Federal regulators have found problems at one of Theranos' labs, according to The Wall Street Journal's sources. The Silicon Valley startup, famous for its blood tests that require just a finger prick's worth of blood, has been under scrutiny recently due to claims its methods are inaccurate. The WSJ says that the Centers for Medicare and Medicaid Services, which regulates clinical labs, has found "serious" and "severe" deficiencies at the site.
This isn't just more bad PR for Theranos. Although the exact issue has yet to be disclosed, the report claims the inspection results will be publicly released soon, and could put the Northern California lab in question at risk of suspension from the Medicare program.
It's unclear if the problem relates to the "Edison" machines that process the finger-prick blood samples Theranos is famous for. Following FDA probes, only a single blood screen -- for Herpes -- is currently approved for the method. The other hundred-or-so tests the company offers are currently processed using traditional methods, pending the FDA okay. So there's every chance the issue could be misconduct unrelated to the testing methodology that propelled the company to a $9 billion valuation. That said, anything that calls the professionalism of a laboratory into question is not good for Theranos' under-fire business.
We've reached out to Theranos for comment on the WSJ's allegations, and will update this article when we hear back.