Genetic Testing Coming To a Drugstore Near You

Hugh Pickens writes "The Chicago Sun-Times reports that Walgreens is slated to begin selling genetic-testing kits priced from $20 to $30 apiece that can tell people whether they're likely to get breast cancer, Alzheimer's disease, become obese, or suffer from a range of other maladies. However, to get the results of various tests, shoppers will have to fork over an additional $79 for drug-response results, $179 for 'pre-pregnancy planning' results, $179 for health condition results, or $249 for a combination of the three. Pathway Genomics and other companies already offer such tests online, but Walgreens will be the first brick-and-mortar retailer to sell them. FDA spokeswoman Karen Riley says Pathway overstepped its bounds when it announced its plans to market the tests directly to the consumer at 6,000 of Walgreen's 7,500 stores and wants Pathway Genomics to submit data showing that its tests give accurate results. 'The claims have limitations based on existing science,' says Riley, 'and consumers should not be making important medical and lifestyle decisions based on these tests without first consulting a health-care professional.' Walgreen responded that FDA clearance is not required to sell the kit in its stores; and anyway, the drugstore chain already sells other diagnostic and testing products such as pregnancy tests, paternity tests, and drug tests."

Pathway Genomics Agreement

[eldavojohn]

Here's some required reading [pathway.com] if you are contemplating this. Most importantly:

5. Services Limitations. The Services provided by Pathway Genomics are solely for research and educational purposes and uses. Although based on scientific research, the Services, including all information about genetic findings and probabilities, have not been fully validated and shall not be relied upon by you or any other person to diagnose, treat or prevent any disease or health condition. You should consult with a physician or other appropriate health care professional regarding the diagnosis, treatment and prevention of any disease or health condition.

Emphasis mine. I knew that'd be in there along with point 13 (the indemnity clause). On the plus side they've got this:

9. Proprietary Rights. You own all Genetic Information derived from your saliva or other biological material. Genetic Information means the As, Ts, Cs, and Gs at particular locations in your genome.

If you submit or post content on the Pathway Genomics website or otherwise using the Services, (a) you retain any copyright rights that you hold in this content, and (b) you grant Pathway Genomics a nonexclusive, perpetual, irrevocable, royalty-free, worldwide license to copy, modify, translate, publicly display and distribute this content. This license grants Pathway Genomics the right to use this content to provide the Services and to provide this content to other companies and individuals affiliated with Pathway Genomics. You warrant to Pathway Genomics that you have the right, power and authority to grant this license.

Of course we all would think that would go without saying but you never know these days and in bullet 12 they follow that up with you have permission to send them this sample. I shudder to think that someone might grab some of their significant other's saliva in order to see what their genetic tests reveal and call the whole thing off based on the fact that their offspring would have a 5% higher chance of getting breast cancer according to The Super Deluxe Cancer Finder 3000.

Re:people never change

[fuzzyfuzzyfungus]

The question, of course, is to what degree lifestyle is influenced by genetic factors...

Unless we are going to cling to the (intuitively satisfying; but rather silly) theory that humans have some sort of extra-material "free will" floating around in the aether, we pretty much have to concede that behavior has a biological basis. And, if something has a biological basis, the odds of it having a genetic and/or epigenetic component are pretty decent.

Re:Pathway Genomics Agreement

[L4t3r4lu5]

HIV can be transmitted by saliva, but the virus isn't typically concentrated there to the same degree as sexual fluids, or the bloodstream. Anecdotally (from my Biology teacher at school), it was guessed at around one litre of saliva would have to be ingested to pose a serious risk of infection.

Re:Could be worse

[AndersOSU]

There are laws against using genetic information for hiring/firing decisions and health insurance purposes.

Laws aren't perfect, so it's conceivable and perhaps even probable that a few people will be negatively impacted by insufficiently private genetic testing, but systematic abuse of this kind of information opens you up to law suits that are far more serious than slightly elevated group insurance rates.

This is BS Voodoo

[quixote9]

Scientists don't know yet which genes in which combinations cause Alzheimers or heart disease or cancer. (Trust me. This type of thing was my job.) All scientists know at this point is a few genes which are associated with chronic diseases.

You'd have a better chance of a true prediction of your fate using astrology. We don't know enough to make a yes/no test for those diseases. We do know enough to make a yes/no test for pregnancy or drugs. (Actually, not always on the latter. Don't eat any poppy seed buns the day before.)

The difference between a drugstore test and a doctor's is that there is some chance the doctor will be aware of the complexity, of what the testing cannot do, and of how much it really means for your future.

The drugstore test is just a way to take your money.

Re:Pathway Genomics Agreement

[Anonymous Coward]

"Contact with saliva, tears, or sweat has never been shown to result in transmission of HIV."

From:
http://cdc.gov/hiv/resources/factsheets/transmission.htm

Here's the catch

[nbauman]

there is a way that is cheaper and more effective.

Family history.

With the exception of (not-nonexistent; but quite rare) conditions caused by a mutation or mutations that originated with you, not earlier in the line, or a fairly small number of well developed genetic tests, most of which you aren't going to get over the counter at CVS, you'll have a better chance of learning about the likely phenotypic consequences of your genes by looking at mommy and daddy

You are correct.

I just went through a stack of articles on this so let me see if I got it right.

There are two kinds of genetic diseases.

First there are the extremely rare diseases which are caused by a single mutation, like Gaucher disease. If it was in your family, you'd almost certainly know it, or you'd at least know that you have a problem in your family, because you would have had relatives who had it. Like most of the rare diseases on that list http://www.pathway.com/more_info/full_list_of_conditions [pathway.com] (all of which you can look up in Wikipedia) it's a pretty dramatic disease.

One of them in the news lately was Charcot-Marie-Tooth disease, which is worth looking up http://www.nytimes.com/2010/03/11/health/research/11gene.html [nytimes.com] http://en.wikipedia.org/wiki/Charcot-Marie-Tooth_disease [wikipedia.org] just because it's so interesting.

Second there are the more common diseases like breast cancer, colorectal cancer, coronary artery disease, diabetes, etc., which most of us will die from.

There are a few single-gene mutations that will usually result in cancer, like the BRCA1 or BRCA2 gene for breast cancer, which occur in about 1 or 2% of the population.

But most of the other genes that are associated with those diseases only confer an additional 1% (or less) risk of the disease. That's the big frustration in genetic medicine. The doctor tells you, "You've got a genetic variation that, other things being equal, gives you a 1% increased risk of getting diabetes." How is that information going to change your life in any way?

Scientists think they're doing pretty well if they discover a gene that increases the risk of a common disease by 10%. Now 10% is the *relative* risk. If 5% of the population gets a particular disease, that gene will increase the risk to 5.5%, which is not much greater. So you've found out that you have an increase in the *absolute* risk of 0.5% from that one gene. (But you don't know anything about the dozens of genes affecting that disease that they haven't discovered yet.)

One of the problems with BRCA1 and BRCA2 is that those genes were patented by Myriad Genetics, which was charging $3,000 or more to test for that one gene. Many of the most important genes were patented, and one of the disadvantages of that was that it made it impossible to put together a cheap screen of all the common disease-associated mutations. Myriad just lost a patent lawsuit, and if that decision is upheld, we will be able to get genetic screens with every important known mutation. http://www.aclu.org/free-speech/brca-genes-and-patents [aclu.org] But I can't tell from Pathway's web site whether they include BRCA1 and BRCA2 screening in their test.

Another problem is that mutations are caused by a defect in DNA. There are lots of defects. The Pathway test may be testing for one breast cancer mutation, while you have a different mutation somewhere else along the DNA strand that gives a protein with a different but equally damaging defect.

Now that I look at it again, I see that they don't include Charcot-Marie-Tooth disease in their genetic screen. http://www.pathway.com/more_info/full_list_of_conditions [pathway.com] (Maybe that's

Re:Could be worse

[Idiomatick]

"The anti-discrimination authorities may get interested, if your old barber was Black, but the new one is White... "

I've been able to tell the difference between black and white folks without genetic testing for my whole life. But if I switched from a black barber to a white one I really doubt that the authorities would care.

I find it fascinating that the dsytopic future you warn against has already been proven not to pass. I'm sure you could have thought of some form of government control that actually happens. Sheesh.

Re:Pathway Genomics Agreement

[gstoddart]

Insurance companies, head hunting agencies, 3-letter government agencies, your employer, etc.

In short, anyone they choose to share it with .... nonexclusive, perpetual, irrevocable, royalty-free, worldwide license to copy, modify, translate, publicly display and distribute this content is pretty much everyone.