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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 frozentundra123456 on 5/13/2010 5:51:58 PM , Rating: 2
I work in medical research, and we use extensive measures to ensure data privacy. In fact, we have a whole department dedicated to human studies and how to correctly collect, secure, de-identify and process clinical data. Now you can go down to a local store and find your genotype???

I have several problems with this.

The first is that it must be proven to work accurately to tell what genotype you have. Someone has to oversee this, whether it is the FDA or some other agency. Do you want someone to tell you that you have a genetic weakness to alzheimer's disease and not be sure the typing is correct??

The second thing is that the effect of ones genetic makeup is only one part of getting a disease. Genetic testing should be done with the consultation of a physician who can tell you what the test really means and to help you deal with the results if there is a problem.

Finally, I could see legal ramifications for this in regards to employment and obtaining health and life insurance. Can an employer or insurance company force you to disclose if you have taken any of these tests, and if you have a genetic suceptibility to some disease can they deny employment or insurance coverage or increase your rates? There is a confidentiality for medical data between a doctor and a patient, but if someone tests himself, can he be forced to disclose the information?? Also, what safegards are in place to ensure that the company or a disgruntled employee does not give out the data, is it coded somehow?(de-identified).




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