The FDA should back off of 23andMe and allow the firm to continue selling its consumer genomics service because it is unlikely to lead to unnecessary diagnostic tests and medical procedures, argues Forbes writer Frida Polli.
Polli takes issue with FDA's recent move to make 23andMe cease marketing its health-related genomics services, saying that the concern that people will go directly from receiving specific genetic information and to rush to expensive and unnecessary tests or procedures is overrated.
"Many steps exist between a woman learning through 23andMe that she has a mutation in one of the BRCA genes linked to breast cancer, and her undergoing a double mastectomy," she writes. "While the 23andMe kit comes in the mail and the results in an email, surgery is hardly undergone with the same ease."
Further, early detection was a main reason for creating the company, Polli says, noting that early detection and prevention may offer savings for the healthcare system.
Polli echoes the sentiments of others, including Misha Angrist, who have argued against FDA's intervention, which some view as overly paternalistic and stifling to new industry.
The big question FDA posed to 23andMe that Polli does not address, however, is whether the test works. If the company is claiming that the genetic information it provides is for use in health, rather than for curiosity or ancestry information, FDA has said it wants to know if the test is valid.