- In response to ongoing regulatory blowback, Theranos—the once high-flying diagnostic company that promised less invasive blood-testing—announced Thursday it had added two high-profile compliance executives to its staff in addition to a new board-level compliance and quality committee.
- Dave Wurtz will become vice president for regulatory and quality, supervising all regulatory and clinical affairs along with new product approvals. Wurtz was previously senior director of regulatory, quality and compliance at Thermo Fisher Scientific.
- David Guggenheim assumes the role of chief compliance officer, set to oversee the company's compliance program. Guggenheim comes to Theranos from McKesson Corp. where he was assistant general counsel for regulatory law.
Theranos used to be a media darling with a reported $9 billion market value, run by wunderkind CEO Elizabeth Holmes. But when the Wall Street Journal broke a story highlighting reported inaccuracies with Theranos’ vaunted finger-prick technology, the facade began to crumble.
Federal regulators recently banned Holmes from the business for two years, while stripping the company's Newark, CA lab of its certification and imposing civil fines. While Holmes can appeal the ban, the sanctions could force Theranos to change its business if they take effect as planned September 5.
From failure to meet quality-control checks to voiding and revising lab results in order to avoid federal penalties, Theranos ran afoul of industry and federal regulations despite recent efforts to remake the company's image and compliance focus.
Whereas Theranos' board of directors was previously full of high-profile luminaries such as former secretary of state Henry Kissinger, the company has restructured its corporate governance, recently adding three new members, including a former top Amgen executive.
The changes expanded Theranos' efforts to bulk up its leadership with members of the scientific and medical communities, which the company had been criticized for lacking. Hiring Wurtz and Guggenheim continues that trend, although it may be too late.
“Theranos understands that regulatory compliance is an essential element of any successful and innovative health care company,” said Fabrizio Bonnani, a Theranos director and chair of the new compliance committee. “This committee will be integral to fulfilling Theranos’ commitment to bringing the highest integrity health information to every person.”