Category: FDA
The recent Government Accountability Office report into the direct-to-consumer genetic testing industry certainly made a splash: it took centre stage at a Congressional hearing on the industry, and garnered media headlines about "bogus" results being generated by testing companies.As I...
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Posted by Daniel MacArthur at 9:45 AM • •
Category: FDA
An interview with two FDA officials in Newsweek reveals that the agency doesn't intend to regulate the release of raw genetic data to consumers - a reassuring outcome for genetic hobbyists. The interview also provides crucial context for a scare-mongering quote by official Alberto Gutierrez, apparently referring to the dangers of direct-to-consumer testing: turns out the tests Gutierrez referred to were neither direct-to-consumer nor genetic.
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Posted by Daniel MacArthur at 9:30 AM • 6 Comments •
Category: direct-to-consumer genetic testing
Two days ago I reported a rumour that the FDA might have convinced genotyping chip provider Illumina to stop providing its products to direct-to-consumer genetic testing companies - a move that would effectively prevent these companies from being able to...
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Posted by Daniel MacArthur at 5:30 PM • 1 Comments •
Category: commercial genetic testing
Investigations launched by the FDA and US Congress have potentially set the stage for a large-scale regulatory crackdown on the embryonic direct-to-consumer genetic testing industry. Such a move would be premature, and would do more harm than good to consumers. The industry needs to change, but a more careful, measured approach based on increasing the transparency of genetic tests is the best way forward.
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Posted by Daniel MacArthur at 9:30 AM • 9 Comments •
Category: FDA
An article in the Washington Post by reporter Rob Stein includes several "negative experiences" from personal genomics customers. The fact that so few such experiences could be found tells us something about the general satisfaction of customers with their personal genomic data - and a blogger claims that even these anecdotes have been exaggerated in the article for dramatic effect.
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Posted by Daniel MacArthur at 7:50 AM • 19 Comments •
Category: commercial genetic testing
The last week has seen the beginning of a likely massive regulatory crackdown on the personal genomics industry, with investigations into the field launched by the FDA and the US Congress. It seems likely that the result will be major regulatory burdens placed on the industry - an outcome that would do lasting damage to innovation in the nascent field of personalised medicine.
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Posted by Daniel MacArthur at 8:35 PM • 67 Comments •
Category: direct-to-consumer genetic testing
Germany's regressive new laws against direct-to-consumer genetic testing are transparently designed to avoid memories of eugenics and non-consensual medical experimentation - but restricting citizens from being able to access their own genetic information is not the right way to shake the horrors of the past.
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Posted by Daniel MacArthur at 5:15 AM • 19 Comments •
Category: personal genomics
Personal genomics company 23andMe is sponsoring a bill that would change the regulatory landscape of the direct-to-consumer genetic testing industry.
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Posted by Daniel MacArthur at 8:35 PM • 8 Comments •