It was hard to miss the recent news that 23andMe, makers of the popular at-home genetic test kit, received FDA approval to screen for genetic risk of colon cancer. For about $200, individuals can mail the company a saliva sample and find out whether they have certain genetic variations that have been linked to cancer or other health conditions. While that might sound like something employer health plan sponsors could get behind, in fact the medical community jury is still waaay out on this. My colleague Dr. Mary Kay O’Neill has written about her reservations with genetic testing in general, and this piece in The New York Times offers a good response to 23andMe specifically. In short:
- 23andMe provides a very limited view of limited data – and the information should probably not be used to make decisions regarding a person’s health care treatment or behaviors.
- 510(k) category FDA approval is not an endorsement. All it means is that the product is materially similar to other approved devices and that it is not particularly dangerous. It doesn’t mean that it works or that it’s actually clinically useful.
- Genes are not your destiny – many other factors are involved in disease manifestation (including cancers) like environmental factors (external and internal), epigenetics and more.
I was recently given a 23andMe kit as a gift. While I couldn’t resist checking my ancestry (no surprises there), I declined my “health gene profile” and my advice for employers would be do the same. Put your money and attention elsewhere for now.