FDA

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Category archives for FDA

As part of his Gene Week celebration over at Forbes, Matthew Herper has a provocative post titled “Why you can’t have your $1000 genome“. In this post I’ll explain why, while Herper’s pessimism is absolutely justified for genomes produced in a medical setting, I’m confident that I’ll be obtaining my own near-$1000 genome in the…

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 noted at the time of its release, the report is an obscenely one-sided affair:…

In my previous post I quoted from Mary Carmichael’s excellent interview with two officials from the FDA, Alberto Gutierrez and Elizabeth Mansfield (part of her fantastic week-long DNA dilemma series, which you should read in full if you haven’t already). There are numerous nuggets of gold tucked away in this interview that warrant further analysis,…

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 operate. The rumour seemed plausible at the time, based on two pieces of evidence. Firstly,…

Following up on the rumours I posted about yesterday regarding a potential bid by the FDA to choke of direct-to-consumer genetic testing companies’ supply of genotyping chips, I received the following statement by email from 23andMe’s PR firm: 23andMe is engaged in an ongoing process with the FDA. 23andMe understands that Illumina is also engaged…

(Cross-posted to Genomes Unzipped.) Today’s US Congress Committee on Energy and Commerce hearing into the direct-to-consumer genetic testing industry was a vicious affair. Representatives from testing companies 23andMe, Navigenics and Pathway faced a barrage of questions about the accuracy and utility of their tests, made all the worse by the fact that many of the…

I mentioned last week on Genetic Future that a reporter with the Washington Post, Rob Stein, had emailed the National Society of Genetic Counsellors to search specifically for people with negative experiences of personal genomics for an upcoming article on the industry. At the time I called for personal genomics customers with positive experiences to…