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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 MrBlastman on 5/13/2010 12:22:42 PM , Rating: 2
Just because the FDA reviews something doesn't mean you can trust it, nor does it mean it won't hurt you.

Don't believe me? Just look at Vioxx and the massive settlement that followed after it was determined that Merck's drug was causing people that took it to have heart attacks when they otherwise would not have been as likely to have one.

Guess what? Vioxx had the FDA's seal of approval on it.

What about Fen Phen? That had FDA approval also--for almost forty years. It was not until the 90's that the drug began to be used to weight loss. During this time hundreds of women developed heart valve problems as a result of this drug which later led to the drug being removed from the shelves and millions of dollars in lawsuits, all long after it was approved for use by the FDA.

The FDA will not save your life, only YOU can. The FDA serves as a screen to weed out potential problems. The challenge though is, what do they do when they encounter something new that there is no precedent for? More than likely they push it through and you and I end up being the true guinea pig.

This is like the police in a way, they keep us safe most of the time after the fact--that is, after the crime has been committed. It is up to you to defend your own self or home in the meantime so the police (or FDA in this case) does not come knocking on your door trying to solve the mystery of what happened.


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