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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 clovell on 5/13/2010 5:10:30 PM , Rating: 2
Freedom? Freedom to sell a 'diagnostic test' without meeting any burden of proof required to show its accuracy & specificity?

You think that's characteristic of a 'nanny-state'? Let me ask you - and you, as well, porkpie - how much do you know about genetic sequencing and testing? How about its relation to Alzheimer's Disease? Huntington's? How about incidence, prevalence, stability, and good manufacturing processes?

Now, take that and extrapolate what the average consumer probably knows about that stuff - because I know you're both intelligent. Diagnostic products fall under the purview and charter of the FDA. This is exactly their job.

I can't imagine the amount of hell that would ensue if insurance companies were able to start jacking up rates or denying coverage based on results from these kits or any toher unvalidated test.

Every company that develops diagnostic equipment knows the the development cycle. It's been in place for decades. Where was the 'nanny-state' FDA during the 80s & 90s? Where was it ~10 years ago during the Vioxx debacle? I guess my mindset just isn't THAT Libertarian, because I don't see a problem here at all.


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