Calendar Posted Fri May 08 12:00AM

• The genetic testing company 23andMe had originally offered DNA testing to provide health, ethnicity, and genealogy information. 23andMe is the largest company doing this. They are approaching 1 million users. Sadly, my kit was not the 1.000.000th, but I may be close... :-) 

• In late 2013, the FDA banned 23andMe from delivering those health reports in the US, but 23andMe still offers health reports in Canada and the UK. 

Why? The basis for this FDA position may be that DNA interpretation is neither simple nor easy. This is a science still in its infancy, and is rapidly changing. Automated reports can be misinterpreted by the uninformed public. Only a medical expert can provide medical advice, and even the experts often disagree about some interpretations.

The DNA interpretations offered by 23andMe in their Health Reports, driven by experts, systems, algorithms and data proprietary to 23andMe, are considered a "Medical Device" by the FDA — and therefore can be regulated by the FDA. Really? That seems absurd, to me. The FDA worries that anyone could harmfully act on information in that Health Report without first consulting a doctor? How can any REPORT be considered a MEDICAL DEVICE? 

Why, FDA, are you being so conservative (draconian) on this? Let FREEDOM ring, it's OUR DNA, not yours!

Alternative Health Reports from my raw DNA data?

Meanwhile, the services offered by using the SNPedia crowdsourced database (open-source data, but from scientific peer-reviewed reports) are an interim substitute for the 23andMe Health Reports that were banned by the FDA. You can plug-in your data (downloaded from 23andMe) and run the health reports offered by Promethease. For $5 you get your results in a few hours, like a fast-lane, instead of waiting a day or so for a free report. SNPedia is updated often, from published DNA studies and scientific reports. The 23andMe Health Reports were different, and more polished, but for now, they are unavailable to us Americans here in the good old USA. Got any Canadian friends? I wonder what happens if you order from Canada but use the kit in the USA?

What else can I do with my DNA data?

There are many alternatives, like,,,,, and others for exploring aspects of health, or genealogy, or ethnicity, based on DNA information and scientific research. 

For Genealogy and Family Tree matchups, there are DNAgedcom, GEDMatch, and others that can use your raw DNA data (downloadable from 23andMe) and do stuff with it. Unfortunately, FTDNA (the second largest one, after 23andMe) does not accept the 23andMe data format — you must do another DNA test with them, which can cost about $40 to $100, or more, depending on options you can select and how many detailed DNA tests you want them to run for you. Some adoptees use this service to find long lost aunts, uncles, cousins, and perhaps their birth parents. There are Genetic Genealogy experts who can help them with this. 

What's next, for FDA and 23andMe Health Reports?

The FDA seems too far out of step with technology. Let me see the health reports that a cadre of experts have created for the 23andMe system, and decide for myself if it is worth some followup with an expert, or not. Who is overstepping here, the FDA or 23andMe? I'd say it's the FDA that is doing wrong. 23andMe was providing a useful service, at a reasonable price, for hundreds of thousands of their customers. 

What's next? Only the powers-that-be can know.

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