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Old 12-05-2013, 07:42 PM   #21
gringer
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So, they're still doing the same things internally, still selling the kits, still letting people download them, still letting people see their association results if they purchased prior to the FDA anger, and still letting people do the ancestry stuff. The only thing that has changed is that 23AndMe will no longer provide a web service for new tests that includes medical association analyses and disease prediction.

I envisage a bunch of start-up "analyse your 23AndMe data for less than the cost of a doctor's visit" websites (assuming they don't already exist) in the near future, shifting from a single website with a consistent analysis policy that is easy to regulate and standardise to multiple websites from different companies that all have different ideas about the most appropriate statistics for calculating probabilities.
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Old 12-05-2013, 07:53 PM   #22
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Promethease is an example of one of those services: https://promethease.com/ondemand

23andMe would have to convince users to go offsite for health analysis. Not sure if the general public would have interest anymore.

- Genohub
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Old 12-06-2013, 03:21 AM   #23
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Interesting. As I predicted in earlier post, they take out the health-related stuff for now. To my surprise, traits related stuff is also removed as well. I wonder how they can grow their business in the near term.

A sad day for consumers indeed.
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Old 12-06-2013, 03:23 AM   #24
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Originally Posted by gringer View Post
So, they're still doing the same things internally, still selling the kits, still letting people download them, still letting people see their association results if they purchased prior to the FDA anger, and still letting people do the ancestry stuff. The only thing that has changed is that 23AndMe will no longer provide a web service for new tests that includes medical association analyses and disease prediction.

I envisage a bunch of start-up "analyse your 23AndMe data for less than the cost of a doctor's visit" websites (assuming they don't already exist) in the near future, shifting from a single website with a consistent analysis policy that is easy to regulate and standardise to multiple websites from different companies that all have different ideas about the most appropriate statistics for calculating probabilities.
Well, I don't think anyone US-based will now dare to run such start-ups now.
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Old 12-06-2013, 03:30 AM   #25
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Originally Posted by Genohub View Post
Promethease is an example of one of those services: https://promethease.com/ondemand

23andMe would have to convince users to go offsite for health analysis. Not sure if the general public would have interest anymore.

- Genohub
Looks like they are Maryland based. I suppose FDA should also go after them for fairness' sake?
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Old 12-06-2013, 03:32 AM   #26
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Looks like they are Maryland based. I suppose FDA should also go after them for fairness' sake?
If they haven't done the needed validation and aren't presenting things in a meaningful way then I'd be happy to see them shuttered.
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Old 12-06-2013, 04:16 AM   #27
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Does 23andme have a competitor that provides a service that involves a physician? If there exists such a service, does that make that service a "Lab Developed Test" that is acceptable to FDA for now?

As a matter of fact, OncoType DX and Foundation Medicine are both LDTs.
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Old 12-06-2013, 06:07 AM   #28
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I guess the FDA will probably be pulling pregnancy tests next as "patients" may make irrational decisions based on the information without consulting a physician.

As suggested, a 3rd party could provide the search of NIH's gwascatalog.txt
No big. It's pretty easy to put some CGI/CSS/HTML5 + stock images on the following query ...

cat ~/gwascatalog.txt | cut -f8,15,21,22,28 | sort -k3gr | grep rs2075650
AB1-42 TOMM40 rs2075650-G rs2075650 3E-7
Age-related macular degeneration TOMM40 rs2075650-A rs2075650 1E-6
Age-related macular degeneration TOMM40 rs2075650-A rs2075650 8E-8
Alzheimer's disease biomarkers TOMM40 rs2075650-? rs2075650 1E-6
Alzheimer's disease (late onset) TOMM40 rs2075650-G rs2075650 5E-36
Alzheimer's disease TOMM40 rs2075650-G rs2075650 1E-295
Alzheimer's disease TOMM40 rs2075650-? rs2075650 2E-157
Alzheimer's disease TOMM40 rs2075650-? rs2075650 2E-16
Alzheimer's disease TOMM40 rs2075650-? rs2075650 3E-11
Brain imaging - rs2075650-? rs2075650 NS
Cardiovascular disease risk factors TOMM40 rs2075650-G rs2075650 2E-14
Cardiovascular disease risk factors TOMM40 rs2075650-G rs2075650 4E-8
Cholesterol, total TOMM40 rs2075650-G rs2075650 3E-19
Cognitive decline TOMM40 rs2075650-G rs2075650 2E-8
C-reactive protein TOMM40 rs2075650-? rs2075650 1E-7
Longevity TOMM40 rs2075650-? rs2075650 3E-17

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Old 12-06-2013, 07:39 AM   #29
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Right, because there's no difference between a test that advertises its percentage reliability on TV commercials and one for which the customer actually needs a relatively sophisticated understanding of statistics (multiple testing, relative risk, etc.) to not misinterpret.
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Old 12-06-2013, 08:12 AM   #30
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Does a customer need a relatively sophisticated understanding of the internal combustion engine to buy a car? Of the odds that he will die in crash? No.

Does the purchaser of any good or service require sophisticated knowledge of costs and benefits?

Can't someone who has the BRCA1 mutation decide "well, I need to start mammograms at age 30", or if they don't "well, I'll wait until later in life"?

More information is good. People taking personal charge of their health is a good thing.

Even if there's strong evidence that knowledge is bad, is it right to outlaw it?
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Old 12-06-2013, 08:40 AM   #31
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Does a customer need a relatively sophisticated understanding of the internal combustion engine to buy a car? Of the odds that he will die in crash? No.
The reason is the same as why you can't get all medications over the counter. I assume you were being facetious in not recognising your false analogy.

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Does the purchaser of any good or service require sophisticated knowledge of costs and benefits?
Yes, see most medical products.

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Can't someone who has the BRCA1 mutation decide "well, I need to start mammograms at age 30", or if they don't "well, I'll wait until later in life"?
You're assuming that the mutation is actually there. It's expected that there is [BOLD]at least[/BOLD] 1 medically meaningful false positive per run (Lior Pachter ran the numbers on his blog). Do you expect the average consumer to weigh that when seeing all of the findings?

Breast cancer is at least easy to subsequently screen for (though mammograms aren't without risk, see the recent reasons for the changes in screening), for many other clinically relevant changes this may not be the case. What do we expect people to do when told (possibly incorrectly!) that they're at increased risk for Alzheimer's or Parkinson's? There's no screen for those and the increased risk due to a random SNP is actually going to be quite small. Those will combine to yield some unfortunate results...

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More information is good. People taking personal charge of their health is a good thing.
While the latter is good, the former isn't always. If we invented a machine that could non-invasively screen every cell in the prostate for cancer we would have maximized the amount of available information available to the patient. We would also find that likely every adult male has prostate cancer, regardless of the fact that this would only become clinically relevant in a small percentage of cases. Information simply for information's sake isn't always good.

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Even if there's strong evidence that knowledge is bad, is it right to outlaw it?
Nothing is outlawed, it just has to be done correctly.
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Old 12-06-2013, 09:09 AM   #32
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Some fair points.

23&me remains liable for any fault in their product.

Market forces might better arbitrate quality of genetic testing than FDA mandate.

There's little evidence that costs outweigh the benefits at this point. Government intervention and regulation is premature in this case.
If people were harming themselves based on this information, they might have a case. Regardless, it's information, not a drug. Government trying to control information flow usually doesn't work out too well.

I'm not sure the general practitioner who got is M.D. in the 1980s, ( i.e., the guy who's going to deal with the questions when the consumer seek counsel), is going to have total grasp of "bonferoni adjusted chi-squared" whatever.
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Old 12-06-2013, 09:23 AM   #33
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Some fair points.

23&me remains liable for any fault in their product.

Market forces might better arbitrate quality of genetic testing than FDA mandate.
Rational market theory only holds when the market is rational, which I seriously doubt would be the case here :P

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There's little evidence that costs outweigh the benefits at this point. Government intervention and regulation is premature in this case.
If people were harming themselves based on this information, they might have a case.
It's partly the FDA's job to avoid harm, not just attend to it after the fact. Also, part of the point of the FDA's complaint was that 23&Me hasn't done enough to demonstrate an actual gain. Granted, much of that is just providing the consumer with the results in a digestible (yet not misleading!) fashion, but there also seems to be more (at least from reading a few different blogs/articles that seem to have a broader knowledge of the reasons than those simply presented in the warning letter).

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Regardless, it's information, not a drug. Government trying to control information flow usually doesn't work out too well.
It's a diagnostic test, not just harmless information.

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I'm not sure the general practitioner who got is M.D. in the 1980s, ( i.e., the guy who's going to deal with the questions when the consumer seek counsel), is going to have total grasp of "bonferoni adjusted chi-squared" whatever.
No disagreement there. There would need to be a clinical geneticist involved in the process (see also the analogous discussion over on Biostars).
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Old 12-06-2013, 09:57 AM   #34
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Obviously we're going to disagree on this issue.

I think the consumer is rational. Government intervention, in this case, is "protecting" somebody. But it's probably not the consumer.
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Old 12-06-2013, 04:05 PM   #35
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Why do 23andme also pulled their non-medical traits tests? Are those under FDA jurisdiction?
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Old 12-07-2013, 03:27 AM   #36
gringer
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It'll be much easier to pull everything from the backend than to selectively remove specific traits. Maybe sometime in the future they'll have a discussion with the FDA about what traits can be added in, modify the display algorithm, and slowly increase the visible traits.
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Old 12-09-2013, 10:30 AM   #37
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I recently had a physical with a round of blood/urine tests. All the data were stored on a secure web site I could access and browse with some guides as to what the numbers meant. If my doctor could put results of genetic tests there as well that would be good. I also wouldn't have a problem with going to a minute clinic type facility at a pharmacy to have the tests performed, why do the genetics tests need to be anymore accessible? I don't really see how requiring that the tests work, prevents me from interpreting the results. Furthermore, when it comes to genetic tests as a consumer, I am willing to tolerate zero wiggle room on the business diagnostics end. After all my health is about me not their business model. The concept that people want to allow Joe Random Plumber's market forces to regulate the genetics field is a little disconcerting, we've seem how well that works take insurance for example. A test with little regulation, would do nothing but mandate future confirmation tests. Why not, get the test right in the first place?
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Old 12-09-2013, 09:30 PM   #38
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Originally Posted by rskr View Post
Why not, get the test right in the first place?
This can cause the prices to go sky high. Think about the $100K per year cancer targeted therapy drug that you can have at $1K if it were Indian generics.

It will also postpone the development of the test if every step needs to be FDA-approved. As we all know, MiSeq V2 just become the first NGS
machine to be FDA approved.

Having said that, diagnostic tests are in general much more lax in regulation compare to medicine. The key is to get a physician involved to turn it into an LDT. But 23andme still thinks that's too much trouble.
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Old 12-10-2013, 11:33 AM   #39
rskr
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Quote:
Originally Posted by ymc View Post
This can cause the prices to go sky high. Think about the $100K per year cancer targeted therapy drug that you can have at $1K if it were Indian generics.

It will also postpone the development of the test if every step needs to be FDA-approved. As we all know, MiSeq V2 just become the first NGS
machine to be FDA approved.

Having said that, diagnostic tests are in general much more lax in regulation compare to medicine. The key is to get a physician involved to turn it into an LDT. But 23andme still thinks that's too much trouble.
I don't see how administering more less effective tests would improve the cost. Since, a certain amount of money would be wasted on the test which wasn't provably conclusive. I wouldn't want to see a situation where the bad tests drive the good out.
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Old 12-10-2013, 06:36 PM   #40
gringer
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When you shift from single (or targeted) tests to whole genome, you're moving from a targeted model system to a probabilistic association. It's not possible to measure and account for every single interaction that happens across the genome, but it is quite possible to use genomic association tests to filter out obviously bad candidates (i.e. screening tests). I wouldn't want to use genome-wide tests for proof, but a single genome-wide analysis will be much cheaper for screening than targeted systematic tests for every disease under the sun.
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