Archive for the 'Law and Regulation' Category

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Personal genomics: a voyage of exploration

The last few months have seen the brave new world of personal genomics thrown into a state of turmoil, as the might of US federal regulators turns on this fledgling industry. There is no question that some level of regulation would be welcomed, to iron out the irregularities and squeeze out the fraudsters. But hidden somewhere in amongst the hype and the scaremongering are some real gems that we should not abandon lightly. Take note, please, Mr Regulator.

Some of the recent crop of consumer genomics companies are true innovators, pioneers attempting to navigate the treacherous complexities of modern human genetics. Their attempts at presenting complicated genomic and risk information in an accessible form have been exemplary. Is the information useful? For the most part, no. Is it harmful? Again, so far the answer is a resounding no. So what’s the problem? Speaking to numerous individuals who have had their genomes scanned reveals that most are notably under-whelmed by the experience – they didn’t learn much of direct use, and they haven’t changed their lifestyles. But individuals are free to chose to purchase these tests, or not, and to decide for themselves whether it is worth parting with their hard-earned cash.

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A sad day for personal genomics

(A reminder: posts on Genomes Unzipped represent the views of individual authors, not the group as a whole.)
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 Committee’s members seemed unable to distinguish between the more responsible companies in the field and the scammers and bottom-feeders. (You can read the written testimony of the speakers here, and Dan Vorhaus has a fantastic summary here.)
And the news for direct-to-consumer companies just keeps getting grimmer: the star attraction of the hearing today was a new report from a sting operation by the US Government Accountability Office (PDF), which details the results of anonymous purchases of kits from four DTC testing companies as well as assessments of marketing from 11 other companies approached by the GAO “both by phone and in person” without purchasing kits. While the companies are listed as anonymous numbers in the report, they were revealed in the hearing as (1) 23andMe, (2) deCODEme, (3) Pathway Genomics and (4) Navigenics (the remaining 11 remain nameless).
The report details a litany of complaints – ranging from the flimsy to the serious – about the marketing, reporting and scientific basis for the companies’ operations. Following hot on the heels of the two-day FDA meeting on lab-developed tests (see summaries from Dan Vorhaus here and here) and the recent warning letters sent to 14 more genetic test providers, this is a stunning blow to the nascent personal genomics industry.
Wait, there’s more
And it gets much, much worse: the report includes covertly taped conversations between GAO employees and several DTC companies, which I’ve embedded below. In this video, the company offering breast cancer advice is apparently Navigenics, and the company enthusiastically promoting non-consensual DNA testing for a customer’s fiance is Pathway Genomics. It seems safe to assume that the remaining companies on the tape aren’t members of the first four (reputable) testing companies, but rather of the still-anonymous 11.
Here’s the tape. Brace yourself:

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While You Were Meeting: FDA Mails Letters to 14 More Genetic Test Providers

(Cross-posted to Genomics Law Report.)

Earlier this week the FDA held a widely publicized two-day public meeting to discuss its planned regulation of laboratory developed tests (LDTs) (for more see: Day One Recap and Day Two Recap). Other than Monday morning, when the FDA presented background information on LDTs and some of the considerations that have pushed the agency to pursue a “risk-based application of oversight to LDTs,” the top agency officials at the meeting were conspicuously quiet. Elsewhere, however, the FDA was doing plenty of talking.

In letters dated July 19th, the first day of the FDA’s public LDT meeting, the agency continued its crackdown on direct-to-consumer (DTC) genetic test providers, mailing letters to 14 providers of genetic tests. A list of all 14 companies and tests appears below.

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