23andMe leaves the Reservation and Goes Clinical.

As I had postulated before, in order to move towards a profitable direction the DTC companies would have to choose "Medically Relevant" or "Novelty Testing" From this recent email sent to me by a reader it is clear, 23andME is Choosing to become a clinical service, without accepting the clinical responsibility.

Hello Patient X,
There's a wealth of new information in your 23andMe account. Our scientists have recently added a number of new articles to our Personal Genome Service, including two that may be of special interest.

If you take cholesterol-lowering statin drugs, be sure to check the new article for Statin Response, which deals with rare but serious side effects that may be influenced by genetics.

And for our members who have the data> from our v2 chip, we've added important information about BRCA1 and BRCA2 -> genes with variants having a quite rare but significant correlation to breast and ovarian cancer - in BRCA Cancer Mutations (Selected).

You can read these or any of our other recently published reports here.

And check out the expanding list of topics being added by your fellow community members here. Please join the conversation!

Best Wishes,
The 23andMe Team

So there you have it! BRCA1 testing on the V2 chip from 23andMe. I never, ever, ever thought that they would lay this stake so quickly. Yes, it is clear. 23andMe wants to report, directly to the consumer BRCA1 genetic test results! It is a variant and it is being reported.

Do they have medical malpractice coverage?
Are they covered by HIPAA?
Do the have the HHS Certificate of Confidentiality?

NO.

Rest assured, I have forwarded this information on to the California Department of Public Health as well as EGAPP. People do deserve to know results of these tests, there is no doubt about that. But people also deserve to have the legal protections afforded to all others who do genetic testing through a provider. These protections include significant regulations mandated of labs as well as ordering providers.......

I said last month that we would know which way these companies will go in 6 months. Looks like it took 23andMe only 1 month.......

The Sherpa Says: Pharmacogenomics and BRCA testing is in the realm of Clinical Medicine my friend.......so shall end your punch line of "Testing for Fun" I look forward to you taking medical responsibility for your actions. I hope you do too.......