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.
Mapping the Personal Genomics Landscape
Last week saw the first annual Genomes, Environments, Traits (GET) Conference, in Cambridge, Massachusetts. Timed to coincide with DNA Day 2010, the conference marked one decade since the publication of the draft consensus human genome sequence. The GET Conference was billed as “the last chance in history to collect everyone with a personal genome sequence on the same stage to share their experiences and discuss the important ways in which personal genomes will affect all of our lives in the coming years.” Not quite everyone with a public personal genome sequence attended – Craig Venter, Desmond Tutu, Glenn Close were all unavailable – but a majority of the genomic pioneers were in attendance and the GET Conference was a one-of-a-kind event.
For those who missed the GET Conference, several high quality recaps are available. The most detailed is A Day Among Genomes, by Carl Zimmer of Discover’s blog The Loom. More targeted reflections on the conference and related events come from Emily Singer of Technology Review summarzing key trends highlighted by the genome pioneers (Singer also has a related piece on the difficulties of understanding human genomes), David Dobbs of Neuron Culture on genomes, cool conferences, and what the hell to tell people about behavioral genes, and Turna Ray of Pharmacogenomics Reporter on the recent Myriad Genetics decision, and its impact on the business of patenting genes. If you’d like even more detail, the Twitter community provided real-time play-by-play.
While there’s no need for a further summary, the GET Conference does provide an occasion to look at the evolving personal genomics landscape in a more holistic fashion.
Past, Present and Future of Genomes, Environments and Traits: 140 Characters at a Time
The first annual Genomes, Environments, Traits (GET) Conference took place yesterday. The GET Conference was an incredible success, with panels, breakout sessions and presentations from all manner of genomic pioneers and futurists, as well as a tremendous audience, both in person and online. In the next few days I’ll share a few thoughts about what we learned at the 2010 GET Conference, as well as what we might expect by the time the 2011 event rolls around. There will also be video from portions of the GET Conference available soon.
In the meantime, if you missed the conference, there was plenty of live Twitter coverage. Everything I tweeted from @genomicslawyer can be found below, and there’s much more at the #GET2010 twitter notebook. Thank you to all those who helped cover the conference online, including GET Conference pioneers (Rosalynn Gill, Misha Angrist), moderators (Carl Zimmer, David Dobbs, Dana Waring Bateman), journalists (Edward Winstead, Emily Singer, Kevin Davies, Aaron Rowe), sponsors (Priscilla Oppenheimer), exome sequence winners (Jonathan Eisen) and many, many more.
Now for Genomes, Environments and Traits in 140 character snips:
Choosing to use genetic testing is an option. Ignorance isn’t.
Last week I posted a response to a column in the Sunday Times by Camilla Long, “Long’s Op-Ed on Personal Genomics Comes Up Short.” Readers of that piece may be interested in a further response (“Choosing to use genetic testing is an option. Ignorance isn’t“), which I wrote with Daniel MacArthur of Genetic Future, published today in the Times.
The New York Times vs. Personal Genomics: Much Ado About Not Very Much
Earlier this month, there was speculation that The New York Times was preparing a piece “attacking” the “fledgling industry” of personal genomics (see: Linda Avey Versus the New York Times). The article in question, by reporter Andrew Pollack, was published over the weekend and, in retrospect, it’s hard to see what all the hubbub was about.
The title (Consumers Slow to Embrace the Age of Genomics) fairly reflects the tone of the rest of the article, which is a factual assessment of the business of personal genomics. In his piece, Pollack brings forth a standard set of issues confronting 23andMe and its peers (including Navigenics, deCODEme and Pathway Genomics). All are familiar, and most drive at a central challenge for these companies: demonstrating the value of their services and identifying customers willing to pay for them. (In a short, separate article that appears alongside, Pollack raises (but does not attempt to resolve) a much more controversial issue: whether personal genomics products represent medical tests or recreational services.) By and large, Pollack points out these challenges to the business of personal genomics without passing judgment.
Long’s Op-Ed on Personal Genomics Comes Up Short
In an editorial in the Time’s of London’s Sunday edition – “When DNA means do not ask” – columnist Camilla Long took note of Glenn Close’s decision to sequence her genome. Long’s column begins with gossipy comments appropriate to her usual home turf (which is not science journalism). But she soon gets into territory clearly unfamiliar to her, focusing on what she perceives as the increasing commercialization of personal genomics and the broader failures of genetic information to provide satisfying explanations or cures for complex diseases.
Long’s column is a seriously one-sided and misinformed portrayal of not only personal genomics in the direct-to-consumer (DTC) context but also of the utility of genetic information in any context — clinical, commercial or otherwise. At Genetic Future, Daniel MacArthur’s response (“Willful ignorance is not an effective argument against personal genomics”) is every bit as accurate as it is scathing, and appropriately characterizes Long’s writing as “a true masterpiece of unsupported criticism, and an ode to willful ignorance.”
Why the State of Personal Genomics is Not as Dire as You Think
Another Tale of the Struggle of Personal Genomics, Full of Sound and Fury, Signifying…What? After a while, the personal genomics news cycle can begin to feel predictable. Recently, and not for the first time, there have been rumblings that personal genomics pioneer 23andMe is struggling. The most recent “news” appears to be a December SEC filing disclosing a $4 million payment to an unidentified 23andMe executive. Gene Expression and BNET have taken the opportunity to recycle some of the company’s previous financial struggles, including co-founder Linda Avey’s departure and a well-publicized round of fall layoffs, and to speculate broadly about the state of morale at the company in addition to the well-being of the personal genomics industry more generally.
Avey herself, perhaps unintentionally, has fueled speculation that something may be afoot with a pair of recent posts (the original post has now been combined with an update) on her own blog. Avey has launched a preemptive strike against what appears to be an upcoming New York Times piece that will “question[] the viability” of the personal genomics industry and “hits too close to home” for Avey not to comment. (Or, as GenomeWeb headlines it, Linda Avey Versus the New York Times.)
Perhaps all of the smoke signifies a smoldering fire at 23andMe. Then again, it may represent nothing more than periodic reverberations from the social media echo chamber, where common memes are repackaged and recycled at regular intervals.
Personal Genomics in the News: Desmond Tutu and the GET Conference
It’s been a busy twenty-four hours in the world of personal genomics. Yesterday, as announced in the journal Nature, the number of individuals who have had their genomes sequenced and made publicly available increased by two. Archbishop Desmond Tutu and !Gubi, a tribal elder from a Bushman (or Khoisan) community in Namibia, joined the ranks of personal genomics pioneers that include scientific and cultural luminaries such as James Watson, George Church, Skip Gates, Jr. and Stephen Quake.
Hot on the heels of the Nature paper (which has been exceptionally well-covered elsewhere, including by Not Exactly Rocket Science, the Technology Review, and the New York Times) comes this morning’s announcement that many of those same genomics pioneers, including Watson, Church, Gates, Quake and others, will be sharing the stage together at the inaugural GET (Genomes Environments Traits) Conference. From the conference announcement:
“The GET Conference 2010 marks the last opportunity in history to gather a majority of individuals in the world with public personal genome sequences in a single venue,” says George Church, founder and principal investigator of the Personal Genome Project and professor of genetics at Harvard Medical School. “With rapid advances in technology, the number of individuals with personal genome sequences is expected to rise dramatically, from dozens today to thousands by 2011 and a million or more individuals within the next few years.”
The morning portion of GET Conference 2010 will feature wide-ranging discussions during which personal genome pioneers and globally recognized leaders of genomic science and industry, including Misha Angrist, George Church, Jay Flatley, Henry Louis Gates, Jr., Rosalynn Gill, Seong-Jin Kim, Greg Lucier, James Lupski, Stephen Quake, Dan Stoicescu and James Watson, will share their experiences and discuss the future of personal genomics. Award-winning science journalists Carl Zimmer and Robert Krulwich will moderate the discussions.
Personal Genomics: A Participatory Activity
Last week the GLR covered deCODEme’s announcement that it was offering existing customers of its main competitor, 23andMe, the opportunity to have their genomic data interpreted by deCODEme’s own service. For free.
Although somewhat surprising from a short-term commercial perspective, I generally liked the move by deCODE as a means to improve the company’s genomic data interpretation abilities. Here’s what I wrote at the time:
If interpretation proves to be one of the key differentiators between DTC genomics companies, as expected, deCODE (and other companies) should embrace opportunities to hone their interpretative platforms now, while the DTC commercial market remains relatively small.
As both Peter Aldhous of New Scientist and Daniel MacArthur of Genetic Future have pointed out, it appears that there is some honing to be done on deCODEme’s end. From ancestry confusion to interpretative errors in evaluating Alzheimer’s risk, deCODEme’s first attempt at genomic data migration has been an imperfect one. Would deCODEme have preferred a seamless launch to their 23andMe data migration service? Of course. But if the experiment now pays off in smoother data migration and interpretation for the company in 2010 and beyond, these first bumps in the road will soon be forgotten.
CSHL and a Brief Survey on Genetic Testing for Psychiatric Diseases
As many readers are probably aware, Cold Spring Harbor Laboratory is presenting its second meeting on Personal Genomes next week. Freelance science writer and blogger Ginny Hughes will be speaking about the science and attitudes of genetic testing for psychiatric diseases. She’s prepared a very short survey on the topic so please help her out with a minute of your time.
