SAN FRANCISCO — With the arrival of consumer-driven health care, more people will have access to their own genome as a way of guiding the management of their physical well-being.
But this has a downside, as 23andMe’s run-in with the FDA last year demonstrates. Misreading the unique markers in the genome might lead to false positives for diseases, or a false negative might prevent a person from getting necessary treatment.
Above: Genentech CEO Ian Clark
Image Credit: Rock Health
Genentech CEO Ian Clark, speaking today at the Rock Health’s Health Innovation Summit, said he understands both sets of concerns.
“I see both sides,” Clark said. “Should consumers have access to the information in their own genome? Definitely. But that information is diagnostic.”
And this is where the FDA gets involved.
Clark points out that reviewing genome-reading services is a new job for the FDA, and it’s one for which the agency hasn’t received any additional funding from Congress.
In the biotech industry, companies have pushed for changes in the law that enables them to pay for regulators to review new products. And “genome companies should be lobbying to do the same thing,” Clark said.
23andMe, by the way, has been working well with the FDA and is now awaiting the regulator’s approval on a new product for a rare but serious inherited condition called Bloom syndrome. As of June 27, the company’s 501(k) application had been received and OK’d for review by the FDA.