' "wellness centers" at its stores in Arizona and California until the issues are cleared up.
But Theranos CEO Elizabeth Holmes is standing by the company's technology, saying that Theranos decided to limit its finger-prick blood testing in a bid to get FDA approval for its tests. "Right now, just because of this FDA transition, we are only doing one," Holmes said earlier this week. "But that doesn't mean we don't have the technology to do them. There's no reason we can't do peer review and publish other statistics."
- read the WSJ story (sub. req.)
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