It's been an interesting week for Theranos. After coming under fire in October for claims made by the Wall Street Journal about the efficacy of its "revolutionary" blood tests, CEO Elizabeth Holmes commented Thursday at the Forbes Healthcare Summit in New York City that the company is on its feet and doing better than ever.
However, emails obtained by The Washington Post and released Wednesday reveal a U.S. Department of Defense official investigating the biotech startup's claims had doubts about their validity and legality going back as far as 2012.
In 2012, those doubts manifested as a formal Food and Drug Administration inquiry about the company's intentions to distribute its blood tests without clearance, according to The Washington Post. At that time, Ms. Holmes requested a stop to the investigation based on a claim that the company did not require FDA approval, as its tests were then under review only for a military-based research project, according to the released emails.
Now that its tests are marketed commercially, the company's contemporary troubles have in part come from use of an unapproved medical device, according to the WSJ. Although a Theranos spokesperson said the company has been committed to FDA regulation since 2010, it didn't begin seeking approval for its blood tests until 2013, according to The Washington Post.
Regardless of the bad press and the loss of a $350 million deal to supply its blood tests to Safeway supermarkets, Theranos is still charging forward and hitting milestones, according to Ms. Holmes.
In the last four weeks we've seen our highest volume in the context of patients who come to us because physicians in Arizona have access to our data and that's who we were focused on briefing," she said at the summit.