23andMe Provides An Update Regarding FDA’s Review | Hacker News Reader

23andMe Provides An Update Regarding FDA’s Review

admin.blog.23andme.com

11 pointsjunofan11 comments

As we work with the FDA to get clearance, there will be some significant changes to the site. Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.

This paragraph is by far the most disappointing with regards to the short-medium term future of 23andMe.

"23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review 23andMe_Logo_blogprocesses."

And that means 23andMe can't follow its business model of crowd-sourcing lots of personal genomic and medical history data to number-crunch its way into having actual information to offer consumers years after they have paid to send their DNA to 23andMe.[1] That plan looked clever to some investors just a while ago, but now investors are finding out that 23andMe is clueless at the top, and trying to make its way in a heavily regulated industry for which the regulator is not about to cave in to cute marketing campaigns.

After it announces its service changes, the company lets us know, "This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team."

A funny detail is that the blog post on the company blog itself has an ad linking to signing up to send in DNA for $99 from the DNA donor, but following the link leads to an announcement that the company is out of that business for a while.

[1] http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-...

Maybe you haven't seen what "clueless at the top" looks like.

It doesn't look like a successful company that's torn down by heavy handed regulators.

What's successful about 23andMe so far? (I'm asking genuinely, as the company is new, and I wonder what the benchmark for success that you have in mind is.)

That's a fair question.

They created a product/service that people willingly pay for and they do it on a large scale.

A clueless company looks like the guy that sent me a kickstarter link last week with copy that says, "The Next Big Thing" and it was a photo sharing application.

The leadership from Exhibit A tend to build companies like Google, McDonald's and Walgreens. You would have to be daft to consider them clueless.

The leadership from Exhibit B don't build anything of significance but do occasionally luck out, reinforcing a massive selection bias that fuels the next 100 startups that are just like it.

I just think that rhetoric is important on a site like HN. Calling someone clueless that did what we all want to do with our own endeavors seems pretty harsh. I know I personally feel for the management team tonight. It has to be hard to spend so many years building something great only to be smashed down by regulators.

Just in case someone didn't read the full article:

"Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had."

"Research is and will continue to be a significant priority for the company. The 500,000+ customers we have today have given us more than 250 million survey data points. You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014."

Its not like crowd-sourcing genetic correlations is ending. It just wont be expanding until this issue is resolved.

I feel really sorry for them too, but from the FDA's letter I got the impression that 23andMe just stopped working with the regulator altogether, even though they were given the opportunity to do so. If that is the case, that's really what I don't understand.

Bummer, I was almost ready to order one of the kits. Would have been fascinating.

I downloaded my raw data and took screenshots of my results just in case they get shut down. :(

I think this means I can scalp my pre-Nov 22nd, unused kit.

All kidding aside, this is pretty disappointing. I bought one for myself a year ago and it was a life altering experience. I know that 23andMe have come under scrutiny with regards to not only the accuracy of their findings but the manner in how they communicate it but I have not had problems with either.

I hope the FDA allows this company to continue what they are doing. It's rare that such an opportunity exists for the layman to understand their genetics.

EDIT: I've verified the more dramatic findings outside of 23andMe. I never saw 23andMe as an authoritative source, but it is a great guide.

It's only life-altering (in a good way) if the analysis 23andMe sent you was accurate, and many professionals in the field of the genetics say that it often is not. You say you haven't had problems with the accuracy of their findings, but unless you've had the test repeated by a research university, I'm not sure how you'd know.

Don't get me wrong - I want all this data for myself - but I don't want to be misled or falsely worried.

Well, that's ridiculous. I just bought a kit two days ago. I wonder if I should send the kit back then ask for the refund, or just send the kit back unused.

Reply on news.ycombinator.com