https://mobile.nytimes.com/2017/04/06/health/fda-genetic-tests-23andme.html
For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood that they could develop various conditions, including Parkinson's and Alzheimer's.
The move on Thursday is a turnaround for the agency, which had imposed a moratorium in 2013 on disease tests sold by the company, 23andMe, which is based in Mountain View, Calif. The decision is expected to open the floodgates for more direct-to-consumer tests for disease risks, drawing a road map for other companies to do the same thing.
If you could take such a test, would you? Or would you rather just take things as they come?
Related Stories
The FDA will allow the genetic testing company 23andMe to offer information about three common BRCA mutations that can have an influence on breast cancer risk. According to the FDA, the test should not be used as a substitute for seeing a doctor:
The Food and Drug Administration for the first time has authorized a genetic testing company to offer screenings for three breast cancer mutations common in Ashkenazi Jews, giving consumers the ability to initiate testing at home and see results without talking to a doctor or counselor.
The agency's action on Tuesday permits the testing company, 23andMe, to report results as part of its $199 Health and Ancestry product, which uses DNA from saliva samples to inform customers about their families' countries of origin, along with information on genetic health risks. There will be no extra charge for the additional reports, which should be available in a few weeks to customers who actively opt in and request to see them, company officials said.
[...] But testing negative for the three mutations does not mean someone is in the clear, as there are over a thousand BRCA mutations associated with increased cancer risk. Some critics say that comprehensive genetic testing — an exhaustive analysis to detect all mutations associated with an increase in breast cancer risk — is preferable. Physicians, geneticists and policymakers have long been concerned that the enthusiasm over personalized medical information and genetic testing may place consumers who misunderstand or misinterpret results at risk of jeopardizing their health. Even for Jews of Ashkenazi descent, whose families originated in Eastern and Central Europe and who are most likely to test positive for the three mutations, testing negative is no panacea, as they may carry other mutations that increase cancer risk.
Also at STAT News, Reuters, and The Verge.
Related: FDA Permits Marketing of 23andMe Direct-to-Consumer Genetic Test
Color Genomics Launches a $249 Genetic Test for Breast Cancer Risk
23andMe Genetic Test Relaunches, but Transparency Report Reveals Law Enforcement Data Requests
FDA to Allow 23andMe to Sell Genetic Tests for Disease Risks
(Score: 5, Insightful) by KilroySmith on Sunday April 09 2017, @01:27AM (8 children)
If a single $1000 test would tell me the diseases that I'm genetically predisposed to, I'd pay for it in a second. Who cares if I'm at risk for cardiovascular disease, or diabetes, or whatever - knowledge is power. I now know specific diseases that I and my doctor can look specifically for symptoms of.
I won't do it, though. I refuse to pay 23andMe $1000, and also give them full rights to any information they can mine from it. Perhaps in 10 years, insurance companies pay 23andMe to rank people by life insurance risk - no personally identifiable medical information is disclosed, but all of a sudden life insurance, or health insurance, are unavailable to me at any price because 23andMe rates me a "low" on an insurability scale.
(Score: 3, Insightful) by mhajicek on Sunday April 09 2017, @02:20AM
gattaca
The spacelike surfaces of time foliations can have a cusp at the surface of discontinuity. - P. Hajicek
(Score: 2) by gringer on Sunday April 09 2017, @02:38AM
If you don't mind a $2000 cost, you can do that yourself with the MinION (assuming you have access to pipettes and minicentrifuges).
If you can find another 11 like-minded people, you can split the sequencing 12 ways with a barcoding kit, and reduce the consumable cost to about $200 per person. Coverage would be lower, but will be sufficient to pick up a few structural variants and maybe a few at the sequence level as well.
Ask me about Sequencing DNA in front of Linus Torvalds [youtube.com]
(Score: 3, Informative) by FlatPepsi on Sunday April 09 2017, @03:37AM (3 children)
You do know that your prices are an order of magnitude off, right?
I had my DNA run for $199. It wasn't that long ago it was $99.
So far 23amdMe seems to be eager to share with customers their data (I can even do a full ZIP download for processing by 3rd parties), and I've seen no evidence of abuse with 3rd party sharing.
(Score: 2) by takyon on Sunday April 09 2017, @04:09AM
You had your DNA "run", but you didn't get your full genome for $199. If you get a cheap test from 23andMe, you are getting some partial analysis of whatever they think is important today. Get your full sequence discretely and maybe you can analyze it yourself using free software years in the future. If you're lucky, your sequence won't make it back to the FBI or insurance company (permanently).
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by KilroySmith on Sunday April 09 2017, @04:09AM
Sure - but they aren't offering screening for particular diseases at the moment. Presuming they get to the point of offering screening for a number of different possibilities, at $20 a pop, several hundred additional dollars are still likely. Still well below my statement, but I still hate paying for something and finding out they're selling all my data behind my back (see: TurboTax).
The fact that you haven't seen any evidence of abuse, doesn't mean squat. Your data belongs to them for all time - a quick sell-out to an insurance firm, and it's all over. Have you ever read their data privacy policy? Could you understand it? Did it clearly prohibit the scenario I gave above? If not, your genome no longer belongs to you.
I am absolutely thrilled by the possibilities that genetic testing opens up. I'm absolutely horrified by the possibilitie that genetic testing opens up also.
(Score: 2) by linkdude64 on Sunday April 09 2017, @03:06PM
Way to completely miss the entire point of his comment.
(Score: 3, Interesting) by frojack on Sunday April 09 2017, @04:02AM
Watch this kind of thing become a common Pre-Nup requirement.
Especially if one party had a recessive gene for something, and wanted to be sure only one of them did.
No, you are mistaken. I've always had this sig.
(Score: 2) by Anne Nonymous on Sunday April 09 2017, @02:16PM
23andme is the Name-A-Star of genetic testing.
(Score: 1, Insightful) by Anonymous Coward on Sunday April 09 2017, @01:56AM (10 children)
I agree with the position of the commenter above.
Unless it is possible to take the test as "John Doe" and receive the results
via an anonymous remailer service, no way I'd risk becoming a "known higher risk"
person. Not only could coverage be denied, but premiums could skyrocket and that
alone could make insurance untenable. Spare me any bullshit about "Obamacare",
it wasn't some sort of wonderful deal, it's just a NEW TAX, and anyone who isn't
an idiot understands this.
(Score: 4, Insightful) by Runaway1956 on Sunday April 09 2017, @02:59AM (6 children)
But, I'm going to Obamacare Romneycare and Hillarycare you anyway.
The insurance companies shouldn't BE able to pick and choose. When they started their industry long ago, insurance was a gamble. Despite their actuary tables and various other risk tables, the insurance company had no idea WHO might be the short lived and who might be the long lived customer. Providing insurance was a gamble, and they stacked the odds as best they could in their favor.
DNA tests promises to remove many of the risks, and help to insure the profits. Not for you or me, but for the insurance companies. Consequently, the insurance companies are going to drive the next eugenics wave. Which might not be all bad, except, few of us are likely to agree with the insurance companies about "desirable" traits.
Although Obamacare was a total flop, there were a couple good things in it. Forbidding insurance companies from rejecting you due to pre-existing conditions was one of those good things. People need more protections from arbitrary decisions made by the insurance companies.
Of course, if we start down that road, I'll soon be explaining why I think the insurance companies should all be reworked, from top to bottom - then be forbidden from ever lobbying at the capitals again. You owe a lot to insurance companies, and it isn't all good.
(Score: 0, Troll) by Ethanol-fueled on Sunday April 09 2017, @03:39AM (3 children)
I bet American medical insurance would be a hell of a lot better if we kicked out all the illegals with 9 illegitimate babies each, illegals with smallpox and zika, and eliminate handouts for the elderly who could otherwise afford to pay for whatever treatments they need.
But where would the Democrats get their votes?
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @04:27AM
The elderly? Vote Democrat??? lol
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @04:28AM
Or if we kicked all those chain-smoking lardasses that constitute the GOP out and made them cover the costs themselves. It's astonishing how fat those fat fucks in red states are.
Here's a hint, chipmunk cheeks are not actually attractive. Get your fat asses in a gym every once in a while.
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @02:19PM
I'm an elderly, illegal, illegitimate baby, and I voted Republican nine times this past election.
(Score: 0) by Anonymous Coward on Monday April 10 2017, @03:34PM (1 child)
Yes, but consider this: if insurance companies eliminate the source of risk completely, they have no business model any more.
They may make a sure buck by not insuring high risk clients, but if I find out I have a low risk, I won't need them!
(Score: 2) by Runaway1956 on Monday April 10 2017, @05:09PM
There are still accidents, and communicable diseases. So - you're immune to cancer, diabetes, and alzheimer's, and very low risk for another half dozen diseases and conditions. Along comes rubella, and it really kicks the shit out of you. Or, you travel to Fuckistan, and despite all the prophylactic measures, you get malaria. At age 20, the insurance companies loved you - at age 23, you're untouchable. Sux2BU, huh?
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @06:31AM (1 child)
I want to have somebody -- perhaps not me -- walk into a Walmart or Walgreens or CVS to buy the kit with cash. I then use it and send it off, retaining a card with an unguessable URL and password. Weeks later, I use borrowed WiFi to fetch my results.
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @06:59AM
I want to steal DNA from famous people, and later publish their full genomes. Using a third party service is a crutch.
(Score: 2) by gidds on Wednesday April 12 2017, @07:58AM
This is your genome. With it, it should be possible to tell almost exactly what you look like — your face, your height and build, your skin colour and hair colour, &c. (If not now, then before too long.) It may even be possible to estimate your age from your telomeres, make a guess at your location from demographic data, &c.
So while it may be technically anonymous, it's still handing them far more than they need to identify you, pick you out of a crowd or CCTV footage, or go to law-enforcement for a match. So it's pretty far from ‘absolute’ anonymity.
[sig redacted]
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @02:19AM (1 child)
This bad until privacy limits Are imposed. This will be a third party with info so privacy for you. Or must file with insurance companies. You know if you fail an aids test a perminatr flag is against your name in a insurance owned registers?
It also why you need to stay away from ansistery com too
(Score: 2) by frojack on Sunday April 09 2017, @04:26AM
It also why you need to stay away from ancestry com too
Problem with that is all it takes is one curious relative to submit to the Ancestry dot com for everybody of even the remotest kinship to be doxed.
For the most part Ancestry.com started out as a Mormon thing. [wikipedia.org] They have always been creepily interested in mapping lineage. So much so that in the 80s they were making proposals to state governments to take over all Birth and Death registrations state wide for free if they could retain a copy of the data. I don't know if any states besides Utah went for that.
Now days Premera (health care) owns a 30% share.
So yeah, the less they know the better.
No, you are mistaken. I've always had this sig.
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @02:41AM
Pay for the test then pay more for insurance after they sell your information, sounds like a deal to me!
Why didn't trump just press the button and save us all a lot of grief?
(Score: 4, Informative) by quixote on Sunday April 09 2017, @03:55PM (1 child)
At the end of the post: "If you could take such a test, would you? Or would you rather just take things as they come?" That assumes the tests gives us usable information.
As a college bio prof using molecular tools in my research, I want to shout about the big technical problem with this.
The diseases of interest to people are multifactorial. Science has barely identified a few of the factors for most conditions. So we really don't know which genetic patterns to look for with a high degree of confidence.
Plus -- huge additional issue -- all these genetic patterns are statistically associated with given conditions. So, if the total population has a 1% risk of developing purple hair after age 40, and your genetic data indicates a 10% risk, yes, your risk is higher but it's still very far from a sure thing. And since many factors are involved, eating kale to reduce your risk may or may not actually alter it.
tl:dr; Science doesn't know enough for these tests to be useful to people without way more training in medicine, biology, and statistics than most people (or insurance agencies) have.
The other issues commenters have mentioned, privacy, insurance problems, are even bigger.
(Score: 0) by Anonymous Coward on Sunday April 09 2017, @04:27PM
if the total population has a 1% risk of developing purple hair after age 40, and your genetic data indicates a 10% risk, yes, your risk is higher but it's still very far from a sure thing.
Nothing is certain in life, taxes and death notwithstanding. Still, knowing you have a higher chance of X can be useful. You can for instance avoid things that increase the chance of X.
To some degree this is already done. Some families have high incidence of heart disease for instance. It isn't a sure thing, but ignoring the numbers because it isn't a 100% certain thing is foolish.
(Score: 2) by Kilo110 on Monday April 10 2017, @02:01AM
I often hear their commercials on the radio. It's usually some woman blathering on about her test results and sharing such "deep" insights from her results like she's "predisposed to liking coffee".
I honestly thought they were spoofs put up by competitors, but no, they're genuinely proud of their tests...