Because I am biased. At Geospiza, where I work, we make software products that help our customers, who do DNA testing, meet FDA and CLIA regulations. Since some of our customers do DNA testing for diagnostics and clinical studies, we are well aware of the regulatory issues that concern DNA sequencing and DNA sequence data. Most DNA diagnostics labs are regulated by CLIA, the Clinical Laboratory Improvement Act, with the diagnostic testing kits regulated by FDA (they’re a medical device).
Naturally, I wondered what interesting things would happen once the clinical regulatory groups started looking into personal genomics companies like 23andMe.
Now, it appears to no one’s surprise that 23andMe has learned that there are regulations governing what they do. Yes, if you diagnose disease, whether it be through DNA or a home diabetes test, telling people about their health risks is a health issue.
The explanation in the spittoon, 23andMe’s blog, is amusing:
Because 23andMe is creating an entirely new kind of business in delivering personal genetic information, the regulatory requirements we face are both complicated and uncertain.
I guess that’s short for “We didn’t do our homework, and it wasn’t our fault because we were confused.”
As far as the customers, Andrew Meyer is bummed since it’ll take longer for him to get results. Daniel has written about those who are impatient. And Steve Murphy (aka the Gene Sherpa) has the best post of all in CLIA? What’s that???
I guess the take home lesson, even for new technology, is that old cliche’: