Creating hyperlinks between genes and research papers is not what I'd call diagnosing. You find evidence of ABCD gene, you search all research papers that cite ABCD, you curate and rank papers by quality, summarize related conditions with statistical correlations.

This is just a high-tech version of me using WrongDiagnosis.com, typing in 5 or 6 symptoms, and having it return all possible articles that cite those symptoms, ranked by number of simultaneous occurrences.

The potential hack to defeat the FDA here is to simply split the company in 2 parts.

Company #1 sells a $99 service which gives does the test.
Company #2 is a partner of Company #1 through an API. Consumers can elect to OAuth access of their gene data from Company #1 to Company #2.

Company #2 takes gene data over an API and sells you linked and ranked reports on it. Company #2 sells no devices, performs no tests. They are pure software bioinformatics. They take standard file formats and produce reports.

Consumers can elect not to use Company #2's services, get their own private data in raw format and write their own python scripts if they want.

Or, consumers can buy Company #2's services, but supply their own data from any company that offers personal genomics raw-data dumps.

The idea that me reading ranked reports to research papers linked to my personal health data is 'extraordinary claims' and a danger to me is frankly offensive. I would hope that a company offering software that parsed and processed genetic data and turned it into linked reports from crawled research papers could be considered a first amendment right.

But if not, the github approach is certainly a worthwhile approach.

Again, as I said in other posts, the FDA doesn't regulate supplements, doesn't regulate Dianetics/Scientology, didn't stop "The Secret" from killing people with heat-stroke therapy. It's enormously offensive to me that the government spends so much time going after stuff like this, pot smokers, et al, instead of massively beefing up enforcement over the hundreds or thousands of hucksters selling harmful bullshit health products on radio and late night TV ads.

Does no one remember http://en.wikipedia.org/wiki/HeadOn ?
Coldeze?
Five Hour Energy, which may have actually killed people, and still gets away with deceptive ads.

What about Hoodia? Yeah, the FDA advises people not to purchase it, but does nothing to stop consumers from buying it based on false claims of efficacy.

People don't like this style of reasoning, but in my opinion, the government regulatory agencies have limited resources. I want the SEC going after big banks and investment firms, not small time insider traders. I want the IRS auditing people who avoided millions or billions in taxes, not the guy who owes $1000. I want the FDA going after things which are much much more likely to be ripping off and harming consumers, either financially, or physically, and on the scale of possible things that can harm you, this is way way down the list based on a really loose theory of someone avoiding treatment by false negative, when in reality, if anything, the majority of people are going to be having more conversations with their doctor over this product.

It's like complaining about the people who lost under Obamacare and ignoring the fact that tens of millions more couldn't get any health insurance in the first place.