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News and analysis from the intersection of genomics, personalized medicine and the law
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Dan Vorhaus advises genomics and biotechnology researchers, entrepreneurs, companies and investors on legal compliance and commercialization strategies. Bio |
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May we have a discussion about DTC genomics and telecommunications. When genomic data will arrive on our portable devices, how much telecom companies will be implicated, what about data safety (our genome represents merely 2Go of data)…etc
If an individual undergoes a whole genome sequence analysis, will they ( or the sequence company) have to pay royalties to Myriad because the BRCA1/2 loci will have been sequenced ?
Henry: excellent question. John Conley and I have published a new piece tackling that very topic: http://www.genomicslawreport.com/index.php/2009/08/11/whole-genome-sequencing-and-gene-patents-coexist-for-now/
There has been a lot of hype about consumer sequencing.
Is there any advantage of getting genomes sequenced (from the point of view of the consumer ) specially when the data analysis segment of this market is in its infancy . In short why would some one want to get their genome sequenced atleast in the next few years, when there is very less useful info you can get out of it .
Sequencing the genome is fine, but what do you do with the data to make it informative? One approach involves the creation of high and low risk gene variant sets, e.g. using grade-of-membership analysis, and relating individuals to these sets in order to define risk for various disorders/ traits. This network-like approach defines a wide range of risk, and is stable, based on biochemistry.
Has anyone yet looked at the ability of different DTC genomic labs to get the same results on a shared sample? Lab-to-lab variability has plagued even routine clinical laboratories doing rather routine assays. Can such a complex task as sequencing be duplicated by different laboratories?
It would be most interesting if you could write an article on the ownership of DNA samples. Some testing companies store DNA samples whereas others destroy the samples once they have the results. In some cases, for family history purposes a female relative might sponsor a DNA test for a male relative or a project administrator might raise funds to sponsor a test for a targeted candidate. Does the fact that someone has paid for a DNA test give them any “ownership” of the sample and the ensuing results? With companies such as Family Tree DNA, Ancestry and DNA Heritage people can join surname projects, haplogroup projects and geographical projects. They are then entrusting their sample and their results to their project manager. What happens if the testee dies? Do the surviving relatives assume ownership of the sample? Does the project admin assume responsibility? Is the admin able to order extra tests on that sample after the decease of the participant or is he expected to get consent from relatives? What happens if two children disagree on how their parents’ DNA should be used? Who owns the results that are generated from a DNA sample?
There are different laws in different countries. In the UK for instance it is illegal to “steal” someone’s DNA without consent but this situation does not apply in America. If a UK resident is on holiday in America and someone “steals” his DNA and has it tested in America does that person have any control over his DNA sample or does the “thief” own the sample?
Your thoughts on these matters would be much appreciated.
Now that Paragon Dx has been told to go the PMA route for warfarin sensitivity testing, does this mean that all genetic testing of this type needs to follow that pathway? There’s a lot of pre-warfarin testing going on. FDA decided that Paragon Dx’s ASR were not ASRs.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm207375.htm
Would appreciate your thoughts on this.
Are there any good books published on this subject? I would very much like to read up on this interesting and developing area.
Here in Naples Fl, our Collier County Commission is going to put up 130 million to finance a ‘cluster’
of research companies, including Jackson Labs and Atheleticode along with local University research departments.
Many residents think it is a scam to benefit the large landowners, as this cluster is to be located some 30 miles from Naples in the Everglades watershed.
To date there has been no investigation of this idea and the motives behind it.
A report by your organization would be helpful.
Thank you
Robert Divale
Naples, Fl
239-272-9179
rdivale@comcast.net