Elizabeth Holmes is the CEO of Theranos, a lab company dedicated to quickly processing a full range of laboratory tests from a few drops of blood, rather than numerous tubes, and at unprecedented low costs.
The technology is directly accessible to people and their physicians through Theranos Wellness Centers. Holmes has been an outspoken proponent of making lab tests affordable and accessible to patients.
Theranos recently came under fire from articles in the Wall Street Journal. Last week, in Laguna Beach, Calif., the Journal held its live event, with Holmes speaking to global technology editor Jonathan Krim to set the record straight. You can watch the entire interview through AACentral.com.
During the event, Holmes told Krim that the Journal misrepresented the company’s plans to switch from a CLIA framework to an FDA framework, as well as mischaracterized the FDA’s QSR inspection as evidence that the company’s testing platform was under question by the agency. The assumptions made by the news outlet, she said, are untrue. The FDA today released its report on the inspections, flagging quality issues at a manufacturing plant in Newark, Calif., after inspections in August and September.
The event demonstrates how difficult it can be to educate media about diagnostic testing, not to mention FDA processes. I laughed out loud when the interviewer asked pointedly about the FDA’s “surprise” inspection, as though a surprise quality review from the agency is unusual. In fact, FDA’s QSR inspections are almost always conducted without forewarning, to the point at which there are educational classes on how to be ready, even when you’re not ready.
Throughout the conversation, Holmes was brilliant. She was calm, and clear about Theranos’s product platform, its ethos as a company, and its dedication to providing accurate data.
In addition, Theranos has published a rebuttal to the original Journal articles, saying that it believes the future of clinical labs should be in the hands of the FDA.
“We believe the model for the lab of the future is to take all tests through FDA review,” Theranos said.
