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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 10:17:45 AM , Rating: 2
I don't quite see the harm in allowing Walmart to sell these kits. As long as the tests are legitimate and provide accurate results, or, at least a disclaimer on the efficacy of them, why not let them sell the kits?

If anything, making genomic tests more readily available to the public can be a very good thing when people are assessing their lifestyle and future prospects, or, even more importantly, trying to make an informed decision as to whether they should consider breeding or not.

Sure, there could be imposter tests out there that are snake-oil, but, when was the last time you went to a store and _did not_ see something that was snake oil? I see it all the time, and the government does nothing to prevent it.

In this case here, people could consult a physician for further advice after they receive their test results. It might not be a perfect or flawless model, but at least this is a step towards making it easier for all of us to know more about ourselves.

By ussfletcher on 5/13/2010 10:35:35 AM , Rating: 3
It is Walgreen's Pharmacy selling the tests, not Walmart. The writer is clearly baffled by the similar names.

By perspicacity on 5/13/2010 11:03:05 AM , Rating: 2
How do you think that happens where you can trust what you read on labels when you go into the drug store?

It's because the FDA reviewed it first.

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.

By tmouse on 5/14/2010 9:09:41 AM , Rating: 2
The problem I have is the FDA requires test manufactures to show they adhere to standards. We are talking about VERY limited tests, most for small fractions of the disease so passing the test certainly does not mean you will not get the disease nor does failing the test mean you will get it (I consider having an disease associated mutation a bad thing so passing in this case means you do not have the mutation). Without someone explaining this what will someone do if test indicates Hunting's disease, a disease with currently no cure. Some will commit suicide or get themselves sterilized ect. At least with a doctor or genetic consoler you will be better informed. I'm going to assume most of these tests will be PCR based, although they could be high throughput sequence based, but in either case sample handling is crucial. There are a lot of laboratory standards that should be proven to be in place before a company should be allowed to sell a product, else the results are worth nothing. I'm all for less expensive tests, but in these cases given the sheer magnitude of impact on the lives of the individuals a trained person should be available to explain what the results really mean.

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