Will the FDA Regulate Just Genetic Risk Data, or All Risk Data?

The latest in the 23andme versus FDA saga, in which the FDA halted 23andme from offering health-risk analyses of the genotyping service the company sells, comes in a commentary published yesterday in Nature. The commentary’s authors, Robert Green of Harvard Medical School and Nita Farahany of Duke Law School, address a key question raised by the FDA’s […]

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23andMe Ceases Providing Health-Risk Info; Ancestry Only Now

The company announced today that in reaction to the FDA’s order to marketing health-related information based on its genetic testing, it will cease providing that information to anyone who signed on after the FDA sent its letter on November 22, 2013. MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–23andMe Inc., the leading personal genetics company, today announced that it […]

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Is The National Cancer Institute Telling Me to Remove My Breasts?

One of the key issues in the dust-up over the FDA’s insistence on regulating 23andMe’s service  is the question of how 23andMe’s health-risk results differ from other forms of health-risk information. Today, geneticist Joe Pickrell offers a sharp post that unpacks this a bit. He asks Should the FDA regulate the interpretation of traditional epidemiology? It’s a damned good question. Many online […]

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What Does the FDA Want From 23andMe?

Here’s a particularly sharp, context-rich post on that question from  from Margaret Curnutte, currently of Baylor University. It seems one of the more deeply informed takes on this fracas. A couple of the key points: On what 23andMe was offering: From its inception, [23andMe] has treaded a fine line between claiming to provide something that […]

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Embrace Your Dangerous Genome

Virginia Hughes is “sick of reading about the dangers of the genome.” So she complains over at Slate, eloquently, and I’m sick right with her. Hughes, who blogs at National Geographic and is among our sharper followers of genetics, doesn’t mean “dangers” as in hazardous habits of actual genomes: She means the overhyped danger of “The […]

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Choosing not to use genetic testing is an option. Ignorance isn’t.

Daniel McArthur and Daniel Vorhaus have a beef:
Earlier this month, the Sunday Times published an op-ed piece by Camilla Long critiquing the practice and business of direct-to-consumer (DTC) genetic testing (“When DNA means do not ask”). It is Long’s right, of course, to express her opinions, but the article is peppered with factual inaccuracies and exaggerations that demand correction.

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