Dive Brief:
- Embattled blood-testing firm Theranos Inc. will fully refund more than 175,000 Arizonans who purchased a blood test from the Silicon Valley company between 2013 and 2016, paying $4.65 million in a settlement with the Arizona Attorney General announced Tuesday.
- In addition to the consumer restitution, Theranos will pay the Attorney General's office $200,000 in civil penalties along with $25,000 in legal fees. Under the agreement reached, however, Theranos did not admit any wrongdoing and denied charges it misrepresented the accuracy of its technology.
- The deal with the Arizona Attorney General followed a separate settlement with the Centers for Medicare and Medicaid Services (CMS), disclosed Monday, that resolved all regulatory proceedings in return for a commitment Theranos would not own or operate a lab for the next two years.
Dive Insight:
Theranos meteoric rise to the ranks of Silicon Valley unicorns was matched only by its rapid unraveling in the face of accusations of fraud and misrepresentation of its blood-testing tech's accuracy.
Last summer, CMS banned Theranos founder Elizabeth Holmes from the business for two years and yanked the company's operating certificate for a critical California facility after inspections had uncovered serious deficiencies in the company's testing processes.
Theranos had appealed the ban and related sanctions, but announced in October last year that it would close its clinical labs and step away from the retail blood-testing business. The pivot marked a dramatic turnaround for a company which had lured millions in investments on the promise of its finger-prick technology.
The settlements with the Arizona Attorney General and CMS put to rest some of Theranos' legal headaches, but a number of lawsuits and criminal investigations remain unresolved.
Under the deal with CMS, the regulator withdrew the revocation of Theranos' CLIA operating certificate and reduced its monetary penalty to $30,000. As a result, Theranos dropped its appeals of CMS sanctions and agreed not to own or operate any clinical labs within the next two years.
In comparison to that relatively light fine, Theranos will pay more substantially to settle the Arizona Attorney General's charges.
Notably, Theranos will reimburse the full amount paid for each blood test regardless of whether the results were voided or corrected by the company. Roughly 10.5% of the 1.5 million blood tests administered to Arizonans between 2013 and 2016 were voided or corrected, a step Theranos took after coming under fire over its test's accuracy.