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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 therealnickdanger on 5/13/2010 11:39:53 AM , Rating: 4
The FDA used to do its job and do it well, but now it's just one more bloated government entity run by lobbyists and supposedly "ex" corporate lawyers aiding the expansion of legal power and patent dominance of their former employers.

As I see it, there are already 1,000 commercials per day about "HD Eagle Eye Sunglasses" that improve vision, "Magentic Healing Bracelets" that improve your golf swing (and your entire life), "Fat-busting Supplements" that make you skinny (only if you are extremely overweight), "pills that make that certain part of the male body bigger", etc. There are tons of products out there designed and marketed to do things that they simply do not do, despite the testimonials and touted sales numbers. (Although it is comforting to know that 5 billion worthless capsules of PEN-15 Club GrowthMaxx+ have been sold to countless idiots.)

Here's a DNA test that may or may not have any more credibility than a BMI test... what does the FDA care? Thanks to Sen. Hatch and his pals, vitamin supplements are no longer regulated, so why should millions of tons of ingested chemicals be allowed to proliferate while a benign test is blocked? Are they truly protecting the interests of consumers in this case? Or are they simply trying to keep these tests in the government-only-certified medical arena at the behest of AMA lobbyists?

This test could be bogus, but the FDA is almost assuredly bogus. In either case, the FDA should probably stick to preventing more embarrassing E. coli outbreaks.

One more thing: the article is wrong, it's not Wal-Mart, it's Walgreens.


"When an individual makes a copy of a song for himself, I suppose we can say he stole a song." -- Sony BMG attorney Jennifer Pariser














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