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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 Connoisseur on 5/13/2010 12:14:54 PM , Rating: 3
That's assuming the consumer is aware that a product is killing or damaging them. If it weren't for a regulating agency, what incentive would a company have to perform long term testing? What incentive would they have to list potential side effects?

It's easy to say that lawsuits and consumer sentiment would make the companies self-regulate but this isn't always the case. Oftentimes, there are many casualties over a long period of time before someone starts taking notice. Just look at phen-phen. I understand the irony that this drug was approved by the FDA as were many other harmful foods/drugs. I'm not saying the FDA is perfect (far from it) but at least there's ONE regulating body which demands a MINIMUM level of testing and quality.

As for those Chinese products you mentioned. They have to go through regulatory approval by the FDA as well. If they didn't, what motivation would they have to ensure that they meet minimum safety requirements?


By AEvangel on 5/13/2010 1:11:17 PM , Rating: 1
quote:
That's assuming the consumer is aware that a product is killing or damaging them. If it weren't for a regulating agency, what incentive would a company have to perform long term testing? What incentive would they have to list potential side effects?


What incentive do they have now...Like I said their are tons of drugs out their right now that have side effects and that are killing the people taking them. That is why all day long I see commercials on TV for some ambulance chasing attorney wanting to get your case for a drug you took that was FDA approved that has somehow hurt you.

The real problem with the FDA like most Federal agency is the curroption. Almost every single one of these Big Pharma companies has former employees on the FDA testing boards that help smooth the way for their drugs through the process.

I would rather see independent testing agencies rather then ones controlled and mandated by the government, because what happens when the FDA screws up, which they do quite often. NOTHING, no one gets fired no one gets in trouble. The congress has meetings and talks a good game, but no real reform or changes are made. Also the courts wont let you sue or or hold anyone their criminally responsible where you would through independent agencies.

The more people realize that Big Govt is not the answer for all are woes the better and safer this country will become.


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