Vishal Gulati

FDA Opens Door For 23andMe To Market Some Direct-To-Consumer Genome Tests

October 8, 2015

FDA has now released its full advice to 23&Me about direct to consumer genetic testing and on the whole it is good news. It is good because having some guidance is better than no guidance (which had left the whole industry in a bit of a limbo) and also because the advice is something the industry can work with.

In short, in 2013 the FDA stopped the company from marketing its iconic direct to consumer gene testing services without regulatory approvals. In response, the company filed a test case to ask FDA to let them market a test for Bloom Syndrome (a rare error of DNA repair which predisposes people to cancer) directly to consumers. FDA has now approved the application (they have set out conditions about how the company provides information to consumers).

The key positive of this development is that it seems that this guidance for Bloom Syndrome sets the standard for what you need to do to advise customers about autosomal recessive traits. This covers a large number of conditions but excludes many common conditions that are multifactorial eg parkinsons etc which the company is not allowed to communicate to their patients.