A Fundamental Right to Genetic Information (Now More Expensive Than Before)
This is the second 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, The Open Secret of DTC Medical Genetic Testing and DTC Genomic Research: Revolution or Minor Uprising?
An Unexpected Increase in Price. In considering 23andMe’s new model from the consumer perspective, the most surprising development is that the announcement comes with a price increase. With the steady drumbeat of stories heralding the approach of the $1,000 genome, and the consumer expectation that prices for established technologies are meant to fall, not rise, the price hike was unexpected.
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The Open Secret of DTC Medical Genetic Testing
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.
DTC Genomic Research: Revolution or Minor Uprising?
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:
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Weekly Twitter Roundup
Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:
- The future of personal genomics? http://bit.ly/4dYwB4 @Knome-20 years “Every medicine you take will be tailored specifically to your genome”
- Pathway Genomics Sets Discount Deal with OptumHealth Allies http://bit.ly/2R2G84 (via @gw_dailyscan)
- Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics http://bit.ly/RkUhy (via @NEJM)
- Genomic Research Continues To Go DTC: http://bit.ly/vCNSe
- “So…One Can Have Their Complete Genome Sequenced…Should I?” http://bit.ly/4wbh1i (from Patrice Milos of Helicos)
- RT @dgmacarthur: Sequencing powerhouse in the East – Bio-IT World profiles the Beijing Genomics Institute: http://bit.ly/3tUkRl
- A good example of how the “DNA mystique” infects media reporting on genetics/genomics: http://bit.ly/CTdBc
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Genomic Research Continues To Go DTC
Way back in July I wrote about an emerging dimension in the DTC genomics space: direct-to-consumer genomic research. That article focused on the activities of 23andMe, and TruGenetics, which made a summertime splash by offering free genome scans to the first 10,000 individuals willing to contribute their genomic information to a commercial research database. While TruGenetics has since faltered, 23andMe continues to push DTC research forward.
Last month, at the American Society of Human Genetics (ASHG) meeting, 23andMe presented some of the first preliminary DTC research results. Daniel MacArthur of Genetic Future discussed 23andMe’s findings (emphasis in original):
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“So… One Can Have Their Complete Genome Sequenced…Should I?”
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Patrice M. Milos, Helicos BioSciences Corporation.
I’ve had a fascinating time reading these posts and it has taken me awhile to articulate a question I imagine many of you might, or will, have. I believe the above question will be front and foremost on people’s minds in the next two to three years. As genome sequencing costs continue to fall dramatically, we will arrive at our end goal of the $1000 genome… or perhaps even $100… shortly.
Yet it is just this one question which raises many more ELSI questions.
First and foremost – do I have a right to my genome sequence?
I have a fundamental belief that the answer is a resounding yes. Why should I have to worry about whether I can obtain the sequence of genes that may actually prove important for key decisions for me as well as my family?
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Provisional Patents: A (Temporary) First Step
Any entrepreneur is likely to be euphoric when her company discovers a novel and potentially valuable genomic invention that may be protectable by a patent. But when the celebrations start to fade, difficult decisions will remain about how to protect and exploit the intellectual property rights associated with the invention. A company may protect its rights by carefully avoiding disclosure until it has reduced its invention to practice (that is, made it work) and filed a patent application. But our entrepreneur may not have that option. Reducing the invention to practice requires money, which may be in short supply.
For the purpose of this post, we assume that the entrepreneur has already taken the required steps to be sure the company owns all necessary rights in the invention. (See our earlier Bench to Market articles: “What Happens When Professors Have Valuable Inventions?” and “Don’t Overlook Agreements with the Inventors.”) How can she now have the discussions with outside parties (such as venture capital firms) that may be necessary to commercialize the invention, without risking the loss of important intellectual property rights?
To the moon: In support of the genomic astronauts who will take us there.
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jason Bobe, Personal Genome Project.
At the frontiers of science and engineering, promising new technologies are becoming available that will help us address pressing problems in human health and well-being. As the recent history of personal computing has shown, technology is often the easy part. Once into the world, technologies tend to go careening down the well-beaten path toward “better, faster, and cheaper” on a journey that leads ultimately to everyone’s front door. Personal genomic technologies are no different. If you don’t have any DNA sequence of your own yet, you will soon and so will many of your family, friends, and neighbors (and pets too).
Making personal genomes useful is a much more formidable challenge. In medicine, we want to employ personal genomics in the development of therapies that eliminate disease and diagnostics that reduce illness through early detection or prevention. In our personal and family affairs, we want knowledge that enables us to lead fuller lives, to know how our own personal biology interacts with the varied environments and lifestyle choices that makes us who we are and connects us with others.
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Bilski and Biotechnology: The Supremes Speak Up
The Supreme Court heard oral argument in the Bilski case yesterday (pdf of full transcript). The Justices’ questions evinced unmitigated hostility to Bilski’s claim on a method of hedging commodities risks, and to business method patents generally. Detailed analysis of the oral argument is available from ScotusBlog, Patent Docs and Blawg IT. The decision in Bilski will have far-reaching consequences for patents on methods of analysis, data interpretation, and performing certain tasks, and at the GLR we have several times noted the potential significance of the case for biotechnology patent law.
The Justices may not be reading the GLR (or are they?), but they are well aware of Bilksi’s potential implications. In argument, Justice Sotomayor commented that if the Court upheld the Federal Circuit’s Bilski decision she would “have no idea what the limits of that ruling will impose in the computer world, in the biomedical,” but expressed concern that upholding Bilski’s machine or transformation test could “destroy industries” by “shoe-horning technologies that might be different.” And Justice Ginsburg, while remarking that Bilski “could be decided without making any bold steps,” conceded that “we know that things that we haven’t yet contemplated may be around the corner, and when they happen, we will deal with them.”
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Disclosure of Patients’ Genetic Information Without Their Consent–Is the “Public Interest” Really a Sufficient Justification?
New guidance issued by the U.K. General Medical Council (GMC) regarding a physician’s ability to disclose to a patient’s relatives the diagnosis of such patient’s genetic illness1 has recently been a hot topic of discussion on several online forums.2 The guidance, which became effective on October 12, 2009 and addresses medical privacy issues in a variety of contexts (not just genetic information sharing), recognizes that the diagnosis of a patient’s genetic illness may indicate the likelihood of the same illness in the patient’s close blood relatives. The GMC suggests that a physician’s first obligation after diagnosing a genetic illness is to explain to the patient the likelihood that close relatives are also at risk and to encourage the patient to discuss his or her illness with relatives. However, should the patient refuse to voluntarily disclose the illness to at risk family members, the physician may disclose such information if disclosure would be “justified in the public interest.” Physicians are instructed to balance their duty to provide care to the patient against their duty to protect others from serious harm.3
