A major health startup cofounder has a message for Theranos: 'Show the data'

SAN FRANCISCO — Linda Avey, cofounder of personal genomics company 23andMe, recently took the stage at Fusion’s Real Future Fair to talk about the future of the biotech industry.

After the panel, Tech Insider asked Avey if she had any advice for Theranos — a blood analysis startup valued at $US10 billion — on how it could rebound from a highly public snafu over its secret technology, just as 23andMe once did.

“Show the data,” said Avey, CEO and cofounder of the personal health tracking startup Curious. “Put the data out there. Be transparent. There’s no getting around that in the industry.”

Theranos promised to change medicine by simplifying blood tests and equipping patients with easy, almost real-time access to their results. But the company came under fire last month following an investigative report by The Wall Street Journal.

Instead of using its much-touted yet secret blood-testing technologies, according to the Journal, Theranos used traditional machines for roughly 90% of customer tests in 2014. The US Food and Drug Administration (FDA) has since stepped in to scale back the use of Theranos’ proprietary technologies.

Many have called on Theranos to release data on how its ground-breaking blood analysis works. CEO Elizabeth Holmes announced in late October — in a reversal of her previous stance — that the company would subject itself to peer review.

The scenario is more than a little familiar to the cofounders of 23andMe, which includes CEO Anne Wojcicki. In 2013, the FDA sent the company a strongly worded warning letter, effectively shutting down the health-related aspects of its popular DNA reports.

An FDA deputy commissioner wrote at the time, “We still do not have any assurance that the firm has analytically or clinically validated the [Personal Genome Service] for its intended uses.”

Yet 23andMe made a comeback in October 2015 by unveiling a new testing experience, although one that’s significantly more regulated and limited.

23andMe’s new DNA report offers 60 pieces of information, including details about a customer’s carrier status for certain diseases, a profile of some hereditary traits, and some information about dozens of non-life-threatening health conditions like lactose intolerance. It also dials back on genetic risk assessments for complex, serious diseases like breast cancer and diabetes.

Avey departed 23andMe in 2009, well before the company ran into trouble with the FDA. Still, it’s not difficult to imagine the scenario facing Theranos for a biotech-industry veteran.

“You have to be willing to show what you’re doing,” Avey tells Tech Insider. “The proof is in the data.”

When asked for comment, Theranos referred Tech Insider to an interview Holmes gave Fortune last week:

“We have not put into the public domain much of our technology and operations, historically,” Holmes said on stage at the Fortune Global Forum. “But there is no reason we can’t do peer-review, and there is no reason we can’t publish other stats and we’re going to do that,” she later added.

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