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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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FDA stands for what?
By smackababy on 5/13/2010 10:07:32 AM , Rating: 3
The Food and Drug Administration. This test, according to the article, requires only a saliva sample sent back to the parent company. I don't understand how they can try and ban this? It has zero effect effect directly on the consumer's health. Is it the FDA's job to prevent me from making terrible life decisions? I don't think so!




RE: FDA stands for what?
By AntiM on 5/13/2010 10:37:42 AM , Rating: 2
I agree, it's neither a fodd or a drug. Nothing passes into the person's body. I'm glad we have the FDA looking out for us, but I don't think this falls withing their jurisdiction.


RE: FDA stands for what?
By Divide Overflow on 5/13/2010 1:35:36 PM , Rating: 1
I guess you'd want to prevent the Navy, Air Force or Marines from having anything to do with solid ground then too, huh?


RE: FDA stands for what?
By Ristogod on 5/13/2010 10:42:29 AM , Rating: 2
Agreed. What part of any of this has anything to do with Food or Drugs? It's just another example of some unrestricted government program illegally and maliciously attempting to regulate the free market to protect the interests of the government and empower them with more power and control.


RE: FDA stands for what?
By JediJeb on 5/13/2010 10:54:02 AM , Rating: 1
Considering how cheap these test are I imagine they are trying to regulate them because the medical labs would charge 5-10x more for the same test even though this company is easily making a 100% profit on the test at their prices. It now costs between $40k and $90k for the machine to do the test, and the consumables are a few dollars per test, so if you sell 9000 kits at $10 each you have paid for your equipment, a few more to pay for the consumables then the rest is pure profit. You can set up 96 tests at once on the machine so it doesn't take much time for the lab tech to process enough sample to make a nice profit either.


RE: FDA stands for what?
By clovell on 5/13/2010 5:44:32 PM , Rating: 2
They're trying to regulate them because they're unproven.


RE: FDA stands for what?
By Kurz on 5/13/2010 6:29:30 PM , Rating: 2
Are you consuming anything?
NO!

There is no need for the FDA to regulate it then.


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.

http://www.fda.gov/MedicalDevices/DeviceRegulation...

According to the source article:
quote:
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. http://www.pathway.com/more_info

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?


RE: FDA stands for what?
By FaaR on 5/13/2010 11:38:08 AM , Rating: 1
Your post read as: "How dare the government try to make sure a test does as advertised?! We DEMAND snake-oil!"

But whatever. You people should get whatever's coming to you, wether that's non-working DNA tests, or dietary supplements containing mercury or whatever.

Stupididty may not be contagious per se, but there's sure a cure for it and I'm sure some enterprising free marketeer is willing to sell it to you for a price, just as soon as the FDA steps out of the way.


RE: FDA stands for what?
By Earthmonger on 5/13/2010 1:45:51 PM , Rating: 2
Placing your trust blindly in the FDA is the scary thing. At some point in this litany of responses, I do believe it was forgotten that this is the "American Medicine" industry being discussed. The dollar goes a long way towards securing FDA approval. So, these "snakeoil peddlers" are apparently not paying their dues, and that's ruffling some feathers is it?


RE: FDA stands for what?
By Earthmonger on 5/13/2010 2:09:00 PM , Rating: 2
A couple of links for you all:
FDA's Biggest Blunders
http://health.msn.com/health-topics/articlepage.as...
Fixing A Failing FDA:
http://health.msn.com/health-topics/articlepage.as...

Hell, just Google the FDA. There are literally thousands of articles criticizing them. That the drug companies actually pay the FDA is not helping their case.


RE: FDA stands for what?
By clovell on 5/13/2010 6:07:51 PM , Rating: 2
Regulatory agencies, including the FDA have learned from a lot of these. The application fees that drug companies pay is weird, but from a financial standpoint, the agency doesn't have the resources to review the applications otherwise. It's a long way from perfect, but I wouldn't give them hell over this.


RE: FDA stands for what?
By smackababy on 5/13/2010 2:09:32 PM , Rating: 2
I don't demand snake-oil, I demand to be able to sell products not relating to foods or drugs to consumers. If the product I am selling is complete crap, it will be called as such and not sell. I don't need big brother looking in (not "out for me") on how I spend my money.


RE: FDA stands for what?
By Reclaimer77 on 5/13/2010 4:22:51 PM , Rating: 3
The FDA is just another part of government control. There is a zero, REPEAT ZERO, percent chance that a consumer can be harmed by this product.

All other arguments are moot. The FDA supposedly exists to "protect" the Consumer. Well in this case the consumer needs no protection.


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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