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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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RE: FDA stands for what?
By amanojaku on 5/13/2010 10:50:55 AM , Rating: 3
The FDA has the right to oversee this product because it's considered a medical device, and part of a larger overall medical practice. The Center for Devices and Radiological Health is an FDA branch that is responsible for premarket approval of medical devices, from the simple class 1 toothbrush to the complex class 3 pacemaker.

According to the source article:
The FDA has never exercised its authority to approve genetic test kits because the kits have historically been used by doctors and other health-care professionals, and such tests conducted solely within labs are certified by the Centers for Medicare and Medicaid Services.

Riley said Pathway Genomics overstepped its bounds when it announced its plans to market the tests directly to the consumer at 6,000 of Walgreen’s 7,500 stores, and allow consumers to take their own saliva samples to return to the lab. Pathway also is promoting the tests’ role in helping people decide drug dosing and other treatments, Riley said.

The FDA wants Pathway Genomics to submit data showing that its tests give accurate results, Riley said.

“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,” Riley said.
This product is clearly intended to be used for medical purposes, as stated by the manufacturer. It's up to you to trust the results, but if you do, and they're incorrect, you could be in serious medical trouble. Which means you'll sue Walgreens for selling it, Pathway for making it, and the government for not regulating it. The FDA is just trying to cover its ass, and yours.

RE: FDA stands for what?
By porkpie on 5/13/10, Rating: -1
RE: FDA stands for what?
By DanNeely on 5/13/2010 11:52:28 AM , Rating: 3
The test *claims* it will tell you if you have gene X. What the FDA is asking for is proof that its results are accurate.

RE: FDA stands for what?
By clovell on 5/13/2010 5:37:48 PM , Rating: 2
If you're of the mindset that we don't need independent experts to oversee the specificity, accuracy, false-neg/pos rates, manufacture, and recommended clinical use of diagnostic devices, I don't think you're going to see reason here, either.

So, to try a different tact - You realize your toothbrush was made in China, right? Do you really want the FDA to stop checking up the toothbrushes they're selling you?

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