• Clearly a long ways to go. RT @phylogenomics: YHGTBFKM: Science mag article on open data is not freely/openly available http://ff.im/-xKTil
• RT @genomesunzipped: A guest post on GNZ by @razibkhan about his own voyage of genomic self-discovery http://bit.ly/ghmIzQ
• RT @Sagebio: 80% of researchers have inadequate funds for data curation… http://bit.ly/gMVpC4
• RT @wilbanks: When patients share stories, health improves. replace (stories) w/ (data) and it’ll get even more true. http://nyti.ms/ie7DQ4
• RT @NatureNews: Proposal for new NIH center draws fire from US senators http://ff.im/-xKxmV
• RT @ldtimmerman: The geographic agnostic biotech investor, Steve Burrill, on why’s he’s coming to Seattle again. http://bit.ly/eWigkg
• RT @dgmacarthur: Review of genomics books by @MishaAngrist and @BioITEditor in @nature this week: http://bit.ly/fXiZ6T
• RT @matthewherper: Adriana Jenkins passed away. Please go read her call for personalized medicine. http://ow.ly/3UaIJ
• FWIW, ELSI issues get more time in key NHGRI grants (e.g., this one for clinical WES http://bit.ly/fl8DxR), even if an optional component
• Exactly. So why not give it more than lip service in plan? MT @drjonboyg: & i can guarantee ppl @ NHGRI considering those issues (incl me)
• True, but ELSI research also imp. If not NHGRI, who? MT @drjonboyg: not really point of the plan. NHGRI isn’t regulatory, we do research.
• ‘Tho concerned NHGRI plan devotes only single sentence (!) to IP, reg & reimbursement issues, DTC & genetic discrim. (2/2)
• Full text of NHGRI’s 10-yr plan (“Base Pairs to Bedside”): http://bit.ly/gjUuiF Seems fine overall; no major surprises or revelations. (1/2)
• RT @dgmacarthur: Couple seeks to use their dead son’s sperm and a surrogate mother to create grandchildren: http://bit.ly/e0EzkS
• RT @matthewherper: One patient’s dying wish: A law to make personalized medicine a reality. http://ow.ly/3TxDN
• Interested in the intersection of genomics & the law? @DukeIGSP has the fellowship for you: http://bit.ly/hT0tEb
• RT @dgmacarthur: If you want a primer on third-generation DNA sequencing technologies, check out @j_perkel’s piece: http://bit.ly/f6na9w
• RT @PHGFoundation: Pluripotent stem cells: patent pooling and HESC comparisons http://bit.ly/dUV2Ds
• I’ll be there too. More: http://bit.ly/gkr9dl RT @23andMe Attending FDA Public Advisory Comm. Mtg. on DTC Genetic Tests http://bit.ly/gMUtz1
• RT @dgmacarthur: One database to hold them all – a post on the confusing profusion of mutation databases: http://bit.ly/ePWrfY
• Nature Genome Decade op-ed (http://bit.ly/hcTpXe) notes key fight in ’01 was public/private access to genome data. Some things never change?
• RT @girlscientist: Nature’s turn this week: special issue on the 10-year anniversary of the human genome publication, http://is.gd/WMEGus
• Genomics From Base Pairs to Bedside: NHGRI’s new 10-yr plan: http://bit.ly/dXn897 @InSequence recap: http://bit.ly/gJujfv
• NYT tackles the PWC report & med-tech concerns: RT @BiotechPatent: “Medical Device Makers Shun US” http://nyti.ms/ih7HvV
• Guess no SOTU science funding boost RT @JohnCFierce: Aren’t these R&D jobs we want to support? Re: $74B in house cuts incl NIH ($1B)
• Re: House appropriations proposed cuts, FDA also slated to lose $220M. Not exactly a recipe for stepping up reg enforcement & drug dev…
• House announces $74B in proposed cuts: http://bit.ly/eKQVVL Biggest losers incl. NIH ($1B) & Office of Science ($1.1B) HT @shannonpareil
• RT @dgmacarthur: RT @EricTopol First “molecular autopsy” using whole genome sequencing to establish cause of death http://bit.ly/ffzPBN
• RT @tgoetz Just heard about @daniel_kraft’s new FutureMed program @ Singularity U. Sounds amazing! http://FutureMed2011.com
• RT @GenomeWeb_News: @Genomic_Health Reports 19% Revenue Growth for Q4, FY 2010: http://bit.ly/hUHEfz Driven by Oncotype Dx testing
• $ILMN continues to post strong revenue numbers. Q4 up 45%, topping even its own recent estimate: http://bit.ly/g7tXk4 @gw_dailyscan
• Seduce Health: What A Google Guy (@rzeiger) & Health IT CEO Are Saying to Put the Spark Back into Your Health Life: http://bit.ly/i15KOd
• A new paradigm, still w/ limitations RT @shwu acc to http://bit.ly/hzty0u, Coriell only uses 1 SNP/disease b/c multi-SNP models nt validated
• RT @pgx_reporter: Coriell, OSU Studying Whether Genomic Risk Data and Counseling Changes Patient, Doctor Behavior: http://bit.ly/dXi3xw
• RT @InSequence: At AGBT, Ion Torrent Customers Provide First Feedback; Life Tech Outlines Platform’s Growth: http://bit.ly/fgvJcZ
• What investors heard at #AGBT – summary & analysis from Amanda Murphy of William Blair: http://bit.ly/dXiQXS
• GLR Post: FDA Taking Another (Public) Look at DTC Genetic Tests: http://bit.ly/gkr9dl
• Re: CPMC genetic data/medical record integration, assume it will incl. only data for “potentially actionable conditions”? @GeneSherpas
• RT @dgmacarthur: Coriell PMC to add genetic data to electronic medical records for 10k patients: http://bit.ly/gzEU4y (via @GeneSherpas)
• REVEAL one year on: pros outweigh cons in genetic testing for Alzheimer’s: http://bit.ly/hYKHpc via @dgmacarthur @eurogene
• Jim Evans’ plan for genetic testing data: http://bit.ly/dWgirP Sounds like FDA’s plan for risk-based review of LDTs @dgmacarthur @drjonboyg
• RT @shwu: Life is definitely beautiful. “Painting the Genome for the Public” http://bit.ly/fnj19x
• More prognostication here: http://bit.ly/hNvufK RT @finchtalk: #1kgenome Q? How many genomes by 2011. Order mag. 10k, ES Millions by 2020.
• RT @Sagebio: “patients need to play active role in demanding data sharing” Eric Schadt #1kgenome
• RT @GenomeWeb_News: BBSRC Review Targets Challenges of Next-gen Sequencing: http://bit.ly/fUDKAs
• RT @ldtimmerman: Diagnostics biz models are improving b/c of fast/cheap DNA sequencing, says MDV’s Rowan Chapman. http://bit.ly/eGOHJ0
• Sen. Scott Brown attempting to repeal medical device tax: http://bit.ly/goL9Rs by @MassDevice
• The Human Genome (Patent) Project: http://bit.ly/hm3dTJ One of the most critical issues for *next* 10 decade of genomics
• And here’s a closer look at Mayo v. WebMD. Perhaps not quite so black/white after all? http://bit.ly/gc5hRr HT @daniel_kraft @DrVes
• Why MayoClinic.com > WebMD.com (to the point that the NYT recommends blocking WebMD): http://nyti.ms/hTYE1b HT @lukejostins
• RT @dgmacarthur: VERY useful list of 3rd party apps that can be used by @23andMe customers on their genetic data: http://bit.ly/griK7s
• RT @girlscientist: Rob Knight mentions Open Microbiome Initative, http://www.openmicrobiome.org/. #AGBT
• “Returning the Blessings of an Immortal Life”: http://nyti.ms/gkHKL7 Great work by @RebeccaSkloot & her foundation, helping the #HeLa family
• RT @GenomeWeb_News: Patent Reform Back on Senate’s Agenda: http://bit.ly/e4naF6
• RT @pgx_reporter: Medco Funds Pharmacy School at Fairleigh Dickinson University with Personalized Rx Focus: http://bit.ly/gZ3De4
• RT @OnlineBiotech: Linked electronic medical records for genomic research « ScienceRoll http://bit.ly/ftifU4
• RT @lukejostins @mndoci Strata videos live day after talks, AGBT has a default no blogging policy. Something in world of science not right
• RT @scotthensley: 2 cool reporting jobs at NPR DC: Food / Ag beat ; Money, Power & Influence in Science & Health. http://bit.ly/fNrX9g
• Retrying the “Bioethicists Can’t Handle the Truth” article from @reasonmag: http://bit.ly/fijR6B Having trouble with bit.ly recently…
• Genetic data return? It’s the bioethicists who “can’t handle the truth”: http://bit.ly/fijR6BEchoing by @RonaldBailey, @reasonmag HT @shwu
• RT @bmahersciwriter: More misconduct in Germany! MT @ivanoransky: Boldt investigation may lead to >90 retractions http://bit.ly/g8e9bO
• RT @genomesunzipped: A decade of genomics, 60 new genomes, parenthood and sharing genetic data, and more on data return http://bit.ly/gklf5S
• Re: @GenomeQuest: this is likely the future, separating sequencing & interpretation of WGS data. Big challenge for IP holders & regulators.
• At #AGBT, @GenomeQuest announces clinical diagnostic/analysis platform for whole-genomes/exomes: http://bit.ly/gFx0hR
• Does your twin have “rights” in your genome? @razibkhan explores: http://bit.ly/hMUBeg My $0.02 is in the comments.
• RT @Dwaringbateman: @genomicslawyer link re 13 ftball plyrs & breached med records didn’t work: here it is again: http://tinyurl.com/4cyobz2
• We’re now into year two of reflections on “The Human Genome Project: A Decade Later.” Now it’s Science’s turn: http://bit.ly/f27zBp
• RT @ldtimmerman: NanoString, snapping up Genomic Health veteran, seeks to prove economic value of cancer diagnostics. http://bit.ly/ey91MZ
• Those 13 Iowa football players hospitalized w/ rhabdomyolysis? Their health records were breached: http://es.pn/fxIS2y HT @danielg280

• RT @eurogene: Our paper: EU regs on personal genetic testing is now online at Eur J Hum Gen: http://bit.ly/fKliuQ
• RT @genomesunzipped: Good response to the Reader Survey so far, but we still need more data! MORE RESPONSES PLEASE: http://bit.ly/g8mqV1
• More on phylo, the genetic sequence alignment game RT @bioitworld: Coming soon: seq alignment on your iPhone? http://ow.ly/3iCzg
• RT @dgmacarthur: 180-sample study –> ignore. MT @mikesgene: Propensity for one-night stands may be genetic http://bit.ly/iiXNsZ
• The Scientist names $PCBB’s SMRT sequencing technology its #1 innovation of 2010: http://bit.ly/fC7nFN (HT @gw_dailyscan)
• Re: @markgfh & @MishaAngrist boldly going, @jasonbobe’s original piece on genomic astronauts is also worth a (re)read: http://bit.ly/fBmHO0
• MT @markgfh: To boldly go… and publish your genes: my column on @MishaAngrist’s fine new book & public genomics http://bit.ly/hLoK14 (£)
• Bummed I can’t make it! RT @virginiahughes: #NYCscitweetup is happening! next tuesday, dec. 7, here: http://bit.ly/9ON4L2.
• RT @GenomeWeb_News: BRL Teams with Mass General on PGx Tests: http://bit.ly/dZ4H2o
• RT @InSequence: NIH Finds Exome Sequencing Provides Answers for Some Patients with Undiagnosed Diseases: http://bit.ly/fhyHS9
• re: Phylo, first, H/T to @alliejanson for the link. Second, demo is wonderful, but having trouble registering / playing actual levels…
• Phylo, like FoldIt, is a great concept: combine games + research. Only this time it’s for sequence alignment: http://bit.ly/gzzS2w
• Surreptitious testing at State level: RT @MishaAngrist: Wikileaks docs: US wanted DNA samples of world leaders http://bit.ly/hgwDw6
• At long last (OK, OK – it was 1 wk) @mary_carmichael’s terrific profile of @geochurch is now online: http://bit.ly/i9YKZH
• Beware free stock advice. RT @dgmacarthur: Should you buy shares in Complete Genomics or Pac Bio, asks the Motley Fool: http://ping.fm/4AKmJ
• RT @ldtimmerman: More than 1/2 of biotechies surveyed by Pwc say politics has too much influence on FDA approvals http://bit.ly/gjSSuf
• Vermont law on drug data mining ruled unconstitutional: http://bit.ly/fEAgEk
• RT @genomesunzipped: The inaugural GNZ Reader Survey is now up. More answers == more data! http://bit.ly/g8mqV1
• GLR Guest Post: Jim Evans (UNC, SACGHS) on “Restricting Gene Patents: A Pro-Market Agenda”: http://bit.ly/fs0C4C
• $99 sale on @23andMe extended, apparently through 12/25: http://bit.ly/9useW At this point, anybody who winds up paying $499 will be upset
• Interview with Bob Cook-Deegan of @DukeIGSP on link b/w @creativecommons & genomics: http://bit.ly/b82zJz @PGorg pionners by using CC0
• “A Faustian Bargain” (or: “A Biochemist Defends the Humanities”): http://bit.ly/aN3Aff from @GenomeBiology
• RT @EdwardWinstead: In case others also missed: “The $1K genome, the $100K analysis?” by Elaine Mardis H/T @nutrigenomics http://j.mp/gsS7Ys
• RT @NatureNews: UK gov goes ahead with “patent box” tax scheme to encourage pharma investment http://reut.rs/fxw5cw
• Some wonderful examples of “participatory human research” that might not fly today: http://bit.ly/gydOBR Mental Floss v @David_Dobbs
• Absolutely. Need to move beyond “subjects” mindset RT @MishaAngrist: opportunity to reimagine human subjects research? http://nyti.ms/dGCNsm
• RT @dgmacarthur: MT @GenCounsNews: Focus on medical genetics and personalized medicine in new issue of Stanford Med http://bit.ly/eRNDKZ
• RT @wilbanks: Interesting paper on Human Genome Project, IP, innovation. Would *love* to get my hands on the raw data. http://bit.ly/gJqV8A
• Looking forward to it! RT @mndoci: Just ordered my @23andme kit, and it goes up on @genomesunzipped when I have had a chance to take a look
• RT @GenomeWeb_News: Advent Venture Partners Start Life Science Fund with $118M: http://bit.ly/hDqkvp
• If you’re looking for a valid @23andMe $99 discount code, might I suggest UA3XJH
• More on @23andMe’s new chip and product strategy from @dgmacarthur: http://bit.ly/e2Mynp (Plus a discount code if you read to the end)
• RT @DebbieKennett: Official announcement of @23andMe’s new one-million-SNP chip: http://bit.ly/gC8F2k For more: http://bit.ly/dTtche
• GLR Post: A Thanksgiving Tradition: @23andMe Repackages Product, Raises Prices: http://bit.ly/dTtche
• Separate health/ancestry products gone from @23andMe. Now 1 kit, $499 + $60/yr subscription (1 yr min). HT @MishaAngrist @DebbieKennett
• The article in the current issue of Duke Magazine by @mary_carmichael about @geochurch, @PGorg, etc. is fantastic. Sadly, not online (yet).
• Balancing public engagement & science: http://bit.ly/8XlvkZ HT to two who do this well: @MishaAngrist & @mary_carmichael
• Simple, wonderful. MT @ewencallaway: Looking for a genomic sequencer? Here’s your Google maps mash-up: http://bit.ly/dQjOGX
• The inaugural @genomesunzipped reader survey is now under construction. What questions would you like to ask/answer? http://bit.ly/icEpPo
• RT @WSJHealthBlog: FDA medical device review process: too fast, too slow, just right? http://on.wsj.com/dkel5K
• From basketball shoes to personalized medicine: the (Phil) Knight Cancer Institute at OHSU has $100M to spend: http://bit.ly/gb8OIr
• (I generally agree with Mike Cariaso’s take: genomes will be free in the end, although short-term bumps not out of the question.)
• RT @dgmacarthur: SNPedia’s Mike Cariaso argues in @bioitworld that FDA regs are unlikely to curtail genomic freedom: http://bit.ly/dg6sY3
• Helicos’ financial struggles leading it away from MDx & toward IP enforcement: http://bit.ly/bcAB5y (see also: http://bit.ly/9wuWsB)
• Wndrfl to see @mary_carmichael @ericneumann @alliejanson etc in Boston last wk. BTW, MA tweeps: @MishaAngrist is @ Harvard Coop tonight, 7p.
• Another (brief) update on the NIH’s genetic testing registry from @gw_dailyscan: http://bit.ly/cnpIfM Spring launch on tap.
• Globe’s gene patent op-ed (http://b.globe.com/9NTTGL) is balanced & accurate. Very well done.
• Congress, not courts, must fix flaws in gene-patent system – http://b.globe.com/9NTTGL HT @MishaAngrist
• GLR Post: Germany Struggles to Find Balance in Promoting, Regulating Genetic Technologies: http://bit.ly/aewjhb

• NinePoint Medical raises $33M for optical inspection of cancer cells during biopsies: http://bit.ly/d8EUHs by @Ryan_McBride
• Interview w/ Salzberg in @NatureNews re: open source BRCA screen: http://bit.ly/9RBQ0w A “poke in the eye” of Myriad, gene patents
• A first response to @Duncande’s Personalized Health Manifesto from @crossborderbio: http://bit.ly/cWQTje
• UK gov’t scraps 192 quangos, including Human Genetics Commission: http://bit.ly/a4afHw
• RT @Sagebio: Required Reading: Personalized Health Care Manifesto http://bit.ly/dqb3Al (nice job @Duncande !)
• Next #NYCscitweetup already in the works thx to @virginiahughes. Week of 12/6. Sign up here: http://bit.ly/bxdyVp
• RT @drjonboyg: Nature looks at the science policy implications of the midterms: http://is.gd/g0DEQ (h/t @mrgunn)
• RT @dgmacarthur: More good stuff from the @GoldenHelixInc team: how to include public genotype data in your study: http://j.mp/9UNmBk
• Ten years of genetics and genomics: what have we achieved and where are we heading? http://bit.ly/apUYVp (via @nature)
• Great Q&A by @pgx_reporter w GNZ’s @lukejostins on Building a ‘Personalized’ Genome Browser for Non-Scientists: http://bit.ly/bxcRrz
• Isolating the Elusive Management Gene: http://bit.ly/dzdMZO Can’t really tell if it’s tongue-in-cheek or a serious rant. Bizarre either way.
• RT @dgmacarthur: Great response to a daft article. RT @markgfh: @BobOHara pwns Oliver James on @GrrlScientist’s blog http://bit.ly/adZ9EX
• GLR Post: A Personal Genomics Update: http://bit.ly/cJknIJ
• Under Obama, a reinvigorated FDA (LA Times): http://lat.ms/a8EaNk
• Why public genomics is not a purely personal decision: http://bit.ly/cGH4o2 I talk with my family about joining @genomesunzipped
• Great #NYscitweetup! @LouWoodley @anthinpractice @BoraZ @virginiahughes @j_timmer @nparmalee @culturingsci @arikia @cassierodenberg @noahWG
• RT @GW_The_Sample: ACLA, AMP Try to Mold NIH’s Genetic-Test Registry: http://bit.ly/93zw23
• If FTC has received only 13 (minor) PHR breaches (all by $MSFT), does that indicate an absence of PHR users, of breaches or of reporting?
• FTC: No Major PHR Breaches So Far: http://bit.ly/bMUzPF $MSFT reports 13 minor breaches: http://bit.ly/9S6Gxv
• ‘Scrapers’ Dig Deep for Data on Web, including into @patientslikeme: http://bit.ly/9GNG2X H/T @girlscientist
• Multiplex cancer diagnostics: from Mass General (1.6k ppl) to Britain’s NHS (12k): http://bit.ly/9QAMml by @ewencallaway via @NatureNews
• Myriad’s BRACAnalysis ad campaign is “a glass half full” – improved education, but over-testing: http://bit.ly/9Vokf7 (HT @TheGenomeCenter)
• Why is @dgmacarthur releasing his DNA to the world through @genomesunzipped? Answer here: http://bit.ly/dvXQfB
• RT @blaine_5: I’m excited to join 999 others as one of the Personal Genome Project 1000k (PGP-1K)! http://tinyurl.com/2aewc2y #PGP1k
• On why Genomes Unzipped has more societal impact potential than opening a nude beach: http://bit.ly/atzZc8 from @razibkhan
• The full Nuffield report on “the ethics of ‘personalised healthcare’ in a consumer age” is here: http://bit.ly/a8tNgv (pdf)
• More on the Nuffield report on personalized healthcare from @PHGFoundation: http://bit.ly/bD9G7R
• Launch of the “PGP-1K”, more WGS data, Google Health integration & more in the latest PGP newsletter: http://bit.ly/bH2RJP
• RT @dgmacarthur: Nuffield: “not yet evidence that accessing genetic info without doctor’s supervision is harmful” http://bit.ly/cZpcZn (£)
• Steven Salzberg is in the news again, estimating the number of genes in the genome: http://bit.ly/9cQM2F (via @NatureNews)
• Trouble navigating @TimesScience pay wall for @markgfh’s take on @genomesunzipped launch? The Australian has it free: http://bit.ly/dpdNuv
• RT @dgmacarthur: Very nice – @dienekesp runs his homebrew ancestry calculator on our @genomesunzipped data: http://bit.ly/aQKgac
• GLR Post: A Do-It-Yourself Genomic Challenge to Myriad, the FDA and the Future of Genetic Tests: http://bit.ly/cLE65b
• By the way, H/T for JIM goes to Jillian Thiel of @C_G_S (http://bit.ly/aEmejo). Now have tickets for Thursday screening.
• Lorigen, thankfully, is an inventive tie-in for JIM: http://bit.ly/dpTP68 Has anybody seen the film yet?
• The Lorigen (“Better Kids, By Design”) website (http://bit.ly/9yZOCG) chillingly resembles actual, commercial websites.
• New Data Reveal University Startup Creation, Licensing Activity Strong Despite Economic Downturn: http://bit.ly/cjqnAW
• Should you crowdsource your medical problems? @MishaAngrist (& @Slate) investigate: http://bit.ly/baVDWO
• RT @matthewherper: resistant bacteria that used to be a problem for hospitals are now hitting schoolkids http://bit.ly/9O3YWe
• Indeed so RT @blaine_5: Looks like the GNZ 12 (http://tinyurl.com/22lb95n) are already available at SNPedia – http://tinyurl.com/23hh56n
• “Genomes Unzipped-the Naked Sequence” from @razibkhan: http://bit.ly/a6XsUT More on GNZ participation by implication coming this week.
• RT @markgfh: My report on the Geron trial: RT @TimesScience: First patient gets embryonic stem cell treatment http://bit.ly/aqx50o (£)
• RT @bmahersciwriter: MT @timohannay: exciting new Nature.com blog on data-intensive science, The Fourth Paradigm: http://bit.ly/9QWDn3
• The Biogang, Unzipping genomes & more from @mndoci: http://bit.ly/9GOHN6 We’ll be happy to take you up on your New Year’s resolution, Deepak
• RT @TimesScience: The DNA dozen: those less well-versed in genetics should be wary. Commentary by Christine Patch http://bit.ly/dwZjYI (£)
• RT @TimesScience: The DNA dozen: a chance to overcome DNA phobia, commentary by @MishaAngrist http://bit.ly/aMn9kN (£)
• Our genomes, unzipped: we’re making our genetic data public at Genomes Unzipped: http://bit.ly/GNZlaunch
• RT @TimesScience: The DNA dozen: 12 genetics experts share secrets of their genomes — warts and all http://bit.ly/bBbdpG (£)
• RT @rzeiger: PHR should be a *Participatory* Health Record #health2con #WhyPM
• Existence Genetics (@ExistenceG) and its plans to combine WGS with clinical genetic services: http://bit.ly/a6gCnW
• Venue? #NYCscitweetup on Tuesday 10/12 @ 7pm @LouWoodley @anthinpractice @npalmalee @brideyrevisited @TJ_Kelleher @j_timmer @noahWG @BoraZ
• RT @MishaAngrist: Cogent backgrounder on the FDA’s legal obligations in reg DTC genetic tests by colleague Jen Wagner: http://bit.ly/b90NtB
• MT @mary_carmichael: Most interesting thing (of many) abt @mattwridley’s piece is how ppl react-it’s a Rorschach: http://bit.ly/9pTW49
• RT @markgfh Whose genome is it anyway? w/ @dgmacarthur, Caroline Wright (@PHGFoundation), Mark Walport http://bit.ly/bnP8qr
• Steven Salzberg publishes an open-source DIY BRCA 1/2 test from WGS data: http://bit.ly/ab1zdN (via @dgmacarthur, @ewencallaway)
• FDA Launches Regulatory Science Initiative with Personalized Rx Focus Areas: http://bit.ly/bbERyt (via @pgx_reporter)
• Bayh-Dole, 30 years on. Are universities managing IP in the public interest? http://bit.ly/aZXLrj (via @ScienceInsider)
• A review of Kevin Davies’ (@BioITEditor) new book (The $1,000 Genome) from @23andMe: http://bit.ly/b8skgJ

• Well-designed genomics career resource from NHGRI: http://bit.ly/buhcbs Something for everybody on there. HT @GenomeWeb_News
• NIH Foundation, Biomarkers Consortium Team on Breast Cancer Trials: http://bit.ly/co1ZPq v @GenomeWeb_News
• Top Genomics Journalists: http://bit.ly/9LWjmR v @AccessDNA | Agree w/ entire list: @markgfh @tgoetz @emilysinger @matthewherper @Duncande
• RT @PGorg: PGP-100 enrollment starting now! And other news items: http://www.personalgenomes.org/newsletter/03.html
• Genomics Law Report: Evaluating the NIH’s New Genetic Testing Registry: http://bit.ly/a4NmCt
• A Personalized Critique of Comparative Effectiveness Misses the Mark: http://bit.ly/bUB9bD (from @crossborderbio)
• RT @EdwardWinstead: RT @NIHforHealth: News: NIH Announces Genetic Testing Registry http://bit.ly/alUJ5C
• Regulations, Clinical Utility & Personal Genetics: http://bit.ly/dmUnI2
• RT @FierceBiotech: Roche/Genentech try to develop companion diagnostic tests for all their experimental drugs. #RocheIR
• Hank Greely on the coming “Explosion of Prenatal Genetic Testing”: http://bit.ly/afzAVF (HT @GenCounsNews) Also: http://bit.ly/1nfDwM
• RT @MishaAngrist: Nobel Symposium: GENETICS IN MEDICINE June 15 – 18, 2010 lots of heavy hitters: http://bit.ly/a8xdzq
• Watch @RebeccaSkloot on #Colbert talking #HeLa http://bit.ly/crXEWq (at 15:40) Great interview; handles Colbert’s questions better than most
• Genetic Health Report Now Available from @PathwayGenomics http://cot.ag/aky1OH (v @Berci, @blaine_5)
• Headline should read “not cost-effective” instead of “not clinically useful”: Genetic Testing vs. Gail for Cancer Risk: http://bit.ly/dpU3kD
• RT @dgmacarthur: RT @ilanafish: ABC radio: Dr Caroline Wright on non-invasive prenatal diagnosis http://bit.ly/bSl7bi
• RT @bmahersciwriter: Fingerprints, DNA & fMRI, Oh my. Nature’s “Science in Court” special is live: http://bit.ly/9o55gO
• RT @ldtimmerman: VCs on politics: Officials who say they love biotech innovation are actually suffocating it. http://bit.ly/cFXyCP
• Nice interview by @humangenomeorg with @MishaAngrist. Reminds us that personal genomics is *personal*: http://bit.ly/cDVKDQ
• More on Myriad/BRCA patent dispute from @Duncande. Nice to see attempts at solutions other than ban/status quo http://bit.ly/adO2WY
• Canada moves forward with biosimilars, even as the US remains stalled: http://bit.ly/ayhFLp (via @crossborderbio)
• Consent, Privacy & Research Biobanks in Canada. Well-written policy brief: http://bit.ly/984s9z (HT @mikesgene)
• Duke researchers investigate “surprising breadth” of Myriad BRCA patent claim: http://bit.ly/c8diOr (HT @DukeIGSP)
• RT @dgmacarthur: Carrier testing company @counsyl has now raised almost $5M in venture capital: http://j.mp/9GClF8
• RT @wilbanks: RT @gkjohn: ‘Open’ Vs. ‘Public’ Data — The Big Difference http://ff.im/-hEq3m
• RT @ldtimmerman: Biotech maven Steve Burrill on how the IPO mkt still lousy, and how Dx will beat Rx in future. http://bit.ly/909GGr
• Free, yes. Payment creates ELSI issues. re: Stan Nelson’s comment – companies may pay you to be sequenced (@dgmacarthur @bioitworld) #XGen
• What the FCC’s Broadband Report Means for Genomics and Personalized Medicine: http://bit.ly/bfybKm
• Presage Raises $3M on strength of new model for predicting which cancer drugs will succeed: http://bit.ly/aNi7Cb (by @ldtimmerman)
• Drugs Are For Sick People: http://cptl.st/aPPMuK by @matthewherper
• RT @crossborderbio, @JohnCFierce: VC funding for life sciences $1.9B in 4Q, flat from 3Q, but biotech VC rounds swell. http://bit.ly/9Q5jOZ
• MedCo/Mayo study continues to press the case for genetic testing in Warfarin prescribing: http://bit.ly/d3wKmM (HT @tgoetz)
• Long’s Op-Ed on Personal Genomics Comes Up Short: http://bit.ly/clB4E3
• The Texas Newborn Bloodspot Saga has Reached a Sad – and Preventable – Conclusion http://bit.ly/cbI8he
• GPPC DTC genetic test list (last tweet) is helpful, but far greater specificity w/r/t price, SNPs tested, quality of testing, etc. needed.
• Genetics & Public Policy Center updates its DTC genetic testing lists by both company & disease: http://bit.ly/8YKYv5
• RT @Scitable: Human Egg To Be Raffled Off http://bit.ly/d4woqQ
• I’m sure @GeneSherpas will be glad to see this. RT @23andMe, @KQEDScience: “23andMe Not Just for Fun Anymore” http://bit.ly/99WbVO
• “To Stop Crime, Share Your Genes” http://nyti.ms/ao3SDB NYT Op-Ed Argues for a national forensic DNA database.
• Obama Supports DNA Sampling Upon Arrest: http://bit.ly/cfg67K (Wired, v @cheriewoodward) Already occurring at FBI, appox 1/3 of states
• RT @mobilehealth: iPhone medical app the FDA took down: “We have never been involved in anything so peculiar…” http://tinyurl.com/ybl8tlo
• Willful ignorance is not an effective argument against personal genomics: http://bit.ly/cwc5J5 (by @dgmacarthur; well done)
• RT @dgmacarthur: RT @lukejostins: Very nice perspective on common-vs-rare variants and GWAS by p-ter over at GNXP http://bit.ly/aaMELy
• FDA Announces New Warning for Plavix linked to genotype http://bit.ly/9LdAVR (HT @GeneSherpas)
• RT @mikesgene: In a room full of geneticist / genetics related academic, gov’t & industry, only 4 have had a DTC genetic test. #genomics
• RT @dgmacarthur: RT @mikesgene: Geneticist Bob Church notes the bioethics we have been using for 25 years are now almost useless.
• Personalized Medicine, Genetic Testing and PBMs. Good top-level view from Bloomberg: http://bit.ly/bisRo3 (HT @westr)
• RT @BiotechPatent, @Xconomy Genetix Pharma Raises $35M from Third Rock, Genzyme for Gene Therapy http://bit.ly/9dd7dK
• Is this one for @phylogenomics’ worst ‘omics’ award? RT @FurnoX: Celebrogenomics – Illumina sequences Glenn Close http://ow.ly/1hbNS
• RT @chiah: “Transparent and open data does not equal USEFUL! (you have to build data visualization!)” @lostonroute66 #sxsh
• RT @NatureNews: Pharma to FDA: Let us keep tweeting, just w/ little logos & side links re safety & adverse effects. http://bit.ly/bgNmZW

Given deCODE’s recent financial struggles, this latest development is hardly a surprise. Indeed, two months ago, we anticipated this very event when we asked a hypothetical question: “What Happens if a DTC Genomics Company Goes Belly Up?” That’s precisely the question that deCODE’s customers and creditors are asking today.

In our original article, which was initially published in three parts on September 14, 15 and 16 at Genetic Future, we looked at the interplay between the privacy policies of DTC genomics companies and the relevant bankruptcy law statutes, and offered some educated guesses as to how courts and companies would handle the sale of a bankrupt company’s sale of its customers’ genetic information.

The coming weeks will see that analysis tested in Delaware bankruptcy court. In the meantime, there is a lot to unpack in this morning’s deCODE announcement.

deCODE’s New Owners. deCODE’s proposal is to sell one of its key operating subsidiaries, Islensk Erfdagreining (IE), as part of its plan of liquidation. According to the announcement, “IE conducts deCODE’s human genetics research, manages its population genetics resources and provides its personal genome scans, DNA-based risk assessment tests, and genomics services for contract customers.”

What this means is that, when the dust finally settles, there will be a new management team running a majority of deCODE’s current operations, including the DTC genomics service deCODEme. It’s likely that the new ownership will be the “stalking horse” buyer Saga Investments LLC, an investment company whose owners include Polaris Venture Partners, ARCH Venture Partners and genomic sequencing giant (and DTC genomics dabbler) Illumina. However, under Section 363 of the Bankruptcy Code, other interested acquirers, if there are any, have a chance to see what Saga is offering and swoop in with a higher bid. And, as we discussed in our original article, even if there are no higher bidders the bankruptcy court still must approve the sale to Saga. (For those that are interested, here are the Stalking Horse Agreement and Schedules.)

Whether Saga or another group of investors winds up in control of the company, today’s announcement is likely to herald a changing of the guard at deCODE. Co-founded in 1996 by Kari Stefansson and Jeffrey Gulcher, both accomplished scientific researchers, deCODE genetics’ roots stretch back to a time long before “DTC genomics” was crowned TIME’s invention of the year in 2008 and the consumer-focused genetic testing field filled up with competitors such as 23andMe, Navigenics and Pathway Genomics.

It’s to be expected that an industry as new and unproven as DTC genomics will see its fair share of upheaval, and the last four months have seen plenty: the arrival of Pathway Genomics, turnover and a recent and unexpected product restructuring at 23andMe, and now deCODE’s bankruptcy and sale. Yet to be determined is whether these are the signs of a healthy industry reacting to the combination of increased competition and a struggling broader economy, or an indication that existing DTC business models need to be thoroughly revamped.

deCODE’s Old Customers. It remains to be seen what a new set of owners will bring for deCODE’s existing customers, especially those of its deCODEme DTC service. Genetic Future posted a letter this morning sent by deCODE to its deCODEme customers. The company assures its customers that, as part of its bankruptcy filing, it has secured funding that it will allow it to maintain its operations and that “we do not expect [the bankruptcy] to have any impact on your deCODEme account.” (emphasis added)

To some extent that’s true. The arrangement with Saga provides bridge financing of up to $16.5M for deCODE. That funding should allow deCODE to keep the lights on and otherwise maintain its operations as it proceeds through the bankruptcy process. Clearly, changing owners doesn’t change the science that will continue to drive the deCODEme analysis.

But behind the scenes, changes are certainly possible. Any bankruptcy filing is a final admission that the current business model is broken, although it’s often very difficult to tell from the outside just which pieces of the business model aren’t working. The deCODEme portion of the business might be operating satisfactorily. However, if deCODE’s new ownership determines that one of the necessary changes is an overhaul of its deCODEme business model, including whether and how the company uses its customers’ genetic information, it won’t be free to do so with unfettered discretion.

As we discussed at length in our earlier article, deCODE’s existing data access restrictions, as well as other restrictions imposed by law, will limit the available uses of customers’ genetic information by the new management. Those restrictions will define a range of permissible uses for genetic information that is transferred as part of the bankruptcy sale. Within that range of allowable uses, however, deCODE’s new owner may choose to change or even expand its use of that information.

deCODE’s Current Investors. deCODE genetics, Inc. is a publicly traded company (NASDAQ: DCGN) and the analysis for deCODE’s current owners is simple and unappealing. From the press release: “In the event of a liquidation, any recovery for stockholders of deCODE would be highly unlikely.”

Expect more commentary and analysis from the GLR in the days and weeks to come as the deCODE bankruptcy proceedings continue to unfold.

This is the third of four related posts analyzing 23andMe’s decision to separate its health and ancestry DTC genetic testing services. For more please see 23andMe’s New Game Plan: What it Means for the Company and for DTC Genetic Testing, A Fundamental Right to Genetic Information (Now More Expensive Than Before) and DTC Genomic Research: Revolution or Minor Uprising?

For well over a year, the DTC genetic testing industry in general, and 23andMe in particular, has been undergoing a shift in the way it characterizes and promotes its offerings. Where they once focused on the educational and recreational features of their services, DTC companies have rolled out an increasing array of tests and reports that appear unambiguously aimed at influencing their customers’ clinical or medical decision-making.

For example:

With the launch of the 23andMe Health Edition we are releasing 13 new carrier status reports. These reports will help you know more about what may be in store for the next generation. We are expanding our cystic fibrosis panel report to cover the full panel of mutations recommended by the American College of Medical Genetics, as well as several additional mutations. We will also be providing data for most of the mutations routinely screened for in the Ashkenazi Jewish population, including those associated with Tay-Sachs disease, Canavan disease and Bloom’s syndrome.

This isn’t 23andMe’s first foray into carrier screening (although the expanded screening brings 23andMe more in line with the DTC carrier screening service offered by Counsyl), and the company’s critics, including Steve Murphy, have already argued that the services 23andMe provides are medical in nature, and should be regulated as such.

Recreational or Medicinal? At least publicly, however, 23andMe continues to maintain that its services are “for research and educational use only.” The company’s Terms of Service prohibit the use of 23andMe’s services for “health ascertainment or disease purposes.”

From the Terms of Service:

3. Description of What the Services Are and Are Not: 23andMe Service Is For Research and Educational Use Only. We Do Not Provide Medical Advice, And The Services Cannot Be Used For Health Ascertainment or Disease Purposes

The genetic information provided by 23andMe is for research and educational use only. . . . The Services Content is not to be, and is not intended to be, used for any diagnostic purpose and is not a substitute for professional medical advice. . . . [O]ur testing service is not licensed by the relevant state and federal authorities for genetic testing conducted for health and disease-related purposes. Reliance on any information provided by 23andMe, 23andMe employees, others appearing on our website at the invitation of 23andMe, or other visitors to our website is solely at your own risk.

23andMe is not alone. The Terms of Service for other DTC service providers such as Navigenics and Pathway Genomics contain remarkably similar legal disclaimers.

Despite the disclaimers, and despite the fact that these companies are in most respects neither licensed nor regulated in the same way as traditional clinical or medical genetic testing companies, it is becoming increasingly difficult to distinguish the services offered by 23andMe and their DTC competitors from those offered by traditional medical genetic testing facilities.

Key Questions for DTC Genetics. In looking at the DTC genetics space a few key questions continue to crop up:

1. Are these companies conducting medical genetic testing?
2. If so, should they be regulated differently than at present?
3. More importantly, will they be regulated differently and, if so, by whom?

Based on most common understandings of “medical genetic testing,” it is becoming increasingly difficult to give anything other than an affirmative answer to the first question. For example, as of today’s writing, 23andMe provides “Clinical Reports” for 33 conditions and conducts the relevant genotyping in a CLIA-certified laboratory environment, a requirement for traditional clinical genetic testing laboratories.

But covered as they are by a patchwork quilt of inconsistent and overlapping legislation and regulation, whether and how any of these DTC genetic companies might be arguably in violation of the letter of the law is a case-by-case – as well as, more often than not, a state-by-state – determination.

It is this uncertainty that makes the final two questions – whether these companies should be regulated and, if so, who will take on that responsibility – so important.

As for the should, it’s still not clear that, even if they are offering medical genetic testing, companies such as 23andMe are posing a risk to either consumer or patient safety that requires increased regulatory activity. Policy considerations such as the legitimate interest of individuals in obtaining direct access to their genetic information and a desire to foster the growth of an emerging commercial field to speed the development of technology as well as consumer awareness of the benefits of genetic testing are balanced against sincere concerns by clinicians that their patients may be misled or harmed by inaccurate or incomplete genetic information. The scale does not appear to have tipped definitively in either direction.

While other countries, most notably Germany, have taken definitive action to address various elements of DTC genetic testing, regulatory and legislative activity in the United States has been minimal. More than 18 months after a lengthy and influential government advisory report on the topic (pdf), a handful of letters in New York and California continue to stand as the most significant domestic (and public) regulatory activity.

There has certainly been no shortage of proposals seeking to address various pieces of this puzzle. These include the development of a mandatory genetic testing registry (also here), recommendations for industry self-regulation (pdf) or the appointment of a neutral, international organization to ensure standardized data and risk calculations, demands from clinicians to greatly expand regulation of the entire field, and even legislative action that would have the practical effect of banning direct-to-consumer genetic testing entirely.

Yet still we wait.

Hedging its Bets. Even in a climate of both regulatory and commercial uncertainty, companies such as 23andMe have no choice but to continue to move ahead, balancing commercial and legal risk to the best of their abilities. In July, when Pathway Genomics announced its own bifurcated product offerings, I wrote the following:

Pathway’s launch reflects a new wrinkle in how the industry may attempt to respond to the anticipated regulation of clinical genetic testing. Differentiating its recreational and clinical products from the outset could be just the sort of subtle but significant decision that would allow Pathway to quickly adapt to any regulations that distinguish educational or recreational uses of genetic data (such as genealogy) from clinical or medical uses (such as disease, pharmacogenetics or carrier testing).

Whether or not it proves possible to maintain a recreational/clinical distinction from either a scientific or a regulatory point of view remains to be seen, but Pathway appears to be doing what it can to provide itself with the flexibility it will need to navigate a complicated and rapidly evolving DTC genomics landscape in the coming months and years.

In the four months since Pathway’s announcement, there have been no significant changes in the regulation of the DTC genetic testing space. In that regard, at least, the decision to offer separate DTC genetic testing services makes every bit as much sense for 23andMe today as it did for Pathway in July.

Additional regulatory activity in this space is unlikely to be swift or dramatic, but by adopting a more flexible model for its product offerings 23andMe is better prepared today than it was last week to weather those changes, whatever they may be.

Just Who Do You Think You Are? Finally, buried in the comments to Daniel MacArthur’s coverage of the 23andMe announcement is a link to what purports to be an anonymous employee review of 23andMe from the website glassdoor.com. There are good and obvious reasons not to put too much stock in anonymous reviews, despite GlassDoor’s attempts to ensure legitimacy.

Nevertheless, it’s a detailed review that raises some tough questions, particularly in the final paragraph:

My advice is to build a company that focuses on doing one thing very well. If that thing is a web portal for genetics content, then set aside the research goal. If that thing is research, then set aside the web portal. If it is a genome-wide diagnostics company, then do whatever it takes to succeed in the increasingly difficult diagnostics world. . . .

Is 23andMe trying to do too much? That’s a legitimate question to ask of a company that has brought tremendous innovation and excitement to the field of DTC genetic testing but, at least so far, no obvious commercial success.

It’s possible to imagine that 23andMe will succeed in pursuing all of its various objectives – including providing genetic genealogy services, genetic testing for health, disease and other traits, improved genetics education and a novel genetic research platform – but it’s also certainly reasonable to ask whether 23andMe is trying to do too much.

Separating its genetic testing offerings onto separate product platforms, in addition to providing regulatory flexibility, also helps provide 23andMe and its investors with improved commercial flexibility. Segregating its products paves the way for 23andMe to develop more specific brand recognition and even to spin off or scale back portions of the company if that turns out to be a useful option down the road.

This is the fourth of four related posts analyzing 23andMe’s decision to separate its health and ancestry DTC genetic testing services. For more please see 23andMe’s New Game Plan: What it Means for the Company and for DTC Genetic Testing, A Fundamental Right to Genetic Information (Now More Expensive Than Before) and The Open Secret of DTC Medical Genetic Testing.

In sifting through all of the discussion surrounding 23andMe’s newly separated health and genealogy services I noticed one other interesting piece of information by omission: the $99 Research Edition appears to have recently disappeared from 23andMe’s product line.

In July, 23andMe announced a “new research model [that] makes it possible for large groups of people to assemble themselves into large-scale genetic studies without having to raise millions of dollars in funding, and then wait years for things to get rolling.” Termed the Research Revolution, the model was simple:

• Purchase 23andMe’s service. In addition to its standard $399 service, 23andMe also offered a $99 Research Edition, a stripped down version of 23andMe’s full service, which provided customers with limited information about variants associated with genetic diseases and other traits, but left out reports on carrier status, drug response and genetic ancestry and did not include access to raw data.
• Pledge Support for a Disease. Both new and existing customers had the opportunity to determine the disease(s) most worthy of study by pledging their support to one of 10 diseases.
• Wait for Critical Mass. In return for its customers’ support, 23andMe pledged to “. . . do research on any disease that enrolls enough patients to ensure a productive study. The research will be conducted by 23andMe scientists, working with outside researchers who have expertise in the particular topics being studied.” When the project was announced, 1,000 patients was determined to be the threshold for “enough patients to ensure a productive study.”

But a funny thing happened on the way to the Research Revolution: there weren’t enough revolutionaries. Periodic checks of 23andMe’s progress page over the summer and early fall made it clear that reaching 1,000 patients for any of the 10 listed diseases was going to take considerably longer than expected. Or a change in the rules of engagement.

Re-visiting the Research Revolution progress page over the weekend I was surprised to find the following announcement:

The first phase of Research Revolution concluded on September 30th, 2009. We have a clear winner — Migraines, with more than 200 patients and 500 supporters. To follow through on the commitment to start a research study, our science team has developed a survey on headaches that is now available to all 23andMe users. We will analyze the survey response data to hunt for clues to the genetic causes of migraines.

For a company known for its creative marketing, the completion of the first phase of the Research Revolution was conducted without any noticeable publicity. Not even 23andMe’s corporate blog, the Spittoon, made mention of Migraines’ victory. The company did announce a new migraine headache survey in mid-October but, oddly, there was no reference to the Research Revolution.

Even more intriguing than Migraines’ silent victory in the Research Revolution race is 23andMe’s decision to move the finish line. As this screenshot posted by TechCrunch shows, 1,000 patients (not just supporters) was the original threshold for enabling a research study for a complex trait such as migraines. But that was July. By September, with Migraines not even one quarter of the way to the finish line, a “victor” was declared.

As with 23andMe’s restructuring and re-pricing of its services, the changes to the Research Revolution model raise questions about the company’s evolving strategy. Did 23andMe overestimate the level of interest for customer-driven research? Is its failure to approach 1,000 supporters – not just patients – for any of the 10 listed conditions indicative of more widespread difficulties attracting paying customers? And, most importantly, are 200 migraine patients and 500 supporters enough to conduct meaningful genetic research, let alone qualify as a Research Revolution?

There’s no question that 23andMe continues to pursue innovative approaches to participatory genetics research. But at this point it remains unclear whether sufficient numbers of paying customers are willing to come along for the ride.

Claim 1 in Prometheus’ U.S. Patent number 6,355,623 claims “a method of optimizing therapeutic efficiency for treatment of an immune-mediated gastrointestinal disorder.” The method comprises “administering” a specified drug to a patient and then “determining” the level of the drug in the patient. The remainder of the claim specifies threshold levels of the drug’s metabolites (the chemical products of metabolism in the body) in the patient’s blood below which the dose should be increased (because of lack of efficacy) and above which it should be decreased (because of potential toxicity).

Bilski involves a business method patent, but its logic also applies to diagnostic and therapeutic methods. Under Bilski (at least as it now stands), the method must either be tied to a particular machine or transform an article into a different state or thing—hence the shorthand “machine or transformation” test. The question in Prometheus was whether the claimed method satisfied the transformation branch of the test. The Federal Circuit, reversing a ruling by a federal district court in California, held that it did.

The Federal Circuit found that both the “administering” and “determining” steps in the patent brought about sufficient transformations. In the administering step, “The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites.” At the determining stage, the court found that measuring the levels of drug metabolites in the body “necessarily involves a transformation, for those levels cannot be determined by mere inspection.” Transformative methods might include high-pressure liquid chromatography or the extraction of metabolites from the body. Apparently, the transformation at either the administering or the determining stage would have been sufficient to satisfy Bilski.

The court also dismissed other objections to the patent based on language in Bilski and its predecessor cases. In response to the argument that the claims merely covered natural correlations (laws of nature, which are not patentable subject matter) and data-gathering (also not patentable), the court held—sweepingly—that “The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” It also held that the presence of “mental steps” (a red flag in a method patent) in deciding how to respond to the metabolite levels did not negate the transformation that occurred. Finally (dismissing another red flag), the court found that the patent did not “wholly preempt” the use of correlations between metabolite levels and efficacy and toxicity.

An interesting legal aspect of the case is its consistency with a couple of older Supreme Court cases dealing with whether software-based inventions were patentable subject matter. In 1978, in Parker v. Flook, the Court rejected a claim to a “method for updating the value of at least one alarm limit” in a catalytic converter that involved the repeated measurement of temperature and the repetitive calculation of a known equation with the newest temperature reading. But three years later, in Diamond v. Diehr, the Court allowed a claim to a “method of operating a rubber-molding press . . . with the aid of a digital computer” that involved the repeated measurement of temperature and the repetitive calculation of a known equation with the newest temperature reading. The only difference between the two seemed to be the claim language: Flook (invalid) claimed the measurement and calculation process itself, whereas Diehr (valid) claimed an industrial process that involved an indistinguishable measurement and calculation process.

It seems that Prometheus is putting similar emphasis on the claim language. Although the Prometheus claim involves measurement, correlation, and interpretation of significance, it is framed as a method of performing a therapeutic intervention—a treatment. As the Federal Circuit held, a method of treatment is “always transformative when a defined group of drugs is administered to the body” (my emphasis). So the various mental steps are folded into a conventionally patentable process (as in Diehr) as opposed to being the essence of the claim (as in Flook).

In one sense, this is an invitation to semantic gamesmanship: hide what are essentially claims to measurement, correlation, and interpretation—pure mental steps—in some nominal physical activity and you survive section 101. But there is more to it than that. The act of framing mental steps in transformative activity limits the scope of the patent. Prometheus does not own the mental processes, just the use of those processes in this particular therapeutic method.

Patent lawyers will argue about how significant or trivial this limitation really is, and their positions will largely depend on whether they think patents like this help or hinder the progress of medicine. The Prometheus decision is likely to make it easier to patent other kinds “personalized medicine” interventions. Any kind of treatment that changes the body or its contents in some way should be found to be transformative and thus patentable subject matter (but again, it still must be novel, useful, and nonobvious). The status of interventions that are merely diagnostic—for example, methods for finding genetic mutations—is less clear. On the one hand, it seemed important in Prometheus that the claim was to “a method of optimizing therapeutic efficacy.” But on the other, the court did hold that measurement involving more than “mere inspection” is itself transformative, which would seem to open the door to just about anything.

For the record, my own view is that the Federal Circuit (and the Supreme Court, should it take the case) will have second thoughts about just how widely it has opened the subject matter door. I predict (or at least hope) that future cases will worry about the impact of this sort of method patent on medical practice and research and look for ways to limit Prometheus, maybe by focusing on the therapeutic aspect. But don’t bet the house and the dog on this or any other outcome just yet.

Direct-to-consumer (DTC) genomics companies are not immune to the current recession. When TruGenetics, a new player in the DTC genomics space, announced in June that it would be handing out 10,000 free genome scans, both Genetic Future and the Genomics Law Report raised questions about the financial viability of its business model, particularly in the current economic climate. Sure enough, on August 21, TruGenetics announced that it had been unable to secure funding sufficient to support its business model as contemplated. Frequent readers know that TruGenetics is not the only DTC genomics company that is struggling. The financial struggles of deCODE Genetics have been well chronicled (see here, here and here) and even new market leader 23andMe has undergone a dramatic shift in its top management as it pursues a new round of financing.

Ultimately, it was a recent headline here at Genetic Future—“deCODE Genetics on the brink of insolvency”—that started us thinking: what would happen if an established DTC genomics company actually went bankrupt? More specifically, what would happen to the genomic (and other) data held by the company? Genomic data is likely to be the company’s most valuable asset. Can that data be sold off to help meet the company’s debts? Bankruptcy can be a confusing and arcane process, with real risks and uncertainties for companies, their creditors and their customers.

In today’s post—the first of three on this subject—we examine the privacy and confidentiality policies of several leading DTC genomics companies to find out what, if anything, they have to say about whether data can be transferred to another company. In the second part, which will appear tomorrow, we take a close look at how the legal system would likely treat a DTC genomics company’s bankruptcy. In the final part, on Wednesday, we attempt to answer the only question that really matters for most readers: what does it all mean for the average DTC genomics customer?

Part I: The Fine Print: What the Privacy Policies Say

Privacy policies are particularly important in the field of DTC genomics where the sensitivity of consumer data is rivaled only by that found in other areas of healthcare and in the financial services sector. Courts and regulators are concerned as well. For instance, the Federal Trade Commission (FTC) has brought actions to enforce “companies’ privacy promises about how they collect, use and secure consumers’ personal information.” The first question, then, is how DTC genomics companies’ Privacy Policies address the possibility of selling customers’ data. As examples, we will consider the policies of two companies, TruGenetics and 23andMe, which, together, help to illustrate the range of policies in place today.

1. TruGenetics. Despite its funding difficulties and the fact that it has invited registrants to remove themselves from its database, TruGenetics does still maintain a website that provides both a Privacy Policy and a Terms of Use. The Privacy Policy (which is incorporated verbatim into the Terms of Use) focuses on data anonymization, transfers requested by registrants and GINA. As for how TruGenetics intends to use registrants’ genomic and other information, the only guidance comes from the Terms of Use, which include the following:

Your questionnaire responses and genetic information will be used for genetic research. One of the main goals of TruGenetics™ is to develop a unique research database for conducting genetic studies. Your decision to use TruGenetics’™ services indicates that you are willing to contribute your questionnaire responses and genetic information to the TruGenetics™ research database. . . . TruGenetics™ may conduct this research, or may partner with another organization, including non-profit and commercial entities, to conduct research. TruGenetics™ may charge a fee for conducting research using this database.

TruGenetic’s policy contains a promise of confidentiality and anonymity—although, as we have written elsewhere, that is a promise that is probably unwarranted—but there is no promise that the data will not be distributed to third parties. In fact, just the opposite is true—the purpose of the data collection is for it to be used by third parties for research, and the policy provides no assurance that the data will not be used for any other reason. TruGenetics’ policy itself therefore is no obstacle to the sale of the data, and provides no detail for a registrant to determine the circumstances under which his or her data might be transferred, either in the ordinary course of business or bankruptcy.

2. 23andMe. 23andMe has three separate policies applicable to users of its DTC genomics service: a Privacy Statement, a Consent and Legal Agreement and a Terms of Service. These policies clearly contemplate that certain personal information, including both genotypic and phenotypic information, may be made available to “commercial and/or non-profit organizations that conduct scientific and/or medical research.” While the Privacy Policy provides that such information will not be made available without “explicit consent,” it is unclear from the terms alone whether this consent requirement is satisfied by the consumer’s signing the Consent and Legal Agreement (which is required prior to any genotyping) or whether separate consents must be sought prior to the disclosure.

23andMe’s Consent and Legal Agreement applies to the company’s “successors and assigns” (as does TruGenetics’), thus expressly contemplating that information may be transferred. Much more explicit, however, is a separate section of its Privacy Policy entitled “Business Transitions” which states candidly that, in the event of “a merger, acquisition by another company, or sale of all or a portion of its assets,… your personal information and non-personal information will likely be among the assets transferred.” Indeed, as 23andMe’s research efforts expand, that information might represent its most valuable asset.

23andMe agrees to provide advance notice via email and prominent notice on the website of such a transfer, as well as to “require an acquiring company or merger agreement to uphold the material terms of this privacy statement, including honoring requests for account deletion.” Notably, although in other situations involving the potential transfer of private data (for instance, for research purposes) 23andMe repeatedly emphasizes that consent will be required before third parties receive access to personal information, that requirement is absent from the “Business Transitions” provision. In addition, the requirement that an acquirer uphold the privacy statement applies only to the “material terms” of the privacy agreement—leaving open the question whether any particular provision of the privacy agreement is “material.”

3. deCODE Genetics. deCODE’s DTC offering, deCODEme, has a Privacy Policy, a Service Agreement and a Terms of Use. These policies are conceptually similar to the 23andMe policies, appearing to permit the sale or transfer of genomic information provided that the terms of the Privacy Policy are generally upheld by the acquirer. While deCODE’s public financial difficulties were in some respects the impetus for this article, its unique legal situation as an Icelandic company doing business in Reykjavik, subject to a distinctive set of bankruptcy laws and statutory restrictions, renders it unrepresentative of other DTC companies. For that reason, we will continue to restrict our analysis to U.S.-based firms. A recent article in the journal Science, however, contains interesting speculation about what might happen to deCODE’s enormous customer biobanks, which is estimated to cover approximately 140,000 individuals, if the company does collapse, including speculation as to how deCODE might transfer its data to another EU entity under Icelandic and EU regulation.

4. So What Does It All Mean? If the company’s policy clearly permits the sale of genomic information in the kind of transaction that could be consummated in a bankruptcy case, then such a sale can go forward. But if the policy prohibits such a sale, or if the policy is unclear or does not address the subject at all, a transfer may still take place—subject to the ins and outs of bankruptcy law, including provisions specifically applicable to personal information. We’ll turn to that in the second part of this series.

Part II: Privacy Policies Through the Looking Glass of Bankruptcy Law

In part one, we discussed the importance of Privacy Policies and other legal agreements in determining how DTC genomics companies will treat their customers’ information, including in the case of a bankruptcy sale. Unfortunately, but not surprisingly, we failed to find much in the way of concrete answers. In this part, we investigate how a bankruptcy court would be likely to evaluate the proposed sale of a company’s genomic database, including in what scenarios it might be willing to set aside the company’s own agreed upon Privacy Policies.

1. Section 363 and the Stalking Horse. Section 363 of the Bankruptcy Code authorizes the sale (typically in an auction) of the assets of a business in bankruptcy. Quick auctions under Section 363 are becoming increasingly common because they allow for the transfer of desirable assets free and clear of liens and other liabilities (while leaving undesirable assets out of the deal), and unlike traditional Chapter 11 reorganizations, do not require the longer and more expensive confirmation process designed to fully protect the rights of creditors. During the current economic crisis, Section 363 was used in the sale of Lehman Brothers to Barclays Capital, in the sale of Chrysler’s valuable assets to Fiat and of General Motors to a new company backed by the U.S. Treasury. Section 363 auctions can also be lightning fast—Lehman Brothers’ assets, which were valued at billions of dollars, were sold less than a week after its Chapter 11 filing—although 2 to 3 months is more common.

In a Section 363 transaction, the bankrupt company agrees in principle to sell its assets to a “stalking horse” buyer, and then, following bankruptcy court approval of the sale procedures, solicits bids in an attempt to solicit a more favorable purchase price. The stalking horse company is often not outbid and winds up acquiring the most valuable assets. As the G.M. example demonstrates, there is no requirement that the stalking horse be a private company. Just as The Wellcome Trust has been mentioned as a potential acquirer of some of deCODE Genetics’ genomic database, a Federal agency such as the FDA or NIH could conceivably organize a bid for genomic assets it deemed important, assuming that it could muster the political and financial capital to proceed at the breakneck pace that can be required of Section 363 bankruptcy proceedings.

In response to a 2005 bankruptcy case (In re Toysmart.com LLC) in which a bankrupt toy company attempted to sell private customer data to its creditors in clear contravention of its own privacy policy, a new procedure was added to Section 363. The procedure requires the appointment of a Consumer Privacy Ombudsman (CPO) prior to the sale or lease of “personally identifiable information” from a bankrupt company when the proposed sale would be inconsistent with a company’s present and disclosed policy “prohibiting the transfer of personally identifiable information about individuals to persons that are not affiliated with” the company.

2. How To Know If You’ll Need a CPO. By law, the CPO procedure only applies when the proposed sale would be inconsistent with a company’s present and disclosed policy “prohibiting the transfer of personally identifiable information about individuals to persons that are not affiliated with” the company. However, bankruptcy courts have also appointed a CPO to advise them on the transfer of the information when the bankrupt company’s policy (like TruGenetics’) does not discuss whether the data may be sold to another company.¹ Thus, if a DTC genomics company employs a policy that permits the transfer of information and other assets to third parties, the CPO procedure will not apply.

If the company’s policies prohibit such a transfer or, as in the case of most DTC genomics companies, if they are unclear, the CPO procedure may be available to assist the bankruptcy court in evaluating the appropriateness of the proposed sale of “personally identifiable information.” But is genomic information “personally identifiable information”?

In order to qualify as “personally identifiable information” or PII, the information in question must satisfy two criteria. First, it must be “provided by an individual to the debtor in connection with obtaining a product or a service from the debtor primarily for personal, family, or household purposes.” Data submitted to a private genomics company for personal use (whether clinical or otherwise) would therefore qualify; data submitted for research purposes (which would arguably apply to the TruGenetics model, and possibly to certain services offered by 23andMe) would not satisfy this criteria.

Moreover, PII must contain, as at least part of the overall information content, one of the following specific pieces of information:

♦   Name
♦   Street Address
♦   Email Address
♦   Telephone Number; or
♦   Credit card number

As for something as seemingly personal as, say, a whole genome sequence, or perhaps just a record of 500,000 SNPs? That information, along with “any other information concerning an identified individual that, if disclosed, will result in contacting or identifying such individual physically or electronically,” constitutes PII if and only if it is “identified with 1 or more of the items of information” in the list above. Thus, while genomic information coupled directly with a name or other specified individual information would qualify as PII, de-identified genomic information, regardless of the practical possibility of later re-identification, would not qualify as PII and would not invoke the protections of the CPO procedure. It is unclear whether or not genomic information that was de-identified but capable of being re-identified through, for instance, coded identifiers, would be treated as PII.

Assuming that the presence of PII could be established, recall that the CPO procedure is only available when the proposed transfer would violate the company’s applicable privacy policy. In the case of 23andMe, for example, its privacy policy permits transfers to an acquirer but requires that the acquiring entity agree to the “material terms” of its existing privacy policy. If the agreement with the stalking horse did not mandate agreement to all the terms of the privacy policy—for example, if it declined to agree that the data could be deleted upon request in order to avoid the possibility that a significant number of spooked former customers of 23andMe would demand that their information be removed from the database—the court would then have to determine whether such a provision was material in order to determine whether the proposed transfer violated the privacy policy, a process in which it would be likely to seek input from a CPO (although it could order changes in the asset purchase agreement on its own). Thus, as a practical matter, the CPO procedure is likely to be available in order to evaluating ambiguous DTC genomics privacy policies.

3. What Does the “C” in CPO Stand For, Again? Even if a CPO is appointed, it is the bankruptcy court that must ultimately evaluate and approve the proposed sale of assets. The role of the CPO, if appointed, is to provide information to the court, including with respect to the following:

♦   the debtor’s privacy policy;
♦   the potential losses or gains of privacy to consumers if such sale or such lease is approved by the court;
♦   the potential costs or benefits to consumers if such sale or such lease is approved by the court; and
♦   the potential alternatives that would mitigate potential privacy losses or potential costs to consumers.

Keep in mind that the bankruptcy statute does not require the CPO to represent the interests of the consumers. In fact, “the Consumer Privacy Ombudsman appears more in the role of an expert commentator than a consumer advocate.”²  Also, recall the speed at which auctions under Section 363 are conducted. Given the logistics and time entailed in first determining whether a CPO is warranted and, if so, locating and appointing a CPO, the CPO in most instances can be expected to have “only a day or two to obtain the information he or she needs and digest it.”³  With privacy issues as complex as those that would be presented in a DTC genomics company’s bankruptcy, and in the absence of any guarantee the CPO will be someone familiar with the issues, there is scant hope of a sophisticated analysis.

A review of the cases in which a CPO has been appointed and filed a report reveals a clear pattern: the CPO supports the sale “provided certain conditions were met, such as requiring that (1) the sales be made to qualified purchasers (those in the same business or that would operate the same business as the debtor), (2) the purchaser would serve as a successor-in-interest to the debtor’s … privacy policies and (3) customers be provided an opportunity to opt-in or opt-out of the proposed transfer.”⁴ It appears to be highly unlikely that a CPO would recommend a transfer in which the buyer would not agree, going forward, to abide by the same privacy policy that governed the data prior to the transaction.

So bankruptcy law clearly sees the possibility that genomic data could be sold in violation of its privacy policy—since that is the situation that would trigger review by a CPO. But as we just noted, the actual cases in which CPO’s have conducted such review indicates that, while a bankruptcy court may override a provision in a privacy policy that prohibits the transfer of data to a third party, the CPOs and courts do seem to be unwilling to override other provisions, but rather wish to make sure that the policy is otherwise enforced by the acquirer, and not used for any markedly different purpose than before.

4. The FTC and Other Considerations. Of course, even if the CPO were to recommend a transaction in which the data would no longer be subject to the same kind of restrictions present in the privacy policy when the data was gathered, the CPO’s report is not binding on the court. Furthermore, in such a case—or in a case in which a CPO was not appointed because the information transferred did not qualify as PII—the FTC and state attorneys general could well decide to intervene. As the FTC website states:

A key part of the Commission’s privacy program is making sure companies keep the promises they make to consumers about privacy, including the precautions they take to secure consumers’ personal information. … Using its authority under Section 5 of the FTC Act, which prohibits unfair or deceptive practices, the Commission has brought a number of cases to enforce the promises in privacy statements, including promises about the security of consumers’ personal information.

However, because of the speed at which the typical Section 363 auction takes place, combined with the limited resources of the FTC, it cannot be assumed that the agency (or one or more state attorneys general) will get involved in every case in which private data will be transferred without appropriate authorization in a privacy policy. The field of DTC genomics is sufficiently prominent, however, that it seems unlikely that the FTC would fail to receive notice and, if necessary, review any proposed transfer that raised significant consumer privacy concerns.

So what does this all mean for the average DTC genomics customer? Tune in tomorrow when we attempt to put all the pieces together.

Part III: What Does It All Mean?

In part one, we discussed the importance of Privacy Policies and other legal agreements in determining how DTC genomics companies will treat their customers’ information, including in the case of a bankruptcy sale. Unfortunately, but not surprisingly, we failed to find much in the way of concrete answers. In part two, we dug into the law to investigate how a bankruptcy court would be likely to evaluate the proposed sale of a company’s genomic database, including in what scenarios it might be willing to set aside the company’s own agreed upon Privacy Policies. In this final part, the threads come together as we ask—and attempt to answer—the only question that really matters for most readers: what does it all mean for the average DTC genomics customer?

If you’re concerned that your DTC genomics provider of choice might be a candidate for bankruptcy the very first thing to do, of course, is to consider whether the privacy of your genomic data is even important to you. If you’re applying for (or already enrolled in) the Personal Genome Project, for example, chances are that you wouldn’t much care if 23andMe went bankrupt and decided to sell your information to a competitor, to a pharmaceutical company or to anybody else.

But for the many customers who, at least at present, consider the privacy and security of their genomic data to be an important factor in choosing whether to purchase the services offered by DTC genomic companies, there is simply no substitute for reading to the bottom of the page. When you purchase a product and utilize the corresponding services, including the website where you view your genomic information, you are agreeing to the terms supplied by that company.

As for what those terms say, while it varies on a case-by-case basis and the terms are always subject to change (and they do, in fact, change, often in response to developments in either the law, the company’s business model or both), the prediction here is that if your DTC genomic company of choice goes belly up there is a good chance that its assets, including its database of genomic information, will be up for sale.

The good news is that, in all likelihood, the sale would be restricted to another company that would use the data for substantially the same purposes as the original company and generally agree to abide by the same privacy protections as the now-bankrupt company. Again, those provisions vary by company but generally provide individuals with an ability to terminate their involvement with the company and withdraw their information (to the extent that it has not already been made available to third parties for allowable research or other purposes) from the company’s database.

Finally, as with just about every aspect of genomics law, the most complete and accurate answer is that time will tell. When the first DTC genomics bankruptcy inevitably arrives it will help answer more definitively a host of important questions, including whether and how a government agency might take an interest in commercially acquired genomic data, whether genomic data will be considered personally identifiably information under bankruptcy law and how debtors, creditors, consumers and regulators will react to the sale of large-scale genomic databases.

———————

¹ Luis Salazar, Don’t Fear the Consumer Privacy Ombudsman, 26 American Bankruptcy Institute Journal 42 (2007).

² Warren Agin, Handling Customer Data in Bankruptcy Mergers and Acquisitions-Coping with the Consumer Privacy Ombudsman Provisions of the 2005 Bankruptcy Act, E-Commerce Issues and Developments

³ Agin.

⁴ Salazer.

One of the first questions on everyone’s mind, particularly in light of the high-profile lawsuit by the ACLU and others against Myriad Genetics, is whether this newly discovered Alzheimer’s gene could be patented. In principle, yes.  Going back at least to the early 1980s, the U.S. Patent and Trademark Office (US PTO) and the federal courts have repeatedly taken the position that genes in isolation from their natural environment (that is, outside the body) are patentable subject matter, just like any other chemical compound. Individual cases have turned on such specifics as whether others had previously identified the gene, or whether and when the patent applicant or others had first disclosed the gene. But there is no general prohibition against patenting genes.

On the contrary, a recent draft report on gene patenting (pdf) prepared for the Secretary of Health and Human Services by the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) estimates that about 20% of human genes are covered by patents, including such controversial examples as BRCA-1 and 2, which are linked to susceptibility to breast and ovarian cancer and are the subject of the ACLU’s suit against Myriad Genetics.

What is the practical significance of patenting a gene sequence? A patent allows the holder to prevent others from making, using, or selling the patented invention for twenty years. There is no meaningful research exception, nor any obligation to permit any particular use. To do research on a patented gene outside the body, or to perform a genetic test, is to use the patented invention—and that requires the permission of the patent holder. So researchers who want to study the genes, or doctors who want to have their patients tested to determine which versions, or alleles, of a patented gene they possess, must first seek permission, usually at some financial cost.

If Duke or a spinoff were to patent TOMM40 and/or APOE, the outcome could be the same: the patent holder would control access to the gene for both research and diagnostic testing, and be permitted to set whatever price the market (in most cases, insurance companies) would bear. (This is, of course, illustrative only: there is no indication that Duke is or has any intention of pursuing such a strategy.)

There are all kinds of horror stories surrounding gene patents, including claims that they stifle important research and commercial innovation, or that they result in the denial of essential medical tests to the poor and uninsured. (Last week Dan Vorhaus and I discussed the effects of gene patents on the emerging whole-genome sequencing industry.) The most frequently cited concern is the case of the BRCA-1 and 2 alleles, the patent rights to which are owned by Myriad Genetics, a University of Utah spinoff. (Myriad also has obtained patents on a variety of related diagnostic and testing methods, which is a common practice among gene patent holders.) As the patent rights holder, Myriad can choose whether, and on what terms, to permit research, and it performs (or licenses others to perform) the majority of the BRCA-1 and 2 genetic tests itself for fees that the SACGHS report calls “midrange.” Myriad’s gene patents are the subject of a recent and highly publicized lawsuit brought by the ACLU alleging that the patents are both illegal and unconstitutional.

But how accurate are these claims? The SACGHS report reviews the range of studies on the effects of gene patents and reaches no firm conclusion. There are reports of problems in conducting research, and tests on patented genes are sometimes more expensive that they might be otherwise, but in the aggregate the evidence seems equivocal. As the SACGHS report puts it:

Based on its review of the literature, case studies, and review of international policies regarding gene patents, SACGHS found little in the way of broad or consistent evidence that indicates either positive or negative effects of gene patents on patient access to diagnostic tests.

Regardless of effects, gene patent proponents retort that the promise of a patent monopoly is essential to lure private capital and motivate researchers. This claim, however, is particularly hard to test, since we’ve never tried it any other way.

A final thought concerns the future of gene patents. I suggested in my previous post on the ACLU-Myriad litigation that the ACLU’s frontal attack on genes as patentable subject matter was a long shot at best. But I also noted a number of other cases that seemed to be chipping away at the margins of gene patents by finding them obvious or inadequately described. The Supreme Court has also decided to review a business method patent case from the Federal Circuit, In re Bilski (pdf), that may have implications for patents on diagnostic techniques. So gene patents would appear to be here to stay, but the impact of gene patents on both research and commercialization is still very much up in the air.