FDA Regulators Ease Just a Tiny Bit Their Stranglehold on Direct-to-Consumer Genetic Testing

Testing company 23andMe expresses its gratitude



Anne Wojcicki, the CEO of the genetic testing company 23andMe sent out an email notifying customers that the Food and Drug Administration (FDA) has relented just a little in its obnoxious over-regulation of the company. As the email explained:

Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to offer the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers.

The email added:

The FDA has been incredibly responsive throughout our review and has demonstrated its support for direct-to-consumer genetic testing.

The New York Times further reported:

Anne Wojcicki, the chief executive of 23andMe, said the approval was a first step for her company and the government.

"It shows the F.D.A. is willing and supportive of crafting the direct-to-consumer path," she said in an interview. "It's a very reasonable first step. I would go so far as saying it's a very generous first step."

I don't blame Wojcicki for her obsequious tone. After all, the FDA bureaucrats basically shut down 23andMe in 2013 on the outrageously flimsy rationale that willing customers might be too freaked out by the genetic health risk information supplied by the company. The company was allowed to offer only information concerning genetic ancestry.

How "very generous" of the FDA to allow 23andMe now to offer a single test to which i and several hundreds of thousands of early customers already have our results. In fact, the Bloom syndrome test is just one of 53 trait carrier tests that company offered regular customers as part of it $99 genomic screening test package. As it happens, I carry a recessive variant for only one of the traits: Alpha-1 Antitrypsin Deficiency.

In addition, as an early customer, 23andMe supplies me with genetic information on 122 different health risks and likely responses to 25 therapeutic drugs.

Evidently, FDA regulators are generously thinking about allowing the company to offer more carrier trait tests, but remain decorously silent on the future of direct-to-consumer genetic health risk testing.

To those interested in finding out more about their genetic risks, 23andMe does allow customers to download their uninterpreted genetic data which they can then upload into the Promethease service for a rough-and-ready analysis. To get an idea of what type of analysis Promethease provides, take a look my online genetic information at SNPedia.