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Thread: Cologuard for colon cancer screening

  1. #1

    Cologuard for colon cancer screening

    http://www.exactsciences.com/solution/screeningtest

    Good news - no bowel prep
    Not so good news - 13% false positive rate ( 13% of people without colon cancer or pre-cancer tested positive )

    Medicare approved coverage earlier this month.

    Hopefully private insurance will fall in line by early 2015.

    Out of pocket costs $600


    (I probably should have posted this in Science, Medicine and Technology - please move, if appropriate.)
    Last edited by 2drwhofans; 10-29-2014 at 10:55 PM.

  2. #2
    What I wonder is how good this would be for spinal cord injured people who do dig stim as we are more likely to have blood in our stool and hemoroids and that sort of thing. My understanding is this test is mainly screening for the presence of blood in the stool even though they try to say it is more sophisticated.
    "Life is about how you
    respond to not only the
    challenges you're dealt but
    the challenges you seek...If
    you have no goals, no
    mountains to climb, your
    soul dies".~Liz Fordred

  3. #3
    Good point. Any blood in the stool would result in a positive Cologuard test and you'd be advised to have the colonoscopy as a follow up.

  4. #4
    Quote Originally Posted by 2drwhofans View Post
    Good point. Any blood in the stool would result in a positive Cologuard test and you'd be advised to have the colonoscopy as a follow up.
    I found this on their site: "...Patients should not provide a sample if they have diarrhea or blood in their urine or stool (for example, bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding, or menstruation)...."

    I tried to find out what the test kit consists of, but they avoid answering that question online. It sounds more like a dixie cup sample size. I don't know, we have had the option of mailing in a smear of it on a wooden stick for years. I'm high risk, so I get the full treatment instead. What they are saying sounds familiar though.
    I have had periodic paralysis all my life. I lost my ability to walk in 2011 beginning with a spinal block, which was used for a hip fracture caused by periodic paralysis.

  5. #5
    Sigh, I saw this on the news two days after I had a colonoscopy. But hey 50 years old, dad and grandfather died of colon cancer and not a polyp to be found, so could have been worse.

  6. #6
    This is a good site with multi media presentations that shows the test kit and interviews with patients and doctors: http://www.multivu.com/players/Engli...rectal-cancer/

    Cologuard tests for 11 distinct molecular biomarkers to identify cancer and precancer. The biomarkers include 7 DNA mutation biomarkers, 2 DNA methylation biomarkers, 1 Hemoglobin biomarker, and 1 Beta actin.

    The test is delivered to your home in a box that looks to be about a 8 inch cube. The box has a zipper lock plastic liner. See below for contents. Once the test is completed, you package the test container in the same box, seal it up and UPS picks it up from your home.

    All the best,
    GJ

    Name:  Cologuard.jpg
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  7. #7
    I had my annual physical today and talked to my doctor about Cologuard. He's intrigued and ordered the test for me. I should receive it in about a week. I'll report back on my experience and results.

    We talked about the Hemoglobin component of the test. He did a occult blood smear test today, and if the Hemoglobin component of the test comes back positive, he will order an InSure FIT test, an immunochemical based test. Then he will weigh what he knows about my potential for bleeding during a bowel program to these other tests.

    All the best,
    GJ

  8. #8
    I'd inquired last week and my doctor sent in the orders. The Customer Service department from Exact Sciences called today regarding payment. For non-Medicare clients, they ask for $50 to send out the kit and, once the test is complete, they'll bill insurance for the balance. Our PPO insurance hasn't yet approved Cologuard so we'd be responsible for the balance once all appeals had been exhausted. They seemed confident that our insurance would be covering Cologuard by early 2015.
    We'll have to get a new order from the doctor once our coverage starts. Customer service said they only hold the prescription for 30 days.

    This direct to consumer marketing for medical diagnostic tests is interesting. It seems that both gjnl and I asked our doctors before they knew.

    There's no other way to put it gjnl except: "hope everything comes out well".

  9. #9
    Quote Originally Posted by 2drwhofans View Post
    I'd inquired last week and my doctor sent in the orders. The Customer Service department from Exact Sciences called today regarding payment. For non-Medicare clients, they ask for $50 to send out the kit and, once the test is complete, they'll bill insurance for the balance. Our PPO insurance hasn't yet approved Cologuard so we'd be responsible for the balance once all appeals had been exhausted. They seemed confident that our insurance would be covering Cologuard by early 2015.
    We'll have to get a new order from the doctor once our coverage starts. Customer service said they only hold the prescription for 30 days.

    This direct to consumer marketing for medical diagnostic tests is interesting. It seems that both gjnl and I asked our doctors before they knew.

    There's no other way to put it gjnl except: "hope everything comes out well".
    I don't consider this test as direct to consumer, your doc has be order this test just like any other test, whether UA/C&S, blood occult, CBC, etc., etc. The difference is that FDA and Medicare have approved the test for in home administration instead of an in clinic colonoscopy or lab delivered test.

    As you say...to be seen.

    All the best,
    GJ

  10. #10
    I don't want to detract from my original intention which was to let members of this forum know about Medicare coverage for Cologuard.

    That said, I think that this product's marketing is actually a classic example of DTCPA or, Direct To Consumer Pharmaceutical Advertising. The USA and New Zealand are the only two countries that allow DTPCA to include product claims.

    I first learned about Cologuard this summer from reading their full-page NY Times advertisement. Cologuard had just gotten FDA approval but still had no Medicare coverage and no CPT billing code. In addition to attracting investors, the whole idea behind this ad (as well as every Viagra, Lyrica, Pradaxa and Abilify commercial that run on TV) is to encourage consumers to begin a dialogue with their doctors. The company's desired end result is for the doctor to place an order. They do this without the expense of employing Pharmaceutical Sales Representatives to go from office to office.

    The CBC, UA and Chemistry panel have been routine annual doctors office tests for decades. Have a look at Theranos for the next potential wave of DTCPA.
    http://www.theranos.com
    They say they can to do multiple lab tests, with a single drop of blood and with a doctors order but not necessarily a doctors office visit. No tourniquets ,no slapping up veins and no 20g needles.

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