Theranos settlement means it could have a lab again in 2019

Theranos has been headed toward disaster for a while through its dodgy blood testing methods, but it might have just avoided the worst possible outcome. The biotech outfit has reached a settlement with the Centers for Medicare & Medicaid Services that should end the legal and regulatory fights between the two. In return for dropping appeals of both its 2-year lab ban and sanctions on its Newark lab, Theranos will both get to keep its all-important Clinical Laboratory Improvement Amendments (CLIA) certificates and reduce its civil financial penalty to $30,000.

This doesn’t put Theranos completely in the clear. It still has to worry about FDA investigations, for a start. And even if it can put all its regulatory troubles behind it, there’s still the matter of regaining the shaken confidence of investors and would-be customers. That’s much, much harder. Nonetheless, Theranos is likely happy to at least keep its CLIA certificates. Without those, it couldn’t legally perform any testing on humans — it would be virtually impossible to pursue the company’s main business, even though it would be clear to open labs by 2019.

Source: Theranos