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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 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
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.

"It's okay. The scenarios aren't that clear. But it's good looking. [Steve Jobs] does good design, and [the iPad] is absolutely a good example of that." -- Bill Gates on the Apple iPad

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