Theranos appoints new execs, compliance board


Under-fire diagnostic company Theranos is making moves to tighten its regulatory and compliance efforts.

In response to events over the past few months, the Palo Alto-based company has now appointed two executives to lead its regulatory, quality and compliance departments.

Dave Wurtz, former senior director of regulatory, quality and compliance at Thermo Fisher Scientific, will take up the position of vice president of regulatory and quality, whilst Daniel Guggenheim, former assistant general counsel for regulatory law at McKesson Corp, will take up the reigns as chief compliance officer. Both will report directly to CEO Elizabeth Holmes (pictured).

A newly established Compliance and Quality Committee has also been created by the company’s Board of Directors. The committee will be chaired by Board of Directors member Dr Fabrizio Bonanni.

“Theranos understands that regulatory compliance is an essential element of any successful and innovative health care company,” said Bonanni. “This committee will be integral to fulfilling Theranos’ commitment to bringing the highest integrity health information to every person.”

The move follows a string of bad publicity for Theranos, ranging from an FDA intervention in October last year to Walgreens calling time on its partnership with the company.

The stripping of its Newark, California facility of its certification and its decision to void thousands of tests conducted between 2014 and 2015 compounded the company’s woes.

CEO Elizabeth Holmes was also recently banned from the blood-testing field by US federal regulators for two years which could force the company to completely re-focus its business.

The situation seems almost unrecoverable for a company that was once lauded as one of the most exciting start-ups in the field due to its potentially revolutionary ‘nanotainer’ technology. The platform was intended to completely overhaul blood diagnostics by using dramatically smaller blood samples to diagnose conditions.

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Marco Ricci

25 July, 2016