While mystery behind their lab practices occupies most Theranos headlines now, there was a “second hit” that scuttled the would-be-unicorn: they bypassed the physician. Theranos’s blood tests offered more information than the average consumer product could provide. Such tests that influence the health of the patient face the harshest scrutiny by the FDA, even with a physician. Remove that doctor and you’ve painted a bullseye on your back. Not convinced?
This isn’t the first Silicon Valley rocket to get knocked out of the sky by the FDA – just ask 23andMe. 23andMe attempted to provide genetic information, specifically health risks, to its consumers without coordinating with a provider. They were ordered to stop in 2013 by the FDA and were required to validate their testing methods. It took two years for the company to resume with FDA approval. They returned with a new test that reported significantly less information. In fact, 23andMe can only report carrier status and does not have approval to report on actual health risks.
While Theranos finds itself in a similar fight, 23andMe chose to cooperate, pivot, and work within the system to bring an approved product to market. If Theranos’s statements are any indication, they seem more inclined to go down with the ship.
Theranos’s story highlights a major difference in innovation in healthcare versus other industries. In health tech, openness and collaboration are a must. Best said by a cofounder of 23andMe to Tech insider, "You have to be willing to show what you're doing," said Linda Avey. "The proof is in the data."