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Pathway Genomics is looking to sell a variety of gene tests to the public via retailer Walgreens. The FDA may block sales, though.  (Source: Pathway Genomics)
Tests are going to be sold at 6,000 of Walgreens' 7,500 stores

Want to know if you will get breast cancer, Alzheimer’s disease, become obese, or suffer from a range of other maladies?  It's all in your genes.  

Currently you would have to go to doctors to test for genetic abnormalities that could lead to various illnesses.  An enterprising San Diego startup called Pathway Genomics has compiled a variety of these tests, though, and is about to start selling them at retail giant Walgreen.

FDA spokeswoman Karen Riley was surprised by the news and said that the company has not yet received approval for the devices and must first get approved.  Approval would involve a lengthy and expensive process of submitting evidence of the device's efficacy and could shelve the retail plans for years.  However, if the company does not comply, Riley warns that the FDA may order the devices pulled from Walgreens' store shelves.

Gene testing has to date exclusively been conducted in the medical setting.  The new Walgreen test, though, allows buyers to take a saliva sample and then send it back to the lab for analysis.  The company say that the results can help people make informed medical decisions.

The kits are set to go on sale at 6,000 of Walgreens' 7,500 stores.  Individual gene tests will retail between $19.99 and $30.  Combo tests are also available such as the drug-response test for $79, the "pre-pregnancy planning" test for $179, and the health condition test for $179.  All three of the combo tests are available for $249.

FDA's Riley warns, "The claims have limitations based on existing science, and consumers should not be making important medical and lifestyle decisions based on these tests without first consulting a health-care professional."

Jim Plante, CEO of Pathway Genomics refutes that his company has done anything wrong, stating, "There are people who need or want to know more about their genetic makeup, and we recognize that, for some, genetic reports are becoming a more important component in managing their personal health care.  The value of knowing how genes play a role in our personal lives, and potentially the lives of our children, is critical for making well-informed health and wellness decisions."

Ed MacBean, vice president of product development for the company says that his firm will "be happy to share with the FDA any data that is requested", but that, "We’re still going to sell the kits at Walgreens because at this point, we're not aware of any reason we are unable to."

The FDA according to a report in 
The Sun Times may also be considering action against online retailers of the test kits.  While Walgreens is the first brick-and-mortar retailer to offer the kits, they've been available previously online.



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By AEvangel on 5/13/2010 11:42:58 AM , Rating: 3
quote:
I agree that FDA is needed and is a good way to prevent snake-oil products or even damaging products from cheating consumers out of money or health. Sometimes it is better to be late than getting it early and being screwed for rest of the life.


You must not watch TV and the tons of Attorney's who have ads asking people to call who have used FDA approved drugs and then found out they have all these side effects.

Please the FDA is a joke and has been for years. The idea that they really care or do anything to protect us is laughable at best. The only thing that really protects us from your so called "Snake oil Salesmen" is the fear of a law suits by a damaged or mislead public.


By AssBall on 5/13/2010 12:32:16 PM , Rating: 3
The FDA is a joke. It takes them several years and millions of dollars to apporve even the most well researched and simplist drugs. Bureaucratic B.S.


By AEvangel on 5/13/2010 12:49:58 PM , Rating: 3
Or they Ban they ban medicine or medical procedures due to political pressure and not because it poses any actual health risk.


By Proxes on 5/13/2010 1:27:59 PM , Rating: 3
Or they want to ban the electronic cigarettes because they have chemicals that aren't good for you.

Orly? Why don't you ban real cigarettes then?


By digitalreflex on 5/13/2010 3:04:09 PM , Rating: 3
quote:
Orly? Why don't you ban real cigarettes then?

because of the $$$ they bring in


By BansheeX on 5/13/2010 10:52:31 PM , Rating: 2
Perfect example is Stevia. Not a medicine, but a natural (patentless) no-calorie sweetener banned in the 80s because domestic companies with patents on chemicals like aspartame stood to lose billions. There were actually FDA members who left to become executives at these companies after the fact. Really crooked stuff, especially when you think about all the health issues aspartame has caused. Aspartame remains the all-time number 1 complaint generator for FDA approved food items.


By clovell on 5/13/2010 5:16:34 PM , Rating: 3
Clinical effects of even the most simple compounds are still very complex and take a lot of time to research. Review of New Drug Applications typically takes 10 months. The rest of the development process is spent collecting necessary data and performing experiments by each company. This is the part that takes years, more often than not.


By clovell on 5/13/2010 5:12:38 PM , Rating: 2
The FDA does a lot of good work, dude. I can base this on more than watching daytime TV ads. Lawsuits didn't stop Merck & Vioxx; the FDA did.

Nice try, though.


By Reclaimer77 on 5/13/2010 5:17:01 PM , Rating: 1
Umm but the FDA also approved the drugs in the first place. Stopping bad drugs BEFORE they get to the consumer is their job, right?


By clovell on 5/13/2010 5:22:25 PM , Rating: 3
Yes, it is. Unfortunately they screw up sometimes, but there's a lot more stuff that they catch than stuff that gets through, at least in terms of pharmaceuticals. As for Vioxx, a lot of that stuff was covered up / omitted and not reported to the agency.

They're far from perfect, but they still do a service to the citizens of this country and are far from the waste of breath & money that some folks seem to regard them as.


By dagamer34 on 5/14/2010 12:10:26 AM , Rating: 3
Some drugs don't show their side effects in any statistically significant way until it's out on the market. If you wanted to have a drug that had NO side effects, well... it just hasn't been invented yet (and almost certainly never will).

As much as people want to bash on the FDA, the fact that you don't have widespread pandemonium from people taking their meds means they are doing their job. Believe me, it would be MUCH worse if they weren't around. Don't take what you have for granted. That's the simplest mistake any person can make about anything.


By tastyratz on 5/14/2010 11:08:23 AM , Rating: 2
yup... prettymuch.
Cant have your cake and eat it too. People bitch about long term side effects then bitch about how long it takes to get a drug to market through all the red tape. Well the red tape is there for a reason and they should have to take the long hard road.

It is completely impossible to predetermine long term and many significant side effects not experienced in large pilot groups while keeping modern medicine unrestricted. Its a balance, and I think in general the FDA does it pretty well. Every once in awhile unforeseen circumstances beyond reasonable and thorough testing arise and eventually get squelched... but you cant see it all.

Anytime you have a problem with corruption its large government and man that's the problem, not the agency. No matter where you go you will find someone who will turn a blind eye with a greased pocket. Drug companies are big business.


By AEvangel on 5/14/2010 3:39:38 PM , Rating: 1
quote:
The FDA does a lot of good work, dude. I can base this on more than watching daytime TV ads. Lawsuits didn't stop Merck & Vioxx; the FDA did.


quote:
"In 2005, advisory panels in both the U.S. and Canada encouraged the return of rofecoxib to the market, stating that rofecoxib's benefits outweighed the risks for some patients. The FDA advisory panel voted 17-15 to allow the drug to return to the market despite being found to increase heart risk."


http://en.wikipedia.org/wiki/Rofecoxib#Withdrawal

The below article was written in 2004.

quote:
"Merck & Co.'s arthritis drug Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before it was pulled from the market last week, the Wall Street Journal reported Wednesday, citing an unreleased study by government regulators."


http://www.msnbc.msn.com/id/6192603/

Yeah allot of good they did they not allowed the drug to be re-released but kept the study that showed it was killing people unreleased from the public.

Your going to need a better example of how the FDA is helping us cause Vioxx is a prime example of how it part of the same huge corrupt Fascist system that exist all over Washington.


By Staples on 5/14/2010 11:48:47 AM , Rating: 2
I'd rather have the FDA than nothing.
And I am worried that you believe these ambulance chaser commercials on TV. Must have never hear of frivolous lawsuits.


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