PDA

View Full Version : 23andMe concerns



Rain
10-27-2013, 02:00 PM
I was planning on testing through 23andMe in the new year to learn more about my health. I was looking around to find out more about the company when I came across this article (http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-you-what-might-kill-you-inside-23andme-founder-anne-wojcickis-dna-r) which says;


As 23andMe scales, its business model will shift. Right now it gets most of its revenue from the $99 that people like me pay in return for test-tube kits and the results we get back after we send off our spit-filled tubes. "The long game here is not to make money selling kits, although the kits are essential to get the base level data," says Patrick Chung, a 23andMe board member and partner at the venture-capital firm NEA. "Once you have the data, [the company] does actually become the Google of personalized health care." Genetic data on a massive scale is likely to be an extremely valuable commodity to pharmaceutical companies, hospitals, and even governments. This is where the real growth potential is.

Should this be a cause for concern? I have no objections at all in contributing my data for scientific advancement, in fact one of the main reasons I did a DNA test in the first place was apart from the genealogical information was because I realised I was from a certain demographic which lacked data and it would help further our understanding of my demographic. However, a company building a huge database for the purpose of selling that information to the highest bidder for private gain seems concerning.

Seeing as quite a few of the members here have also tested with the company I would be interested to know how concerned they are and what anyone knows about the privacy policy of the company.

Joe B
10-27-2013, 06:07 PM
Genetic data on a massive scale is likely to be an extremely valuable commodity to pharmaceutical companies, hospitals, and even governments. This is where the real growth potential is.
Hopefully this will be for good and not evil.
An example of profit use of the data might be for a pharmceutical company. They could contract with 23andme to determine if there is an adequate market for a gene based therapy. I would guess that 23andme would retain proprietary computer/software and the massive database of dna. Thus making a profit from both the data and the ability to work the data.
I have found the health information to be very cool. They seem to have new health studies fairly often.
I'd say go for it. The NSA most likely already has your DNA anyway.

Cofgene
10-28-2013, 01:05 AM
23andMe's genetic data represents a subset of know mutations. As such it remains incomplete and of less value. There is additional value in this subset if the testers elect to answer the never ending list of background questions. If all of 23andMe's results were complete exomes there would be significant value present in the raw data.

Rain
10-28-2013, 05:41 PM
Thanks guys for your feedback, most likely I will get it anyway. I'm not too cut up about privacy concerns just that if they feel they're going to make their money not from the tests but from the data surely they could at least of given the tests for free :D

Clinton P
11-19-2013, 11:41 AM
November 18, 2013

23andMe’s New Custom Chip

The new version has been dubbed v4, and to quote 23and Me....

"We will likely start using the chip in the next few weeks".
"There are more than 600,000 SNPs on V4."
"The new chip is looking at fewer SNPs but because it is a custom chip, we are able to glean the information we need to report out the same information as the previous version. We can do this and improve the efficiency of processing the data."

Click here (http://blog.23andme.com/news/23andmes-new-custom-chip/) to read more about this story.

It is important to note that 23andMe are not calling this an upgrade.

I wonder what the implications will be for third party tools such as GEDmatch.

Clinton P

lgmayka
11-19-2013, 05:15 PM
From the article, both good and bad:
---
In addition, v4 includes SNPs that our researchers use to assign genetic ancestry using autosomal DNA markers as well as variants in both mitochondrial DNA and in the Y chromosome. The custom chip will also allow our researchers to better impute many variants present on larger chips. Imputation is a powerful statistical method that allows researchers to fill in missing data points. Researchers use publicly available full-sequence data, 23andMe’s own data and other sources to impute the genotype at specific locations.
---

- The new chip might test for recently discovered yDNA and mtDNA SNPs.

- In many cases, the chip will no longer test important locations. Instead, 23andMe will guess your allele based on what Utahans and Sardinians have at that location.

Both commercial and academic researchers need to understand that the few published full genomes are hopelessly biased in favor of Utahans and Sardinians. Any imputation based on those genomes will be bogus for anyone not from Utah or Sardinia.

Joe B
11-25-2013, 07:57 PM
FDA Tells Google-Backed 23andMe to Halt DNA Test Service

23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.”
Bloomberg http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html

AJL
11-25-2013, 08:36 PM
FDA Tells Google-Backed 23andMe to Halt DNA Test Service

Bloomberg http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html

Might be time to download all your data and reports.

Jean M
11-25-2013, 08:46 PM
The FDA can't stop 23andMe from operating outside the US. Not that 23andMe will get tossed out of the US without a struggle, but I dare say that if they have to move to Canada they will.

Jean M
11-25-2013, 09:01 PM
http://blogs.discovermagazine.com/gnxp/2013/11/fda-23andme/


First, download your 23andMe raw results now if you have them. If you don’t know what’s going on, the FDA has finally started to move aggressively against the firm. Unfortunately this is not surprising, as this was foreshadowed years ago. And, 23andMe has been moving aggressively to emphasize its medical, as opposed to genealogical, services over the past year. But this isn’t the story of one firm. This is the story of government response to very important structural shifts occurring in the medical delivery system of the United States. The government could potentially bankrupt 23andMe, but taking a step back that would still be like the RIAA managing to take down Napster. The information is coming, and if there’s one thing that can overpower state planning it is consumer demand. Unless the US government wants to ban their citizens from receiving their own genetic data they’re just putting off the inevitable outsourcing of various interpretation services. Engagement would probably be the better long term bet, but I don’t see that happening.

Jean M
11-25-2013, 09:22 PM
There is a petition to the White House already: https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB

And 23andMe's statement to the media:


We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

Joe B
11-25-2013, 10:28 PM
There is a petition to the White House already: https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB

And 23andMe's statement to the media:
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

The FDA has rules that have been in place for decades. There are ways to make a medical claim correctly based on science. 23andme has a good product. They just need to follow the rules. The TV ad campaign got the FDA's attention too.
Saving your 23andme data is a good idea anyway. This is a good reminder to do that. I just did. IMHO The raw data is alright, it's just the medical interpretation that is problematic until 23andme resolves the FDA's concerns. This will require more scientist than lawyers or ad agencies.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitrODiagnOstics/default.htm

Jean M
11-26-2013, 10:45 AM
The Washington Post: The FDA should leave 23andMe alone

http://www.washingtonpost.com/blogs/the-switch/wp/2013/11/25/the-fda-should-leave-23andme-alone/


If the PGS is inaccurate, or if 23andMe makes misleading claims about its capabilities, that would be legitimate grounds for regulation. But the FDA seems to be making a stronger, and much more dubious, claim: that even an accurate genetic test is dangerous because its results could be misinterpreted by patients.

The FDA's own example shows how weak this argument is. Obviously, it would be terrible if a woman got a false positive for a breast cancer gene and got an unnecessary mastectomy or chemotherapy as a result. But mastectomies and chemotherapy are not available over the counter. To get them, patients have to seek treatment from licensed physicians. If 23andMe's BRCA test is unreliable, doctors will be aware of this fact, order a more reliable test and help the patient to properly interpret it.

Alpine Hominin
11-26-2013, 04:41 PM
Anyone know whats going on with kits already in testing? Mines been "Going through a second round of DNA Isolation" for a while and reading about this has me worried. I ordered back in October and a refund would make me bitter.

rossa
11-26-2013, 10:14 PM
The Washington Post: The FDA should leave 23andMe alone

http://www.washingtonpost.com/blogs/the-switch/wp/2013/11/25/the-fda-should-leave-23andme-alone/

I wonder down the road at some point if people get results that they take drastic action on will there be law suits against 23andme?

Jean M
11-26-2013, 11:08 PM
People can't generally take drastic action without the involvement of medical professionals. I can't see anyone giving themselves heart surgery in their kitchen. So the argument that DNA testing needs to be chanelled through medical professionals makes no sense. The results of the tests are already being passed on to medical professionals if testees have concerns, which is exactly what 23andMe recommends.

GTC
11-27-2013, 12:22 AM
And 23andMe's statement to the media:


We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.


Given that the FDA's warning letter letter says this has been ongoing for 5 years, I think the FDA would find the above statement from 23andMe laughable.

Jean M
11-27-2013, 10:42 AM
There is an update today: http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme/ which includes the schedule:


In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.

In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.

This is new territory for both for 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.

Jean M
11-27-2013, 06:07 PM
Berin Szoka is rooting for another petition: https://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits Running concurrently with the one on whitehouse.gov that I mentioned above, this one permits non-US citizens to sign. Both have over 2,000 signatories as I write.

FDA Just Banned 23andMe's DNA Testing Kits, and Users Are Fighting Back
http://www.huffingtonpost.com/berin-szoka/fda-just-banned-23andmes-_b_4339182.html


Since 23andMe launched in 2007, over 500,000 Americans have had their saliva tested to learn more about their ancestry, health risks and genetic predisposition to a wide variety of factors. The price has plummeted ten-fold: just $99 for the home-test kit. The scrappy company was poised to take its product mass-market with marketing campaigns aimed at user numbers into the millions.

Perhaps that's why the Food and Drug Administration finally cracked down on the site. Today, the FDA shut down further sales of the saliva home-test kit, citing the "potential health consequences that could result from false positive or false negative assessments for high-risk indications....

23andMe is simply doing what the Internet does best: forcing old dogs to learn new tricks. That's what the fight between Uber and taxicab commissions is about. Same for AirBnB and hotel regulators. The only profession slower to change how they do things than doctors is bureaucrats. So the FDA's reaction is understandable -- but misguided....

We're urging the FDA not to short-circuit this revolution, and have launched a Change.org petition to rally those who agree. Our message is simple: "Please trust us -- and our doctors -- to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing."

Those of us who have already used the site know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn't know where to begin. But the more of us ask about 23andMe, the more the medical profession is catching up. Slowly but surely, they're brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them.

geebee
11-27-2013, 07:30 PM
This seems to me to be factually incorrect:

"This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."

When I look at my health reports, I see no diagnoses. I do see that I may have certain risk factors, but my bathroom scale can tell me that. It is not thereby a "medical device".

I can buy any number of books that will give me the same sort of advice that 23andMe does. Yes, they do suggest steps I can take to better my prospect of maintaining good health. But these steps typically are of the "eat less, exercise more, don't smoke" nature.

Of course, one difference between 23andMe and the books is that 23andMe also provides an analysis of my DNA, which enables them to tell me of conditions I MAY possibly want to be aware of. Therein lies the rub.

It seems to me that the only way 23andMe could comply with the FDA's wishes would be to do what other companies have done -- "scrub" any SNPs that might be medically relevant, and focus only on the genetic genealogy side of things. I doubt that 23andMe would do this, but would simply fold.

The truth is, while FDA claims they recognize the right of an individual to know his or her genomic information, they seem to have no interest in making this feasible. Deprived of the availability of 23andMe, few people will go to their doctors to arrange for "FDA approved" genetic testing.

FDA makes the ludicrous suggestion that 23andMe's "Health Reports" might lead to things such as a prophylactic mastectomy -- which obviously means they have no confidence in the medical community that would have to be involved in such a thing -- but they also give no credit to any possible POSITIVE outcomes of genetic knowledge. I supposedly have a higher than average risk of venous thromboembolism. I also fly from Asia to the U.S. and back, multiple times a year. So, I take a little effort to make sure I move around the cabin, I wear compression socks, things of that sort. Those things are unlikely to hurt me even if I were NOT at higher risk.

Lastly, I'm not quite sure how I found this little tidbit, but I think it may be of interest to some: http://knowerror.com/clinical-studies-support-dna-testing-on-biopsy-samples-to-prevent-misdiagnoses/

"Know Error" seems to be a company interested in profiting from DNA testing. They reported publication of a couple of peer reviewed studies. One, "published in the American Journal of Clinical Pathology, found that up to 3.5 percent of patients initially diagnosed with cancer were subject to undetected biopsy sample switches or contaminations which may have compromised the accuracy of their diagnosis. Results were based off the analysis of approximately 13,000 prostate biopsies collected as part of routine clinical care and processed in more than 50 pathology laboratories."

The other study "evaluated the potential economic value of prospective DNA Specimen Provenance Assignment (DSPA) testing as a solution to preventing misdiagnoses resulting from biopsy misidentification."

As an American, I find it SO comforting to see that our FDA is looking out for the interests of the Medical Community and Big Pharma.

EDIT: I wonder how concerned the FDA is about that reported 3.5% error rate? This is not 23andMe's error rate, but apparently involves pathology labs doing prostate biopsies. Oops.

Joe B
11-27-2013, 08:08 PM
Finally, I don't remember exactly how I came across this little tidbit, but I think it has some relevance: http://knowerror.com/clinical-studies-support-dna-testing-on-biopsy-samples-to-prevent-misdiagnoses/

"Know Error" seems to be a company interested in profiting from DNA testing. They reported publication of a couple of peer reviewed studies. One, "published in the American Journal of Clinical Pathology, found that up to 3.5 percent of patients initially diagnosed with cancer were subject to undetected biopsy sample switches or contaminations which may have compromised the accuracy of their diagnosis. Results were based off the analysis of approximately 13,000 prostate biopsies collected as part of routine clinical care and processed in more than 50 pathology laboratories."

The other study "evaluated the potential economic value of prospective DNA Specimen Provenance Assignment (DSPA) testing as a solution to preventing misdiagnoses resulting from biopsy misidentification."

As an American, I find it SO comforting to see that our FDA is looking out for the interests of the Medical Community and Big Pharma.

EDIT: I wonder how concerned the FDA is about that reported 3.5% error rate? This is not 23andMe's error rate, but apparently involves pathology labs doing prostate biopsies. Oops.


Do we know ther error rate for 23andme? For each individual medical SNP? There are few absolutes in medicine but a known error rate should be presented as part of the FDA package. Big Pharma and everybody else gets slapped by the FDA for this kind of stuff all the time. It's not unusual for Pharma marketing to go over the line and have their material put on probation by the FDA. They haven't even fined 23andme yet! I'm all for the 23andme test and the medical information it provides. But if they are going to suggest considering a higher dose of an over-the-counter medicine or an Rx based on SNPs like they did the other day with me, they better have their act together. 23andme has the resources to do this right and I don't see the conspiracy.

jeanL
11-27-2013, 08:46 PM
Do we know ther error rate for 23andme? For each individual medical SNP? There are few absolutes in medicine but a known error rate should be presented as part of the FDA package. Big Pharma and everybody else gets slapped by the FDA for this kind of stuff all the time. It's not unusual for Pharma marketing to go over the line and have their material put on probation by the FDA. They haven't even fined 23andme yet! I'm all for the 23andme test and the medical information it provides. But if they are gong to suggest considering a higher dose of an over-the-counter medicine or an Rx based on SNPs like they did the other day with me, they better have their act together. 23andme has the resources to do this right and I don't see the conspiracy.

The only source of error I could think of with respect to 23andme would be an allele misread of a SNP. This does seem to happen, and there is a way to check it, that would be to check your DNA against one of your parent DNA, and look for mismatches. However there are probabilities of somatic mutations occuring. In any case we have to remember that a lot of these medical association are based upon scientific studies, and while some of them have been reproduced, they are likely tons of SNPs be them functional or nonfunctional that play either a pathological or protective role in diseases that are yet to be discovered.

Here to put some real numbers into the discussion, using the following program (http://www.math.mun.ca/~dapike/FF23utils/trio-discord.php) I compared my DNA to my parents, and here is what I found:

960613 autosomal SNPs were processed
198 autosomal SNPs were discordant

So the error rate would be 198/960613=0.02% assuming all of these are misreads, and not actual somatic mutations or germline mutations.

Grossvater
11-27-2013, 11:58 PM
I was pretty happy with my results from 23andMe. Finding that I have inherited my grandmother's heightened sensitivity to blood thinners may be especially valuable in the future. I wish she had known because it killed her.

The only things I've scratched my head over are the results that tell me I am likely lactose tolerant when I am most definitely NOT and that my wife is likely lactose intolerant but in fact drinks all the milk she wants with no trouble.

Joe B
11-28-2013, 12:54 AM
This letter just sent to 23andme customers. Anne Wojcicki got the message.


Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

ajmr1a1
11-28-2013, 01:05 AM
The only source of error I could think of with respect to 23andme would be an allele misread of a SNP.

Two people in my family got "no calls" from 23andme on the APOE SNP for Alzheimer's. (see quote below)
This disease is one of the reasons the test was purchased in the first place.
Should I demand a re-test?
And/or bring this to the FDA's attention?

This person "does not have data for one or more of the genetic markers required to estimate risk of Alzheimer's Disease. Of the over half a million markers that 23andMe genotypes, typically 0.3% of them will not produce data for an individual, which may, in rare cases, include markers used in Health reports. The exact number and markers with no data will vary from person to person."

GTC
11-28-2013, 01:42 AM
The only things I've scratched my head over are the results that tell me I am likely lactose tolerant when I am most definitely NOT and that my wife is likely lactose intolerant but in fact drinks all the milk she wants with no trouble.

I think the scientific jury is still out on exactly which genes are responsible:

http://en.wikipedia.org/wiki/Lactase_persistence

Jean M
11-29-2013, 04:09 PM
Two people in my family got "no calls" from 23andme on the APOE SNP for Alzheimer's. ...

This person "does not have data for one or more of the genetic markers required to estimate risk of Alzheimer's Disease. Of the over half a million markers that 23andMe genotypes, typically 0.3% of them will not produce data for an individual, which may, in rare cases, include markers used in Health reports. The exact number and markers with no data will vary from person to person."

That is disappointing. I see that 23andMe says "Some people will receive incomplete results for this report. This is because the APOE variants are more difficult to determine with genotyping technology than most other genetic variants."

I don't have an answer, but I can point to coverage in the New Scientist of the idea that Alzheimer's Disease is a form of Type 2 Diabetes. http://www.newscientist.com/section/health . If so it might be helpful to look at your risk for the latter.

Ann Turner
11-29-2013, 07:11 PM
Here to put some real numbers into the discussion, using the following program (http://www.math.mun.ca/~dapike/FF23utils/trio-discord.php) I compared my DNA to my parents, and here is what I found:

960613 autosomal SNPs were processed
198 autosomal SNPs were discordant

So the error rate would be 198/960613=0.02% assuming all of these are misreads, and not actual somatic mutations or germline mutations.
Or you could even say the error rate is 198/(3*960613) since you're looking at three sets of results. And come to think of it, two alleles for each SNP.

ajmr1a1
12-06-2013, 02:08 AM
I found this new notice when signing in today.

Welcome to 23andMe.

At this time, we have suspended our health-related genetic tests to comply immediately with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.

We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.

If you are an existing customer please click the link below and then go to the health page for additional information. If you are a customer that purchased before 11/22/13, you will still have access to your health-related results.

We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.

Upon entering the site, please confirm you understand the new changes in our services.

I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization.

I UNDERSTAND

geebee
12-06-2013, 09:17 AM
But if they are going to suggest considering a higher dose of an over-the-counter medicine or an Rx based on SNPs like they did the other day with me, they better have their act together. 23andme has the resources to do this right and I don't see the conspiracy.

I, at least, never used the word "conspiracy". You don't have to believe in any "conspiracy" to recognize that all regulatory bodies are subject to various pressures, including from some of the very companies they regulate.

But, to your point: They don't at any point suggest that people should adjust doses on their own, at least not in any Health Reports I've seen. Here are two specific examples of what they actually say (which is no different now than before the FDA letter):

In a new report on "Protein Pump Inhibiter Metabolism", they identify me as an "Ultrarapid or rapid metabolizer." But they don't say simply, "You should have a higher dose." Instead they suggest that "Someone with this genotype typically metabolizes PPIs at a rapid rate. Although the standard dose is usually effective, some people with this genotype may benefit from a different dose, especially if being treated for an H. pylori infection. If you are currently taking a PPI, it is important to talk to your doctor if your symptoms do not improve."

Now for warfarin, they suggest I may have "Slightly increased warfarin sensitivity" and "May require decreased warfarin dose. There's no suggestion here that I definitely require a decreased dose, or that I should alter the dosage on my own. In fact, they say, "Only a medical professional can determine the right dosage of warfarin for a particular patient." They also mention that proper dosage involves additional factors, including the amount of vitamin K in one's diet.

The "bolding" is my doing; it isn't in bold in the report. Even so, I don't see anything radical in these recommendations -- certainly not anything to raise the ire of the FDA. Since I'm not now taking warfarin, it isn't an issue for me. But if I were to take warfarin in the future, why should it be such a great problem for me to say, "By the way, Doc, I've got this report ..." One would hope that a doctor would welcome such information. It needn't be relied on as "gospel", but only as a place to start.

GTC
12-06-2013, 10:26 AM
As if it needed another legal problem, 23andMe is now subject of a $5million class action in California claiming "that its ads are misleading and that the results are not supported by scientific evidence."

Joe B
12-06-2013, 04:59 PM
I, at least, never used the word "conspiracy". You don't have to believe in any "conspiracy" to recognize that all regulatory bodies are subject to various pressures, including from some of the very companies they regulate.

But, to your point: They don't at any point suggest that people should adjust doses on their own, at least not in any Health Reports I've seen. Here are two specific examples of what they actually say (which is no different now than before the FDA letter):

In a new report on "Protein Pump Inhibiter Metabolism", they identify me as an "Ultrarapid or rapid metabolizer." But they don't say simply, "You should have a higher dose." Instead they suggest that "Someone with this genotype typically metabolizes PPIs at a rapid rate. Although the standard dose is usually effective, some people with this genotype may benefit from a different dose, especially if being treated for an H. pylori infection. If you are currently taking a PPI, it is important to talk to your doctor if your symptoms do not improve."

Now for warfarin, they suggest I may have "Slightly increased warfarin sensitivity" and "May require decreased warfarin dose. There's no suggestion here that I definitely require a decreased dose, or that I should alter the dosage on my own. In fact, they say, "Only a medical professional can determine the right dosage of warfarin for a particular patient." They also mention that proper dosage involves additional factors, including the amount of vitamin K in one's diet.

The "bolding" is my doing; it isn't in bold in the report. Even so, I don't see anything radical in these recommendations -- certainly not anything to raise the ire of the FDA. Since I'm not now taking warfarin, it isn't an issue for me. But if I were to take warfarin in the future, why should it be such a great problem for me to say, "By the way, Doc, I've got this report ..." One would hope that a doctor would welcome such information. It needn't be relied on as "gospel", but only as a place to start.

My statement was regarding 23andme's dealings with FDA. Just because 23andme uses language that protects against consumer lawsuits, that does not protect them from FDA regulations. I specifically chose the over-the-counter example since the physician may be out of the loop anyway. The FDA has to look at the "real world" and that is more complicated than the "see your doctor" standard legal disclaimer.

"Someone with this genotype typically metabolizes PPIs at a rapid rate. Although the standard dose is usually effective, some people with this genotype may benefit from a different dose, especially if being treated for an H. pylori infection. If you are currently taking a PPI, it is important to talk to your doctor if your symptoms do not improve."
I've highlighted the concern and not the disclaimer.

23andme has a potentially great product that could benefit many people. They still have to follow the rules.
The word "conspiracy" is a favorite. Especially when the conspiracy doesn't exist.

Edit: @geebee,
I certainly do not think you or anybody else on this forum were implying a conspiracy.
:beerchug:

Jean M
12-06-2013, 05:27 PM
https://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits
This petition has passed the half-way mark in the number of signatories. The other petition seems to have stalled.

ajmr1a1
12-06-2013, 06:00 PM
Even so, I don't see anything radical in these recommendations -- certainly not anything to raise the ire of the FDA. Since I'm not now taking warfarin, it isn't an issue for me. But if I were to take warfarin in the future, why should it be such a great problem for me to say, "By the way, Doc, I've got this report ..." One would hope that a doctor would welcome such information. It needn't be relied on as "gospel", but only as a place to start.

The place to start is for 23andme to prove that their test is accurate by providing all the data with regard to their quality control per the FDA's request.

The consumer has to be guaranteed a reasonable expectation of accurate raw data which meets the FDA medical device standards. Completely erroneous or incomplete SNP results (no-calls) are a problem for the FDA.

To 23andme's credit, they have agreed to re-test a no-call medical SNP at my request.
However, 23andme made it clear that they cannot test more than twice since
that would exhaust the available DNA in storage.

Jean M
12-06-2013, 11:01 PM
http://blog.23andme.com/news/23andme-provides-an-update-regarding-fdas-review/


After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review.

23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers. I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future. Our goal is to work cooperatively with the FDA to provide that opportunity.

We also want to make clear that we stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.

As we work with the FDA to get clearance, there will be some significant changes to the site. Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.

Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.

This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team.

Research is and will continue to be a significant priority for the company. The 500,000+ customers we have today have given us more than 250 million survey data points. You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014.

23andMe will also continue educational efforts to consumers, physicians and other health providers as we believe genetics will be an increasingly important part of all of our lives.

Finally, I want to say thank you to our customers for your support and your stories. Many of you have written in about how 23andMe has changed your life. It is rewarding for me and all the employees at 23andMe to serve our customers. I am committed to 23andMe and committed to being a pioneer in the genetics revolution.

geebee
12-07-2013, 03:28 AM
The place to start is for 23andme to prove that their test is accurate by providing all the data with regard to their quality control per the FDA's request.

The consumer has to be guaranteed a reasonable expectation of accurate raw data which meets the FDA medical device standards. Completely erroneous or incomplete SNP results (no-calls) are a problem for the FDA.

To 23andme's credit, they have agreed to re-test a no-call medical SNP at my request.
However, 23andme made it clear that they cannot test more than twice since
that would exhaust the available DNA in storage.

Who decides what's reasonable? Obviously, some customers will believe that getting a call on every SNP they're interested in is "reasonable". Or that even though 23andMe can check for many things for $99, it should be equal to a $500 test that does only one thing.

I suspect if FDA sees things your way, there will really be no good way forward for 23andMe.

EDIT: It's difficult to find costs for other company's tests, but I found one source that gives APOE results-- only -- for $150, Hey, maybe that would work for 23andMe? They can just say, if you absolutely must have the result for a particular SNP or set of SNPs, we'll ensure that you get that ,,, but then don't expect any other results.

Any customer who doesn't get calls on SNPs he's interested in is certainly free to request re-testing. I think it's a bit much to demand it, but that's just my opinion. Possibly, the company should make it clearer up front that since they are not performing a specialty test for any single SNP or set of SNPs, they cannot guarantee results for every one of them.

Why should customers expect to pay less for getting results relevant to many (potential) health issues than they would for just one, yet at the same time feel "cheated" because they didn't get results for the one thing they were interested in?

geebee
12-07-2013, 04:17 AM
Joe, Prilosec -- one of the PPIs -- itself gives information as to circumstances in which a higher dose may be needed, as well as what dosages may still be considered safe, and how to take higher doses. Presumably, this is all FDA approved. But at the Prilosec site -- accessible by anyone, not just doctors -- there isn't even as explicit "check with your doctor" so far as I could see. Perhaps they assume patients won't go to their website?

EDIT: Let's think about the concern that patients just read the 23andMe info and up their dosages on their own. It's certainly possible. But unless a medicine is given in a hospital, the patient is controlling dosage anyway, is he not? So if I'm a PPI rapid metabolizer and I find the prescribed dose isn't enough, am I any LESS likely to bump up my dose? Whereas if I know I'm a rapid metabolizer, I mention that to my doctor when I go to him because of "gastric distress", I can mention that to him and he can take it any account. You see a problem with this?

My point is, the FDA's "concern" is realistically no less of a concern with or without the information from 23andMe. Which, in fact, unlike Prilosec's website, explicitly tells you see "consult your doctor" before adjusting your dosage. (Granted, maybe Prilosec assumes its site visitors are ALL doctors.)

Joe B
12-07-2013, 05:48 AM
Joe, Prilosec -- one of the PPIs -- itself gives information as to circumstances in which a higher dose may be needed, as well as what dosages may still be considered safe, and how to take higher doses. Presumably, this is all FDA approved. But at the Prilosec site -- accessible by anyone, not just doctors -- there isn't even as explicit "check with your doctor" so far as I could see. Perhaps they assume patients won't go to their website?

EDIT: Let's think about the concern that patients just read the 23andMe info and up their dosages on their own. It's certainly possible. But unless a medicine is given in a hospital, the patient is controlling dosage anyway, is he not? So if I'm a PPI rapid metabolizer and I find the prescribed dose isn't enough, am I any LESS likely to bump up my dose? Whereas if I know I'm a rapid metabolizer, I mention that to my doctor when I go to him because of "gastric distress", I can mention that to him and he can take it any account. You see a problem with this?

My point is, the FDA's "concern" is realistically no less of a concern with or without the information from 23andMe. Which, in fact, unlike Prilosec's website, explicitly tells you see "consult your doctor" before adjusting your dosage. (Granted, maybe Prilosec assumes its site visitors are ALL doctors.)
geebee, The reality is Prilosec is a pretty safe drug as is it's prescription counterpart Nexium. The proton pump inhibitors and the H2 antagonist before them have cut the incidence of stomach cancer tremendously.

The trouble is with meeting FDA standards. 23andme was naive to think they would be held to a lesser standard than other companies. That was a very bad business decision by a company that never dealt with the FDA before. Based on the latest communications from 23andme, they seem less naive and now have lawyers that know the FDA. Once they have FDA blessing the medical community will take 23andme results more seriously and so will I.
Hopefully, this will work out in the end.

Found the disclaimer.
Defining Frequent Heartburn - And Why It Matters (http://www.prilosecotc.com/heartburn-tips/defining-frequent-heartburn)

Joe B
12-07-2013, 06:03 AM
The place to start is for 23andme to prove that their test is accurate by providing all the data with regard to their quality control per the FDA's request.

The consumer has to be guaranteed a reasonable expectation of accurate raw data which meets the FDA medical device standards. Completely erroneous or incomplete SNP results (no-calls) are a problem for the FDA.

To 23andme's credit, they have agreed to re-test a no-call medical SNP at my request.
However, 23andme made it clear that they cannot test more than twice since
that would exhaust the available DNA in storage.

Seems very reasonable and fair for both parties.

ajmr1a1
12-07-2013, 02:19 PM
Who decides what's reasonable? Obviously, some customers will believe that getting a call on every SNP they're interested in is "reasonable".

EDIT: It's difficult to find costs for other company's tests, but I found one source that gives APOE results-- only -- for $150, Hey, maybe that would work for 23andMe? They can just say, if you absolutely must have the result for a particular SNP or set of SNPs, we'll ensure that you get that ,,, but then don't expect any other results.

Any customer who doesn't get calls on SNPs he's interested in is certainly free to request re-testing. I think it's a bit much to demand it, but that's just my opinion. Possibly, the company should make it clearer up front that since they are not performing a specialty test for any single SNP or set of SNPs, they cannot guarantee results for every one of them.


@GeeBee

Who decides what's reasonable? The FDA.

If 23andme complied with CLIA, why didn't they surrender their quality control data to the FDA?

In your opinion GeeBee, is it reasonable for 23andme to hide this information from the governmental regulatory body called the FDA?

vettor
12-07-2013, 06:06 PM
IMO, 23andme main source of income was on-selling "medical results" to other agencies. Their DNA for ancestry leaves a lot to be desired.......they are still using ydna and mtdna trees from 2009.

Take the medical side away from 23andme and I see nothing of note ..............or, someone can advise me what other benefit they do

leonardo
12-07-2013, 08:32 PM
IMO, 23andme main source of income was on-selling "medical results" to other agencies. Their DNA for ancestry leaves a lot to be desired.......they are still using ydna and mtdna trees from 2009.

Take the medical side away from 23andme and I see nothing of note ..............or, someone can advise me what other benefit they do

While one may argue about its accuracy, 23andMe has a number of tools for those searching for genetic matches that are appealing. It also is user friendly for this purpose. While FTDNA has made some recent strides in this are, I would say 23andMe still has the edge. Truth be told, Gedmatch's oracles tools are probably more of a benefit then Ancestry Composition.

geebee
12-08-2013, 08:14 AM
@GeeBee

Who decides what's reasonable? The FDA.

If 23andme complied with CLIA, why didn't they surrender their quality control data to the FDA?

In your opinion GeeBee, is it reasonable for 23andme to hide this information from the governmental regulatory body called the FDA?

What is "reasonable" calls for a value judgement. Clearly, the FDA may consider anything it requires to also be reasonable. That does not mean this is correct, only that where FDA has the power, FDA can make the demands.

But I was speaking not so much of what's "reasonable" in terms of regulation, but of customer expectations. FDA's mandate is not consumer satisfaction, but consumer safety. In that regard, there is a significant difference between "no calls" and "miscalls". A no call cannot possibly lead to either a false positive or a false negative, and so should be of less interest to the FDA than a miscall.

Even where FDA may decide what is "reasonable" (or actually, what is "required"), they do not necessarily have the final say, since the FDA has on more than one occasion been overruled by the courts. It is also entirely "reasonable" for the maker of a product which may come under the provenance of the FDA, to seek to negotiate how the product is to be classified. Has 23andMe done rather poorly in this regard? Probably, but again we don't know how "reasonable" the FDA was on its part. Being able to make the rules is no guarantee of good rules.

Now, as to your questions, they involve assumptions as to the facts. Perhaps you have inside information, but I do not. I do not, for example, know either the precise details of what FDA asked for, nor exactly what information 23andMe gave or withheld. Do you? Or are you relying, as I am, only on what you have read?

In regard to QC, are you saying that 23andMe does not, in fact, use a CLIA-certified laboratory, as they say they do? (LabCorp, I thought.) And that this lab does not in fact already meet FDA standards? And that it's "reasonable" for 23andMe to have to separately confirm that the lab is meeting the standards, even though that's what CLIA certification means?

In regard to "hiding" something, you actually know that they are? Not supplying information you either don't have, or don't think is reasonable to expect, is not equivalent to "hiding" anything. The police often say a witness is not being "cooperative", but that doesn't make it true. It only means there's something they've asked for and not gotten, or not gotten to their satisfaction. It doesn't tell us why.

Actually, your second question is a bit like asking whether is unreasonable for a man to stop beating his wife. If he is doing so, it isn't unreasonable to tell him to stop. But if he never has done so, he cannot stop what never began.

Ultimately, my concern isn't that FDA necessarily has no regulatory role, but only that they lack an appropriate model. If they can only use the existing model, and it doesn' "fit", there is a problem.

The problem is that using the wrong model is like trying to wear someone else's shoes. If they don't fit well, they can actually injure your feet. It's rather like the version of the Cinderella story in which the step-sisters actually do both manage to put on the slipper. Trouble is, one had to cut off her toes, and the other had to cut off her heel, and in the end both simply had maimed feet and no prince.

EDIT: I suppose as long as I'm making foot-related analogies, I might as well make one more. Here in Malaysia, it's customary to take off one's shoes when you enter someone's home. Sometimes a host or hostess will provide slippers, sometimes not.

Now, if someone comes to my apartment, I figure I have some say in what is "appropriate". Suppose a guest has some sort of "foot problems". Do I say, "everyone has to follow the same rule, no shoes"? Or, if it's needful for someone to keep his orthotic shoes, do I permit it?

You seem to think that the service 23andMe is offering should be judged the same as if they were doing only a test of, say, APOE status. Except because they're testing many different conditions, they should meet the same standard for everyone of them.

Or if this simply isn't feasible, then the service should not be allowed to exist in the first place.

What I don't understand is, why does it have to be "all" or "nothing"? I think this is what us unreasonable about FDA's expectations. 23andMe must be the equal of every specialty test that it might give information relevant to, at an extraordinarily low cost, or else it can't operate at all. So let's all just pay $1000+ for what we get from 23andMe for a tenth that, and only if our doctors requests the tests for us?

2nd EDIT: If your answer to "why" is that the FDA has to work within it's own regulatory framework, that's true. But if they recognized that 23andMe is different, you'd think they could at least be saying "we don't think this a perfect fit, but until the regs are changed, we're stuck with what we've got." That doesn't seem to be what they're doing, which suggests they don't see the difference. And that is why they're being unreasonable.

3rd EDIT: "The FDA is not, however, tasked with overseeing the analytical validity – in other words, the accuracy and reliability – of genetic tests. Ensuring analytical validity is the responsibility of the Centers for Medicare & Medicaid Services (CMS), which enforces the Clinical Laboratory Improvement Amendments of 1988, or CLIA. Under CLIA, labs that perform human testing, including genetic testing, are regulated through a certification process. For a lab to obtain CLIA certification, it must satisfy CMS requirements relating to quality control, personnel qualifications, records maintenance, and proficiency testing. CLIA certification also requires the laboratory to demonstrate the analytical validity of its tests." http://www.genomicslawreport.com/index.php/2010/06/09/23andme-sample-swap/

So, you may still say that it's reasonable for FDA to inquire into the QC of 23andMe's lab, but it looks as if it may not in fact be the FDA's business, but the business of a different federal agency. If 23andMe pointed this out -- basically by saying "our lab is CLIA certified" -- does this mean they're "hiding" something, or only that they see no reason to seek approval for something already approved?

By the way, the original article from which the quotation was taken was about 23andMe's notorious "sample swap" in 2010. Sample swaps also occur, however, in FDA approved lab tests. Normally, this is not an issue for the FDA, but for whatever regulatory agency or agencies are overseeing the labs in question.

FDA doesn't oversee everything.

Táltos
12-08-2013, 03:22 PM
In regard to LabCorp being CLIA certified they would absolutely have to be as they are a major laboratory facility. I wonder if the problem lies within 23andme itself perhaps not keeping the actual QC records on their own site for their tests? I would imagine that the 23andme offices in California are just for maybe collecting sales orders, maybe and it is a big maybe for customer service. They do not answer their phone number, they will give updates about things on their forum that is about it. I work for a health clinic and we have a small lab on site. We are CLIA certified and it requires keeping records, logs, of all QC of tests, and also of quarterly API testing which must be done within certain time frames. We also have to have records that staff are properly trained to perform testing. We also have to ensure no lab supplies are out dated. However there are tests that we have to send out to bigger labs such as LabCorp and Quest. We would not have any record of how they quality control testing for say one of the STD tests that we would send to them. So it makes me wonder if it is more of the fact the FDA found a loophole in to strong arm 23andme? I do see the points of this issue from both sides. However 23andme has from the start placed obvious disclaimers next to all of their medical results about consult your doctor, consult a genetic counselor. Patients in general are notorious for being "non-compliant" with medications and taking them however they want. I am guilty myself with how I take my acid reflux medication!

Here is something else interesting that I found under the news section of LabCorp today, notice the date on it. I wonder how this figures in to all of this. http://phx.corporate-ir.net/phoenix.zhtml?c=84636&p=irol-newsArticle&ID=1881008&highlight=

ajmr1a1
12-09-2013, 12:45 AM
Deleted by poster

ilmari
12-09-2013, 03:45 AM
The model I am using is the "scientific method."
You can Google the definition if you wish.

23andme is using one technology (the Illumina chip) to assess all the SNPs.
A miscall error on the APOE SNP or earwax SNP is the same thing.
Science says it's an error. Period.

Whether it's a "speciality" test or a "run-of-the-mill" test, it must adhere to the standards of the scientific method, or it's garbage. (i.e. accuracy, reproducibility etc)

23andme isn't Orville Reddenbacher popcorn. (nearly every kernal popped)
The Food and Drug administration is not going to come down hard on Old Orville
if too many kernels aren't popped. 23andme is a different matter.

23andme is a company offering a service based on SCIENCE and
not conjecture, innuendo and children's stories.

Please refrain from your edgy attacks, geebee is a seasoned poster and knows what he's talking about, he's been involved with genetic genealogy circles for years, you, ajmr1a1, seem too naive to be attacking anyone on this forum, you've been warned.

ajmr1a1
12-10-2013, 07:00 PM
Please refrain from your edgy attacks, geebee is a seasoned poster and knows what he's talking about, he's been involved with genetic genealogy circles for years, you, ajmr1a1, seem too naive to be attacking anyone on this forum, you've been warned.

Your warning is unwarranted.
I am attacking no one.
Everything contained in my post is a fact.

Please feel free to delete anything that I have posted that you find offending.

Goodbye Anthrogenica!

Cofgene
12-11-2013, 02:15 AM
So it makes me wonder if it is more of the fact the FDA found a loophole in to strong arm 23andme? I do see the points of this issue from both sides. However 23andme has from the start placed obvious disclaimers next to all of their medical results about consult your doctor, consult a genetic counselor.

23andMe did not specifically label the kit and the results along the lines of “for research use only” or "For investigational use only" as is required by the regulators. The lack of this type of disclaimer places the kit and the subsequent analysis into the fully validated realm. With the disclaimer they would have time to perform the required studies to "validate" the published medical trait results. Since they are not a research organization like Coriell they have stricter rules to abide by when providing interpreted results based upon the acquired data.

thetick
12-11-2013, 02:43 AM
23andMe did not specifically label the kit and the results along the lines of “for research use only” or "For investigational use only" as is required by the regulators.

23andme is clearly guilty of not strictly following the FDA guidelines. I don't think there is much to argue there. For the common consumer the omission of a few words that they will not even read does not matter. The phrases "for research use only” or "For investigational use only" are completely meaningless to the consumer unless one is a lawyer, regulator or paid FDA consultant.

Unfortunately lawyers, regulators and paid FDA consultants influence to the point of writing the the laws.

Táltos
12-11-2013, 03:50 AM
23andMe did not specifically label the kit and the results along the lines of “for research use only” or "For investigational use only" as is required by the regulators. The lack of this type of disclaimer places the kit and the subsequent analysis into the fully validated realm. With the disclaimer they would have time to perform the required studies to "validate" the published medical trait results. Since they are not a research organization like Coriell they have stricter rules to abide by when providing interpreted results based upon the acquired data.
What I was thinking about with a loophole for the FDA, was if 23andme did not keep the actual QC records for their tests in their office in Mountain View,CA. Honestly I don't remember what the kit said when it arrived at my house in the way of "for research use only" or not. Like the tick said for the common consumer (ie me!) the omission of a few words is meaningless. I only tested my Mom there for the genetic genealogy side of it. I do know when her results first came in (Feb.2013) the disclaimers could be seen next to her medical results. Also on the homepage all those quizzes always had 23andme Research written next to it. I do understand the other side of things from the FDA perspective. As the average consumer I really feel that my government is overreaching, as usual.

BTW I like your Nationality! :biggrin1:

ilmari
12-11-2013, 08:06 AM
Your warning is unwarranted.
I am attacking no one.
Everything contained in my post is a fact.

Please feel free to delete anything that I have posted that you find offending.

Goodbye Anthrogenica!

Thank you for the advice, but I believe it is best to leave public comments as they were originally written. Goodbye to you as well.

AJL
01-11-2014, 06:24 PM
Another article on 23 from the Canadian media:

http://www.ottawacitizen.com/health/Tempest+test+tube+trouble+with+mail+order+genetic+ testing/9346563/story.html

Caburn
01-17-2014, 12:00 AM
The BBC radio programme called 'Science Now', broadcast today, included some discussion of the FDA and 23andMe issues:

From the BBC Science Now webpage:

For a couple of hundred quid, one of many companies will send you a kit for sampling your own genome, and most will tell you your genetic risk for some diseases. In December the US Food and Drug Administration imposed a ban on one of these companies, 23andme. The reasoning was that if the organisation is offering medical advice, it needs to be medically regulated. Geneticist Professor Robert Green from Harvard Medical School argues that people can cope responsibly with their genetic information and that the FDA is being over-cautious.

The programme is available to listen to via the BBC iPlayer within the UK, and possibly elsewhere*, using the following link:

http://tinyurl.com/loufvjx

(*BBC TV via the iPlayer is geo-blocked beyond the UK but that might not apply to BBC Radio - I'm not sure.)

AJL
01-17-2014, 04:23 PM
^ Not blocked, thanks!

Jean M
01-17-2014, 09:47 PM
23andMe and Udacity Launch ‘Massive Online Open Course’ in Human Genetics
http://www.darkdaily.com/23andme-and-udacity-launch-massive-online-open-course-in-human-genetics-115


In the second half of 2013, for example, 23andMe.com initiated a business campaign to position itself as a source of on-line information about genetics for educational purposes....Its partner in this effort is Udacity, another Silicon Valley company. It was last September with the two companies announced that they would collaborate in the fast-growing trend of “massive open online courses” (MOOCS). ... 23andMe.com and Udacity hope to reach exponential numbers of students—and potential customers for 23andMe.com. The two companies, both based in Mountain View, California, are collaborating to offer a MOOC on introductory human genetics, according to a 23andMe press release posted on The Wall Street Journal’s MarketWatch.com. MOOCs are an emerging educational technology used for distance learning.

Jean M
02-05-2014, 05:32 PM
Direct-to-Consumer Testing’s Constitutional Appeal
http://www.genengnews.com/insight-and-intelligence/direct-to-consumer-testing-s-constitutional-appeal/77900031/


The First Amendment may not protect someone yelling “Fire!” in a crowded theater, but should shield 23andMe and other direct-to-consumer (DTC) genetic testing companies from “overcautious” FDA regulation, two longtime supporters of test providers argue, reopening the debate over agency dealings with the company.

Robert C. Green, Ph.D., and Nita A. Farahany, Ph.D., J.D., urged FDA to avoid restricting consumer genomic testing “unless faced with empirical evidence of harm.” They cited two cases where courts used free-speech protection to overturn a law curbing the use of doctors’ prescription records, and a doctor’s conviction for promoting off-label drug use...

The co-authors’ arguments, published in Nature, come about two months after FDA ordered 23andMe to stop selling its Saliva Collection Kit and Personal Genome Service (PGS), and obtain agency approval to market the $99 “spit kit.” The company still provides consumers ancestry-related information and raw genetic data without interpretation, uses its database of genetic and phenotypic data in research, and maintains educational efforts....

Drs. Green and Farahany cited several studies concluding that DTC testing results had not plunged large percentages of customers into despair or panicked them to visit their doctors.

MikeWhalen
02-05-2014, 06:06 PM
bu-bye, bu bye

does anyone remember the old phrase?
"dont go away mad, just go away"

:)

M


Your warning is unwarranted.
I am attacking no one.
Everything contained in my post is a fact.

Please feel free to delete anything that I have posted that you find offending.

Goodbye Anthrogenica!

Joe B
03-02-2014, 04:34 AM
First updates to the 23andme Health and Traits report since last November. Gaucher Disease and Cystic Fibrosis were updated for the same reason, "quality review processes determined that genotyping data for this marker may not be reliable."
Wonder if this is part of the process to become FDA compliant or just ongoing quality review processes.
Either way, it's good to see.

Cystic Fibrosis
Two markers have been removed from this report. i4000319 (corresponding to 2184delA) and i4000323 (corresponding to 3876delA) have been removed because our ongoing quality review processes determined that genotyping accuracy for these markers no longer meets our stringent quality criteria.
As a result of this update, some customers who previously had a "Variant Present" result will now see "Variant Absent" for this report.

Joe B
03-15-2014, 06:15 PM
Anne Wojcicki was giving interviews at the SXSW Interactive festival in Austin last week. Here is one from VentureBeat.
23andMe CEO: ‘We need to return to delivering health information’
http://venturebeat.com/2014/03/12/23andme-ceo-we-need-to-return-to-delivering-health-information/

VentureBeat: Government agencies like the FDA move at a notoriously glacial pace. Is that frustrating for an entrepreneur?
Wojcicki: They have been a good partner to us in that sense. If we send them something on Friday, I’ll get a call on Monday. They have been responsive. But it’s still unclear how our test fits into the current guidelines.
That made me laugh.

Jean M
05-14-2014, 05:10 PM
The FDA can't stop 23andMe from operating outside the US. Not that 23andMe will get tossed out of the US without a struggle, but I dare say that if they have to move to Canada they will.

The FDA won't let 23andMe test your genes — so it may go to Europe
http://www.vox.com/2014/5/12/5709766/the-fda-wont-let-23andme-test-your-genes-so-it-may-go-to-europe

The personal genetics startup 23andMe may start selling its products abroad after facing barriers with US regulators.

According to Reuters, a company spokesperson confirmed that 23andMe was "evaluating international opportunities." An unidentified anonymous source told Reuters that the company is planning to enter foreign markets by the end of the year.

R.Rocca
05-14-2014, 05:24 PM
The FDA won't let 23andMe test your genes — so it may go to Europe
http://www.vox.com/2014/5/12/5709766/the-fda-wont-let-23andme-test-your-genes-so-it-may-go-to-europe

The personal genetics startup 23andMe may start selling its products abroad after facing barriers with US regulators.

According to Reuters, a company spokesperson confirmed that 23andMe was "evaluating international opportunities." An unidentified anonymous source told Reuters that the company is planning to enter foreign markets by the end of the year.

Let's hope that they get back to delivering health information. Hopefully the next time around their lawyers will put enough disclaimers to keep 23andMe operating for a long time.

vettor
05-14-2014, 06:26 PM
The FDA won't let 23andMe test your genes — so it may go to Europe
http://www.vox.com/2014/5/12/5709766/the-fda-wont-let-23andme-test-your-genes-so-it-may-go-to-europe

The personal genetics startup 23andMe may start selling its products abroad after facing barriers with US regulators.

According to Reuters, a company spokesperson confirmed that 23andMe was "evaluating international opportunities." An unidentified anonymous source told Reuters that the company is planning to enter foreign markets by the end of the year.

Most likely they will go to Ireland like very many other American companies ..............cheap corporate taxes.

It will be a good thing getting away from the ultra americanization of 23andme

Táltos
05-14-2014, 06:35 PM
Let's hope that they get back to delivering health information. Hopefully the next time around their lawyers will put enough disclaimers to keep 23andMe operating for a long time.
Perhaps they will charge a fee if you want your kit upgraded from the Ancestry only.

Táltos
05-14-2014, 06:40 PM
Most likely they will go to Ireland like very many other American companies ..............cheap corporate taxes.

It will be a good thing getting away from the ultra americanization of 23andme

Ireland is a beautiful country!

Not sure what you mean by ultra americanization though, the founders of 23andme are American after all. :) Now if you mean American government= over reach, over step, not what I think our Founding Fathers intended. I agree!

vettor
05-14-2014, 07:44 PM
Ireland is a beautiful country!

Not sure what you mean by ultra americanization though, the founders of 23andme are American after all. :) Now if you mean American government= over reach, over step, not what I think our Founding Fathers intended. I agree!

the rhetoric I get is that they are not interested in Europeans who never migrated to America, but are very interested on Europeans who are Americans ...........my opinion after a plus year of being a member

Jean M
05-14-2014, 08:09 PM
More details from Reuters. I should have looked there right away.


May 6 (Reuters) - Home genetics startup 23andme is forging ahead with plans to sell its full-fledged test kit - just not in the United States.

The Google Inc -backed firm is moving to English-speaking markets abroad after facing hurdles from the U.S. Food and Drug Administration, according to one person with knowledge of its plans.

Late last year, the company agreed to stop selling its $99 DNA test until it obtained marketing authorization from the FDA. In a public warning letter, the FDA said it feared false positive or false negative results from 23andme's genetic test could prompt patients to take "morbidity inducing" actions, like unnecessary surgery.

Now, 23andme has formed a team internally to explore the path to approval overseas, the person with knowledge of the company, who asked not to be named, told Reuters...

While it awaits the agency's approval, a process that could take years, 23andMe aims to offer partial or full genetic-testing services in one or more countries outside of the United States by the end of the year, with likely contenders including Canada, Australia and the United Kingdom, the source said.

Jean M
06-01-2014, 11:52 AM
Anne Wojcicki discusses future of 23andMe
http://www.sfgate.com/technology/article/Anne-Wojcicki-discusses-future-of-23andMe-5502875.php


Q: Is it true you're planning to seek approval for 23andMe abroad? (The company sells an abridged version of its test in more than a dozen countries, and news reports say that it is exploring partial or full approval for its health kits overseas.)

A: We haven't confirmed any one way or another, but we want to continue operating all over the world. So we'll see where makes the most sense.