Theranos will have to wait until 2019 before it can operate a blood testing lab again.
On Tuesday, Theranos said that it had settled up with Centres for Medicare and Medicaid Services, the government agency responsible for regulating blood-testing labs.
As part of the settlement, Theranos has to pay $US30,000, and the company won’t be able to own or operate a clinical lab within the next two years. In return, the CMS is no longer revoking Theranos’s CLIA certification, which is needed to run a blood-testing lab.
“The Company looks forward to working with regulatory authorities to secure approval for these innovative technologies,” Theranos said in a news release.
In January, The Wall Street Journal reported that Theranos had failed a CMS inspection of its Arizona lab, just a few days before Theranos decided to shut down all of its clinical labs on October 5. A year earlier, Theranos’s Northern California lab also failed a lab inspection.
In October, Theranos pivoted to focus solely on developing its technology instead of simultaneously operating clinical laboratories. The end goal? Getting its miniLab machine (which only requires a small amount of blood to function) in places that have difficulties sending full blood samples to a traditional, full-blown clinical lab operation.
The technology debuted in August as part of Theranos’ attempt to be what Holmes called a “decentralized” lab, meaning the test could be processed without needing to be shipped back to a brick-and-mortar lab.
Theranos’ saga came into the spotlight in October 2015 after The Wall Street Journal published an investigation that questioned the accuracy of Theranos’ blood test.
The company still faces lawsuits from investors, patients, and its once partner Walgreens, which ended its relationship with Theranos in June 2016 and is accusing Theranos of breaching its contract. Theranos has said it will “respond vigorously to Walgreens’ unfounded allegations.”
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