At-home genetic testing is about to get a little more difficult if the Food and Drug Administration has its way. The FDA issued a warning letter this week to the company 23andMe, a genetic test maker, to stop sales of its DNA testing kits consumers can order through the mail.
23andMe says its product can tell consumers if they’re at risk for more than 250 diseases and health conditions. For instance, the company says its kits are able to identify the BRCA gene mutation in women that significantly increases the risk of breast and ovarian cancer.
The company has been around for more than five years, but the FDA says 23andMe has failed to prove its testing kits to be safe or effective, even after numerous meetings and letters back and forth with the company.
In the warning letter, the FDA said it’s concerned about the public safety risk of inaccurate tests that could lead consumers to seek out unnecessary medical care and procedures.
23andMe has 15 days to respond to the FDA letter.
Should the FDA have halted the sale of 23andMe’s testing kits or is the move an act of unnecessary regulation? Have you ever used one of these kits? Did you find it to be accurate or helpful?
Dr. Maren Scheuner, a clinical geneticist and associate professor at the David Geffen School of Medicine at UCLA
Nita Farahany, a bioethicist and professor of genome sciences and policy at Duke University
Arthur Caplan, professor of Medical Ethics at New York University Langone Medical Center