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Would You Buy an Over-the-Counter Genetics Test?

Posted June 16, 2010 4:00 AM by Sharkles

Last month, Walgreens, the largest drug store chain the United States, made news by announcing that it would sell over-the-counter (OTC) genetics testing kits in 6,000 of 7,500 stores across the country. These tests are made by Pathway Genomics, a start-up company from San Diego, California.

According to Pathway's website, the genetic testing kits can be used to screen for potential responses to medications, health conditions, ancestry, or in pre-pregnancy planning. The company's web site also features a complete list of the conditions that can be detected with Pathway's kits. By partnering with Walgreens, Pathway hoped to get ahead of its better-known rivals 23andMe and Navigenics who are working on similar screening kits.

On May 10th, Walgreens announced the sale of Pathway Genomics kits for a mere $20; however, the actual testing done by Pathway would cost anywhere from $79 to $249. Though the details were ironed-out, neither Walgreens nor Pathway notified the U.S. Food and Drug Administration (FDA) about their plan.

Rising Concerns
After learning of the partnership, the FDA immediately began investigating medical claims made by Pathway since the test had not been approved by any U.S. regulators. Despite claims from Pathway officials saying the tests "surely" meet approvals, the kits were widely disputed by scientists who were quick to point out that diseases like Alzheimers have no definitive test as there is yet to be a known cause.

Chicago Breaking Business quoted The National Society of Genetic Counselors, which warned that issuing such tests "increases the chance for misunderstanding or misinterpretation of results." Others echoed the concern that most diseases cannot be marked "yes" or "no". According to Peter Kraft, Deputy Director of the Program in Molecular and Genetic Epidemiology at Harvard School of Public Health, "The truth is, for most diseases, no one knows exactly why one person gets it and another does not."

Backing-Off
Once the FDA began investigating, Walgreens released a statement saying that it would not be moving forward with providing the Pathway kits. Walgreens' announcement was commended by Sharon Terry of the advocacy and research group Genetic Alliance, who said that Walgreens was clearly acting in the interest of its customers by postponing the distribution of the Pathway tests.

Results
Since the Walgreens/Pathway move to bring genetic testing to consumer markets, the FDA has been making moves to begin reviewing them. On June 12th, The San Francisco Chronicle reported that the agency has begun issuing regulatory letters, stating its intent to review personal genetics tests under the same process that is used for medical devices.

The letters indicate that the FDA will begin to crack down on companies marketing products that claim to predict inheritable diseases. "Premarket review of medical devices enables FDA to protect the public from medical products that may pose an unreasonable risk of harm," they write. "It is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations."

In the meantime, personal health and genetics testing will remain an open market. But if these kits were to become commercially available, would you trust them - or would you rely on your doctor instead?



Resources

Jones, Sandra M. and Bruce Jaspen. "Walgreens to Sell Genetics Tests, FDA Investigating." 11 May 2010. Web. 14 June 2010.
<http://www.chicagobreakingbusiness.com/2010/05/walgreens-to-sell-gene-testing-kits-1.html>

Larkin, Catherine. "FDA to Review Personal Gene-Testing Kits." The San Francisco Chronicle." 12 June 2010. Web. 14 June 2010.< http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/06/11/BUVB1DTQBJ.DTL>

Pollack, Andrew. "Start-Up May Sell Genetic Tests in Stores." The New York Times. 10 May 2010. Web. 14 June 2010. <http://www.nytimes.com/2010/05/11/health/11gene.html>

Stein, Rob. "Walgreens Won't Sell Over-the-Counter Genetic Test After FDA Raises Questions." 12 May 2010. Web. 14 June 2010.< http://www.washingtonpost.com/wp-dyn/content/article/2010/05/12/AR2010051205363.html>

http://www.pathway.com/index

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#1

Re: Would You Buy an Over-the-Counter Genetics Test?

06/16/2010 6:46 AM

No I wouldn't, but then I'm neither neurotic nor gullible . I am a tad hypochondriac (well whadda ya expect I'm male) and I worry enough anyway.
So that's still a no...
Anyway it prob don't work for cats
Del

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#2
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/16/2010 12:11 PM

I'm sure there is something available for cats, Del, since you can now determine what species are in your mixed-breed dog: http://cr4.globalspec.com/blogentry/6111

This testing (the human variety) raises mixed emotions in me. I have a chronic autoimmune disorder and there is some history of this in my family. I would be curious to know what shows up in my DNA - in addition to the laundry list of health problems other family members have had.

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#3
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/16/2010 12:42 PM

Sorry about your autoimune prob, but of course it raises the obvious dilemma, if you could tell a potential child had a 'problem' what would you do?
I sometime think ignorance is bliss.
I wouldn't want to be playing 'god' with my life or anyone elses.
What if you you could identify a gene which may increase your likelihood of contracting some disease...the whole thing's a nightmare.
Del

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#4
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/16/2010 1:26 PM

If I knew I had a lot of "bad genes", I probably wouldn't have kids of my own. I have been through a lot of things I wouldn't wish on an enemy, let alone a child.

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#5
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 12:07 AM

I wouldn't and for the same reason as you. But here's the thing, we don't really know very much about most diseases.

We simply can't say this gene does this and this gene does that it's not that simple(endless docos are perhaps to blame for overly simplifing the science so that the average lay person can understand)

Really it's not much better than educated guessing and I can see it causing more harm than good.

People are looking for the simple in a complicated world, personally I like it complicated but perhaps that's just me.

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#10
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 10:38 AM

What I understood from the article is that you buy a sample collector for $20 then send it in to be analyzed for the $79.

So a lab will do the actual testing and give you the results. It basically saves you a trip to the doctors or clinic.

I see it as a means of giving the government a DNA sample on you if thy haven't got one already.

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#6

Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 5:42 AM

I would be more interested in using the test to check my ancestry than for disease.

I'm supposed to be German & Hungarian but I'm sure there is a larger mix in my blood than that. My mom tried to trace the family tree the usual way through a paper trail and didn't get very far before a reaching a dead end. Our line just suddenly stops going back about 30 years before WW1. Maybe we're clones or were dropped here by aliens.

But as far as checking for disease. Genetics probably only plays a small part in if you get a particular disease or not. There are many other factors to consider. Life style, Environment, etc.

Then there is the issue of personal security with these test. Who has access and what happens if your insurance company gets a hold of the info. If your found to be genetically inclined for a disease will they drop your insurance or just raise your rates so high that you can't afford it.

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#11
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 11:47 AM

Our situation ran the other way, but, yep, it turns out we ARE German, 100%. But up till 400 years or so ago, we were in Germany (our spelling of the name, there are several), but no sign of us since that 400 years or so back. Turns out we all went to Holland, due to a pogrom in Germany against Mennonites. So, how did we get a Dutch spelling to our name? Glad you asked. We actually are Mennonites (I'm not, but the rest of the family tree is, by and large) who have cycled back and forth from the German Low Countries to Holland and return many times throughout history. In fact, 400 years before that last trip to Holland, we made the trip the other way. Before that, who knows? But the point is, DNA COULD determine our heritage. But what would it gain us? Probably not worth the effort. Its good enough for me to know that I, and my progeny, all three current generations, are American. Cause when you look at ANYONE now (probably even the Japanese, and THEY like to think intermixing never happened to them), its doubtful they are pure-blood anything. Too much history of all being fair in Love AND War, so too much inter-mingling (or not too much, if you aren't somewhat bigoted about it. Miscegenation is still in the dictionary, but personally I couldn't care less!) has gone by for anyone to be able to "claim purity" (Aryan Brotherhood, anyone?)

I'll pass on this test.

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#12
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Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 1:26 PM

I'm Turkish Van with a bit of Persian...I think there is some Snow Leopard waaaay back.
Del

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#7

Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 7:48 AM

I remember a friend I worked with in Argentina - He had no interest in being tested for chagas disease (a parasite that Darwin may have died of). His sister had been but as there was no cure - what to do? Better to be left in the dark about some things.

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#8

Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 8:28 AM

I worry more about businesses getting hold of these kits and mandating their employees and applicants use them, then determine if the employee or applicant is a "long term health risk" to their insurance system.

Or, if you're self-employed and trying to get insurance...

There's already a big problem with pre-existing condition situations.

Lots of room for abuse, IMO.

Hooker

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#9

Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 10:29 AM

These tests can be both helpful, and can cause unnecessary worry, when people discover that they have genetic defects.

It is important to recognize that almost everyone in the human population is a recessive carrier of some genetic defect. It is for this reason that we do not allow marriage between brothers and sisters or close cousins. While gene testing is new, the knowledge of the higher risk of birth defects when close relatives marry is ancient. "No Body is Perfect," would be one way of saying it.

The value of the new testing tools is undeniable; how we use the new tools is a test of our human values in respecting human life.

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#13

Re: Would You Buy an Over-the-Counter Genetics Test?

06/17/2010 2:55 PM

Nope. I'm already 100% certain that my pets are people too. I have no need for a box to confirm it.

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