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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.
@Ron: as a matter of fact, there are. Two of the best are:
“Here is a Human Being At the Dawn of Personal Genomics” by Misha Angrist
“The $1,000 Genome: The Revolution in DNA Sequencing and the New Era of Personalized Medicine” by Kevin Davies
@Kathleen: 8 months later, we are still little closer to knowing what the FDA’s regulatory roadmap will look like. The plan is clearly to bring LDTs more in line with IVD kits, and that would include PGx tests, but the waiting on details will continue until at least 2011.
@Debbie: It took a while, but we tackled this topic in a recent post on surreptitious genetic testing. If you are still looking for more information, Professor Joh’s law review article (which is discussed in the comments) is an excellent source.
@Teresa: An excellent question. This is an ongoing topic of conversation here and elsewhere. For an update on many of these issues, please see this recent post.
I would like an article entitled “PacBio, Don’t Believe the Hype.” After reading many sequencing technology reviews and the new cholerae paper published January 11th, I question PacBio’s SMRT technology. The paper does not mention the raw error rate nor the cost of sequencing.
Dr. Elemento took the liberty of aligning raw PacBio reads to the V. cholerae reference genome.
http://oelemento.wordpress.com/2011/01/03/a-closer-look-at-the-first-pacbio-sequence-dataset/
He concluded that the raw error rate is a whopping 20%. With a throughput of only 5.3Mb/30 minute run, the instrument is less than impressive. In comparison, the 454 FLX genome sequencer has a throughput of 6.67mb/30 minutes with 99.5% raw accuracy. PacBio’s prototype offers 950bp average reads. The 454 FLX offers 250bp reads. 454 plans to offer 1000bp reads in its next instrument. Reads are especially important in de novo assembly, but PacBio’s massive raw error rate prevents its use for de novo sequencing. There is a trade off between throughput and raw error rates that PacBio may not be able to overcome. The instrument does not even have high throughput to trade! The instruments have similar initial costs of ~$500,000. At such a high error rate researchers would have to sequence more, I don’t care how long the read is, increasing sequencing time far beyond that of 454 instruments. PacBio is trying to overcome technical challenges, but I just do not see a marketable instrument emerging by the end of the year. 700mil market cap is ridiculous. There is not market for the current instrument. We will see PacBio hemorrhage cashola for ~6 months and watch its market cap slowly fall unless magical innovations break through the darkness that veils the almighty biotech god.
I have thought a lot about is claim scope (whether the claims can be interpreted in their ordinary usage or just the examples of embodiments in the patent). I have written about that topic (http://trentostler.com/blog/patent-claims-scope/), but I was curious about comparing this topic across different foreign patent systems. Which jurisdictions restrict the patent claim to only what is exemplified in the patent and which jurisdictions allow for the claim language to dictate the subject matter of the invention.
Looks like my prediction above has come true. Now it is time to evaluate Gen-Probe, one of Pac-Bio’s early investors. They just solicited themselves publicly. A “For Sale” sign looms over Gen-Probe.
Now the big question….why?
The executives must have been soliciting the company privately for years. To put it simply, they do not see any avenues for growth. They want to cash out. With the failed Pac-Bio investment and no avenues of expansion into the sequencing market, Gen-Probe’s growth appears stalled. Do they have the talent to expand into other markets? Molecular diagnostics is a cash cow for them.
Who would want to buy Gen-Probe with no expansion methods in sight? The investing company would have to regain their investment over time with the positive cash flow from the molecular diagnostics business. Yet, no private takers. Seems desperate-executives want to cash out. Do they not have the talent to expand into or create new markets?
Will a financial person please do the profitability analysis for me so I can tell if it makes sense for some of these big name buyers to bite. Then I can short or buy. Thanks-hit me up. jbmimms@gmail.com
Dan,
It’s time to talk about life technologies grand challenges.
http://www.lifetechnologies.com/content/lifetech/en/home/about-life-technologies/grand-challenges.html
What is this shit?
People are idiots if they enter this. If you really solved these issues you should patent the shit out of your ideas and license them for way more than they are asking. New algorithms and prep techniques could be applied to any sequencer and you could just start a bidding war for your patent. Life technologies is scrambling for new ideas and is trying to steal them from academics.
Please,
Address this before some smart people give away their best ideas for pennies.
Are Vermont’s genome data mining laws constitutional? The Supreme Court has decided to take this case on. What are the merits and implications?
I told you man. Pacbio don’t believe the hype was a great article. Why didn’t you wrote it? Also the genprobe 80-70 fall confirmed my suspicions. Hope you made some money.
Dear friends, I would like to receive an explanation about “license in” and “license out”, once I am now assuming a new challenge as new business manager in a pharmaceutical company in Brasil. Regards, Sergio Perelman
Dan,
We need an article:
Where did all the phenotypic information go? Does Coriell have it? Who is collecting it? Why are we not sequencing people at hospitals with volunteer-able medical information for these sequencing projects? What is proprietary and what is not? Get your investigative reporter motors in gear, its show time.
We need an article on replacing shitty PSA screening.
Right now PSA is a 100 million dollar market – with a better test, this market will expand.
One of Gen-Probe’s programs produced a product meant to improve PSA.
Instead of making the $50 million investment needed to run a clinical trial for a stand-alone PSA replacement, G-Pro decided to couple their product with PSA so they would not have to get additional approval from the FDA. With the money they stupidly invested in PacBio, they could have cornered and expanded the prostate screening market.
Progensa should have been designed as a screening test from the beginning.
Hindsight is always 20/20, but when you have competent people predicting the course of events and instead listen to suggestible, superficial. hype-susceptible individuals, you are heading for disaster.
This should serve as an anecdote at B-schools.
Ah yes, to get those phenotypes:
http://www.genomeweb.com//node/983548?hq_e=el&hq_m=1131185&hq_l=1&hq_v=131bd3495f
Always one step ahead.
Let’s see an article about this – NUgene on steroids. What legal and ethical concerns do these programs raise?
And when I get my hands on that sweet phenotypic data…you can be damn sure I have an innovative way to optimize interpreting the full human genome.
Hi! This is my 1st comment here so I just wanted to give a quick shout out and tell you I genuinely enjoy reading through your blog posts. Can you suggest any other blogs/websites/forums that go over the same subjects? Appreciate it!
What is the best doable way of obtaining protected from third party law suits?
You may want to follow up on this emerging topic taking place at 23andMe.
Note there are additional links in this blog.
http://blog.eogn.com/eastmans_online_genealogy/2012/01/23andme-generates-controversy-with-new-subscription-policy.html
I love what you guys tend to be up too. This sort of clever work and exposure! Keep up the awesome works guys I’ve you guys to my blogroll.
It would be of great benefit to employers, to see more discussion regarding the “Water Cooler” issue. Specifically, what is considered a Water Cooler disclosure. Does it have to be public? Could that exemption be applied where the employee requests an Accommodation be made, due to a health condition, the disclosure of which imparts Genetic Information.
He makes this written e-request, through the HR portal, which is forwarded electronically, directly to the health professional working at his facility. Company Health professional takes steps necessary to consider the request, including assessment of job duties, requiring certification from employee’s physician, assessment of the work environment, etc…
Upon reaching a decision, an appointment is made wherein the Health Professional, Manager and Employee have a private conversation, to discuss the final outcome of the Accommodation Request.
Would a disclosure made in this formal documented meeting, be considered subject to the Water Cooler exemption?
Thanks.