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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 clovell on 5/13/2010 5:41:32 PM , Rating: 1
Right, and maybe I should be allowed to tell people their LDL levels by tasting a couple drops of their blood.

The product has not undergone the necessary testing to ensure it's effective and now all of a sudden the FDA is the bad guy?

RE: FDA stands for what?
By Kurz on 5/13/2010 6:36:55 PM , Rating: 2
The product itself doesn't do the testing...
The person who purchases the Kit sends it off to a lab.

Just like a engine Oil Test... Oil test isn't the end all be all of Engine Health. It just shows the potential of problems.

The FDA's been the bad guy for YEARS!
They hold off Life saving drugs for a decade people die in the mean time. Then they boldly state we now saving X amount a year. When that X amount times 10 already died from them staling the process.

RE: FDA stands for what?
By JediJeb on 5/13/2010 7:01:49 PM , Rating: 2
If I wanted and accurate measurement of my LDL I would go to a doctor and have him check it. If I just wanted something to run at home to screen it for the heck of it then I wouldn't care if it was 100% accurate.

Yes the FDA regulates medical devices even down to home use thermometers. I haven't seen exactly what the procedure is, but it sounds like a regular PCR screen looking for markers for certain genes. Instruments to run these can be purchased by anyone if they want to invest the money. They are used in food labs now to test for bacterial contamination by DNA identification. For the food tests the process is already approved by the FDA and if I wish to start a lab and run that test I have to get FDA approval of my quality control but not reapproval of that testing method because it has already been approved by the FDA. If I want to run that test for Waste Water to look for bacterial contamination I need no approval in most states since the test is approved and I just have to list the test method I am using. If I am running the test for a non-compliance sample I need no approval of any kind because that number isn't reported to anyone in any authority.

The problem becomes if the use of this test will be used for anything more than curiosity. If it has the same disclaimer as nutraceuticals and suppliments "this product is not for the diagnosis, treatment, or prevention of any medical condition" then really the FDA can't regulate it. But as a client of our has found out, if you make any medical claim at all, you must get FDA approval. If you sell ground up carrots and claim they improve your vision you fall under FDA regulation, if you sell ground up carrots and call them Orange Stuff and make no claim, but list all ingredients as carrots, that falls under a natural product and is not regulated(though the laws are changing soon to make them regulated). I think this is what this company is shooting for, just disclaimer it with something about "this is only for informative purposes, you must discuss any results with your physician before making determinations about your health" they will be covered.

As for the FDA wanting to approve the kits, the kits are only a mouth swab, which is probably already approved. If the process is already something that has been approved and they are just calling it by another name same thing applies. Depending on what this actually is, it would be a waste of efforts to have the FDA reapprove something already proven to work, on the other hand if it is something totally new, it would be good to have the FDA look into it. It's bad to argue strongly for either side until all is known about the products.

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