FDA Loves Genetic Tests, If Accurate

By Bio-IT World Staff

June 30, 2014 | In a comment on FDA's blog on Thursday, Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, again restated the Agency's concern with 23andMe's direct-to-consumers genomic tests. The issue,
"at the heart of our five-year effort to work with the firm 23andMe," he says, is accuracy.

Shuren does not say in the blog that the testing 23andMe offers is not accurate, but he pushes back on rhetoric about "empowering the consumer" by arguing that inaccurate tests are never empowering.

"Telling someone they are at high risk for a life-threatening cancer when they are not—or that they are at low risk for diabetes when they actually are at high risk for this chronic disease does not empower consumers. Consumers are not empowered by tests that tell them they need higher or lower doses of widely-used drugs, when the opposite is true," Shuren argued.

A week before Shuren posted his blog, 23andMe announced that the company was filing a 510(k) application to the FDA seeking approval to report results for a single condition, Bloom syndrome. Bloom syndrome is a very rare disease caused by a single recessive mutation, the easiest kind of genetic condition to pin down. The clinical accuracy of a test for Bloom syndrome should be straightforward to show. 23andMe only needs to prove that its process is analytically accurate, showing that its laboratory procedures for analyzing DNA can correctly pick up relevant genetic variants.

If approved, it would be a new step toward progress for the company and the Agency. Read Shuren's blog post.