Certainly, there are legitimate concerns about 23andMe’s approach. Although the accuracy of the technology used is considered to be high, there are no agreed standards to which the company can conform for validating hundreds of simultaneous variant calls. And consumers might not read or fully understand the company’s clear statements that its tests identify only the most common genetic variants and cannot substitute for genetic testing ordered by physicians.
Nonetheless, as scholars who study how individuals respond to their own genetic information, we contend that the FDA’s precautionary approach may pose a greater threat to consumer health than the harms that it seeks to prevent. Data from more than 5,000 participants suggest that consumer genomics does not provoke distress or inappropriate treatment.
Read the full, original story: Regulation: The FDA is overcautious on consumer genomics