Beleaguered Theranos has hired a pair of industry executives in an apparent effort to right a ship that has been foundering in light of questions regarding the validity of its blood tests.
The company announced that it has named Dave Wurtz as vice president of regulatory and quality and Daniel Guggenheim as chief compliance officer.
The news comes in the wake of turbulent times for Theranos. The past few months have seen the Centers for Medicare & Medicaid Services levy sanctions that revoked the CLIA certification of its Newark, CA, lab and bar the owners and operators, including CEO Elizabeth Holmes, from operating the facility for at least two years.
That was earlier this month. In June, Walgreens ($WBA) scuttled its relationship with the company when it closed all 40 Theranos Wellness Centers at Walgreens stores in Arizona. The move cost Walgreens about $50 million it had invested in Theranos. However, the hit was harder on the blood-testing outfit as it lost validation of its tech that the partnership provided as well as its primary source of revenue.
Once a Wall Street darling, Theranos began to take on water last fall after the Wall Street Journal published an investigative series on the validity of the company’s blood test results. That’s when regulatory scrutiny began to focus on Theranos.
Now Wurtz, who has nearly two decades experience in U.S. and international regulated industries that include life sciences, and Guggenheim, an attorney versed in health care compliance and regulations, will be calling some of the shots at Theranos.
Both will report directly to Holmes, and their appointments are effective immediately.
"I look forward to leading the execution of the company's FDA submissions strategy to seek further clearance and approval of Theranos' proprietary technologies and support the implementation of rigorous procedures and practices across its operations," Wurtz said in a statement.
“I am eager to start to build on the foundation that Theranos is making to be a best-in-class health care company," Guggenheim added.
Additionally, the company’s board of directors said it created a Compliance and Quality Committee that will oversee and advise the board and executive leadership on regulatory compliance and quality systems obligations. Dr. Fabrizio Bonanni, who joined the board in May, has been named chair of the committee.
- here’s the release
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