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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 Seemonkeyscanfly on 5/13/2010 11:28:46 AM , Rating: 2
Yea... but until then I want to invest into this company... I bet they sell a ton of these kits. Then in about a years or two time I will sell, because someone is going to come down with cancer after one of these kits indicates you will be cancer free. Even if they have a disclosure the legal action will happen and it will cost a lot of money.

I'm also interested in how a "pre-pregnancy" test works? What you pee on a stick and it say in blue writing on the stick, "yes if you have sex at a future time there is a chance you can become pregnant. Unprotected sex increase these chances."

Maybe we need more snake oil salesman to either weed out the knuckleheads or hopefully make people start thinking more and deeper about what they are hearing and seeing.


By clovell on 5/13/2010 5:19:32 PM , Rating: 2
> Maybe we need more snake oil salesman to either weed out the knuckleheads or hopefully make people start thinking more and deeper about what they are hearing and seeing.

That's a stupid idea. Read some Upton Sinclair.


By Seemonkeyscanfly on 5/13/2010 6:44:56 PM , Rating: 2
No it's not stupid, it's real life. Upton Sinclair was a Socialist. Socialist tend to wear out of focused rose colored glasses.

Using some quotes from Wikipedia:

http://en.wikipedia.org/wiki/Upton_Sinclair
Quote Wiki: "In his book The Jungle, Sinclair wrote about the inhumane conditions wage earners experience because of unregulated capitalism. Ironically, he began writing this novel on Christmas. His purpose was to expose the truth behind the unregulated industry of the day, including the poor treatment of immigrant workers, the poverty they lived in, the unsafe working conditions, and their job insecurity, besides their low wages. Sinclair wrote that, in capitalism, the wealthy are in control, and something needs to be done about it. He was the founder of the End Poverty in California (EPIC) movement.[11]"

He is wrong, in capitalism the creative and smart are in control.. (it's why a teenage single mother's child could grow up to be a billionaire... Do not believe go ask Oprah Winfrey). Yes, having money does not hurt, and it is good to have something over seeing areas like safety and give a voice to the little man. However, if he were alive today and I was able to talk to him. I would first tell him to look into a mirror and remind him that he was a poor man's son, yet he was very wealthy... If he was correct he should be poor because he was not born wealthy with his parent in control, because the "wealthy are in control in capitalism." However, his Dad was poor and his grandparent well off... So he saw the difference between the two life styles and he at one point in his life said, I'm not going to live the life of a poor man. Being he lived in a capitalistic society he could make something of himself without the aid of a rich person controlling his life and events around him.

quote Wiki:"His father was a liquor salesman whose alcoholism shadowed his son's childhood. Sinclair had wealthy grandparents with whom he often stayed. This gave him insight into how both the rich and the poor lived during the late nineteenth century."

So to that I say, maybe we need to wake some people up in this country... The government has or is giving too much protection for our own good. We need more people deciding for themselves that: "I'm not going to be poor, I'm not going to believe everything I'm told, I'm not going to be told how to live my life, I'm not going to be a servant to my government but they to me, and so on." Right now we have too many followers and no leaders. Maybe what makes for good leaders is people being burned or harmed from time to time.


By bigdawg1988 on 5/13/2010 9:47:06 PM , Rating: 2
I'm also interested in how a "pre-pregnancy" test works?

It is not a test to see if you can become pregnant, it is a test to see if you may carry any harmful genetic traits that could be passed down, like sickle-cell, hodgkins, etc.
Probably requires both partners to be accurate though.


By tmouse on 5/14/2010 8:56:44 AM , Rating: 2
Actually I think there say they are testing for potential miscarriages since they offer other specific "tests" for the diseases you mentioned.


"If a man really wants to make a million dollars, the best way would be to start his own religion." -- Scientology founder L. Ron. Hubbard














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