Theranos hired Dave Wurtz and Daniel Guggenheim on July 21 to lead the beleaguered company’s regulatory, quality and compliance departments.
The company’s board of directors also created a compliance and quality committee that will be in charge of regulatory compliance and compliance and quality systems obligations, according to a news release.
Wurtz was named the vice of regulatory and quality, while Guggenheim was named the chief compliance officer. Both men will report to Theranos founder and CEO Elizabeth Holmes.
On July 7, the Centers for Medicare & Medicaid Services (CMS) announced it had prohibited Holmes from owning, operating or directing a laboratory for at least two years. CMS also revoked Theranos’s certification for a blood testing laboratory in Newark, California after discovering problems with the facility during an inspection last fall.
The private company, which Holmes started in 2003, was once valued at $9 billion. Theranos developed a device to collect blood through a finger prick, but the accuracy and reliability of its tests have been questioned.
An article published on March 28 in The Journal of Clinical Investigation found that cholesterol tests were on average 9.3 percent lower when administered at Theranos laboratories compared with tests at Quest Diagnostics and LabCorp, the U.S.’s two largest testing laboratories. Quest Diagnostics and LabCorp collects blood through venipuncture.
In June, Walgreens ended a nearly three-year partnership with Theranos and closed all 40 Theranos blood testing centers in Walgreens’ stores in Arizona.
Wurtz, a former executive with ThermoFisher Scientific, will be responsible for leading Theranos’ regulatory activities, including its relations with the FDA.
Guggenheim, who was assistant general counsel for regulatory issues at McKesson Corp., will oversee Theranos’ compliance program and will make sure the company abides by state and federal regulations.
“Theranos is committed to meeting the highest standards in its compliance practices,” Guggenheim said in a news release. “I am eager to start to build on the foundation that Theranos is making to be a best-in-class health care company.”
Fabrizio Bonanni, MD, who joined Theranos’ board of directors in May, will chair the compliance and quality committee. He is a former executive at Amgen and Baxter International.
“Theranos understands that regulatory compliance is an essential element of any successful and innovative health care company,” Bonanni said in a news release. “This committee will be integral to fulfilling Theranos’ commitment to bringing the highest integrity health information to every person.”