Breaking: Congressional Committee Requests Additional Information Regarding 23andMe Sample Swap
Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics.
Today the Committee has followed up with another letter, this one directed to 23andMe president and co-founder Anne Wojcicki, inquiring into the circumstances surrounding the company’s recent and widely reported sample swap. The letter (pdf), which is signed by the same four Representatives (Waxman, Barton, Stupak and Burgess) requests the following:
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What Five FDA Letters Mean for the Future of DTC Genetic Testing
The FDA has published online letters sent to five personal genomics companies – 23andMe, Navigenics, deCODE Genetics, Knome and Illumina – informing the companies that they are manufacturing and selling medical devices without appropriate FDA premarket review and approval. No surprise that the news that the FDA has sent out letters to some of the most well-known providers of DTC genetic testing products is already making waves. (Daniel MacArthur was the first to point me to the AP story, and Mary Carmichael of Newsweek and Andrew Pollack of The New York Times were among the first to dive into the substance of the letters.)
Below, we will discuss the immediate and long-term implications of the FDA’s most recent regulatory actions for the five companies receiving letters, as well as for the DTC genetic testing industry. First, however, a review of the letters themselves is required. Each of the five two-page letters is signed by Alberto Gutierrez, Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), and follows a similar format throughout. To gauge the impact of these letters we will take them paragraph by paragraph.
Twitter Roundup
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:
- RT @markgfh: Robert Winston in @TimesScience, on why scientific ignorance is unacceptable: http://bit.ly/dzudDB
- Surprise: Genomic development & investor expectations not always on same timetable: http://bit.ly/bVSS6y (HT @ldtimmerman)
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Why 23andMe’s Sample Swap is Actually an Argument In Favor of DTC Genetic Testing
Direct-to-consumer (DTC) genetic testing company 23andMe made news this week thanks to a lab mix-up that left up to 96 customers reviewing genetic data that was not their own. Full details of the mix-up, and analysis of 23andMe’s response, are available from Daniel MacArthur at Genetic Future and Turna Ray at Pharmacogenomics Reporter.
23andMe’s sample swap follows close on the heels of the FDA announcing an investigation into Pathway Genomics and Congress launching an even broader investigation of the three leading DTC genetic testing providers. Not surprisingly, many commentators have pointed to 23andMe’s mix-up as just the latest example of the dangers of DTC genetic testing and further evidence of the need for greater federal regulatory scrutiny.
There are a number of reasons why DTC genetic testing may soon find itself subject to increased federal regulatory oversight. However, 23andMe’s widely publicized data error should not be one of those reasons. In fact, the sample swap, while unfortunately timed, actually presents a compelling argument in favor of the direct-to-consumer model for genetic testing.
Keeping Up With CODIS and Katie’s Law
A few weeks back, we posted a discussion of the issues surrounding the current system of forensic DNA profiling, with an emphasis on the Combined DNA Index System (CODIS). In that post, we noted that the federal government had enacted a policy of taking DNA samples from individuals arrested for certain crimes and retaining the samples in CODIS. To date, 23 states have enacted similar laws, and the federal government may soon give the other 27 states incentives to follow suit.
On May 18, the House of Representatives passed the Katie Sepich Enhanced DNA Collection Act of 2010, informally known as Katie’s Law.1 Under the bill, those states that collect DNA from individuals arrested for certain serious crimes (murder, voluntary manslaughter, serious sexual offenses or serious kidnapping offenses) and compare the samples to those in the CODIS database at least once receive a 5% bonus on certain federal crime prevention grants.2 States that also collect samples from individuals arrested for less serious crimes and submit all profiles collected from arrestees for inclusion in CODIS would instead receive a 10% bonus. The bill is now with the Senate Committee on the Judiciary.
Twitter Roundup
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:
- GPMA revived. RT @pgx_reporter: Kennedy/Eshoo Bill Tackles Hot Topics in Personalized Medicine http://bit.ly/bkiT4U
- RT @wilbanks Read this. RT @benadida: privacy *advocacy* theater http://tinyurl.com/35ypos2
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Is an IPO the Right Thing for Your Company?
This commentary in the Genomics Law Report’s ongoing series Bench to Market is contributed by David W. Dabbs, Robinson, Bradshaw Hinson, P.A.
You just spent the last five years of your life working virtually 24/7/365 to build your company into one of the most respected firms in its field. Three years ago you barely could raise enough money to fund payroll and rent. Now you barely have enough time to run your business because of all the meetings with investment banking firms that want to talk about taking your company public. You hear rumors about competitors going public, and your outside investors and board members tell you to strike while the iron is hot.
You wonder what it would be like to run a public company and how it will affect your lifestyle. Based on the valuation ranges under discussion, your net worth (on paper at least) makes you feel like you just won the lottery. Serious people are saying that you could be the “next Google,” and you wonder what that would be like. You imagine yourself ringing the bell on the New York Stock Exchange.
You decide to have dinner with an old college friend, who is the chief financial officer of a public company, to share your news (against the advice of counsel). What she says makes you think.
You ask her how much stock you should sell in your IPO, and she tells you that you will be told not to sell any stock. You wonder why, especially given that your private equity investor plans to sell part of its investment, and she tells you that public investors will view the sale of stock by you as a sign that you do not believe in the future of your own company. You ask her why the same rules don’t apply to your outside investor, and she laughs and tells you that they just don’t.
