My 65 year old male neighbor has a positive "cologuard"

MarinMark
MarinMark Member Posts: 148
edited March 2015 in Colorectal Cancer #1

My 65 year old neighbor said he has had colonscopy every five years since age 50.  On a website he read his insurance will pay for a cologuard test, but he doesn't know anyone who has had it done.  A cousin who is a physician ordered it for him, and he sent away for a kit with has a tub abd brush and liquid and he sent his feces to a lab.  Four weeks later he was told this cologuard test was positive.  Last colonscopy was five or six years ago.   He went to a GI doc who told him not to worry but to just get his colon examined every 5 to 10 years.  This GI doc never orders this cologuard test and doesn't know of a local doc who does.  

 

Anyone here had this cologuard test done and it was positive and the colonoscopy was normal?  Or anyone here had a positive cologuard test and a newly discovered tumor was found on colonoscopy?  If your cologuard test was normal was something significant still found?

 

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Comments

  • Lovekitties
    Lovekitties Member Posts: 3,364 Member
    From what I have read

    This test does 2 things...it tests for minute traces of blood which might indicate a problem and it also tests for genetic material which is shed from turmors.  The older and cheaper test only tests for the presence of blood in the stool.

    The article said that if a positive is found, then a colonoscopy should be done.  It is apparently more accurate than the old test for positive results, but less so for negative results.

    One of the best things about this test is that more folks may be inclinded to do it over having a colonoscopy because it does not require the prep and the procedure.  It can be done in the home.  It could also be done for those "at risk" between scheduled colonoscopies, to keep a closer watch.

    It was approved in August 2014 by the FDA and costs about $600.  That your neighbor's insurance covers it is great. 

    Regardless of the out of pocket cost, it might get more early detection for those who shy away from the colonoscopy.

    If it gets more folks to be checked, that is a good thing.

    Marie who loves kitties

     

  • BillO60
    BillO60 Member Posts: 72
    Thanks for Bringing this Up

    From the material I've read on PubMed and the National Cancer Institute site, although the test is relatively new (although research into testing fecal DNA has been going on for at least a decade) the test is not a replacement for colonoscopy but, like the fecal immunochemial test (FIT) that test for blood in the feces, it's one more screening test that might help detect colon cancer in its early stage. Where the FIT test checks for blood in feces the fecal DNA testing (in this case Cologuard) checks for blood as well as abnormal DNA that may indicate cancer.

    Research is still ongoing but Cologuard screening is covered by Medicare, Mayo Clinic began offering it to its patients in August 2014, the same month the FDA approved  Cologuard, and even the VA has been involved in some early testing.

    Something I found interesting related to what you'd asked was a note on the NCI site that indicated in one study published in 2004 by the New England Journal of Medicine, for people who were at average risk of developing colon cancer, but who had no symptoms, fecal DNA testing was better at detecting cancer than the standard FIT test that checks only for blood.

    On the flip side, the study also found that testing for abnormal DNA in the stool was more likely to have more false-positive results than the FIT. How much more likely false-positive's crop up wasn't indicated and 10 years later it would be surprising if the developers hadn't been working to fine-tune and reduce that risk. 

    Hope that helps. I'm sure your neighbor is concerned and I certainly hope it was a false-positive but he'll obviously need to see his doctor to work out further testing he'll need to find out for sure.

     

    Bill

     

  • MarinMark
    MarinMark Member Posts: 148
    BillO60 said:

    Thanks for Bringing this Up

    From the material I've read on PubMed and the National Cancer Institute site, although the test is relatively new (although research into testing fecal DNA has been going on for at least a decade) the test is not a replacement for colonoscopy but, like the fecal immunochemial test (FIT) that test for blood in the feces, it's one more screening test that might help detect colon cancer in its early stage. Where the FIT test checks for blood in feces the fecal DNA testing (in this case Cologuard) checks for blood as well as abnormal DNA that may indicate cancer.

    Research is still ongoing but Cologuard screening is covered by Medicare, Mayo Clinic began offering it to its patients in August 2014, the same month the FDA approved  Cologuard, and even the VA has been involved in some early testing.

    Something I found interesting related to what you'd asked was a note on the NCI site that indicated in one study published in 2004 by the New England Journal of Medicine, for people who were at average risk of developing colon cancer, but who had no symptoms, fecal DNA testing was better at detecting cancer than the standard FIT test that checks only for blood.

    On the flip side, the study also found that testing for abnormal DNA in the stool was more likely to have more false-positive results than the FIT. How much more likely false-positive's crop up wasn't indicated and 10 years later it would be surprising if the developers hadn't been working to fine-tune and reduce that risk. 

    Hope that helps. I'm sure your neighbor is concerned and I certainly hope it was a false-positive but he'll obviously need to see his doctor to work out further testing he'll need to find out for sure.

     

    Bill

     

    All excellent posts.  His

    All excellent posts.  His matter is more interesting since he does not have a family history of colon cancer and he had three normal colonoscopies (every 5-6 years) during the past 15 years.  This is far more than any of my friends have had!  So his last colonoscopy as just 6 years ago and was normal.

     

    None of my docs recommend the test stating that if a person is concerned, get a colonoscopy every 5-10 years instead.   Wonder if this test is predictive, that is if a person has a negative colonoscopy and a positive cologuard, will they very likely develop a colon cancer?

     

    "tests for genetic material which is shed from tumors"----  if true, what is the cause of a false positive test ?  The test seems to have too many false positives and false negatives.

     

    Anyone know the true rate of false positives with Cologuard in a 60 year old male ?

     

  • Lovekitties
    Lovekitties Member Posts: 3,364 Member
    MarinMark said:

    All excellent posts.  His

    All excellent posts.  His matter is more interesting since he does not have a family history of colon cancer and he had three normal colonoscopies (every 5-6 years) during the past 15 years.  This is far more than any of my friends have had!  So his last colonoscopy as just 6 years ago and was normal.

     

    None of my docs recommend the test stating that if a person is concerned, get a colonoscopy every 5-10 years instead.   Wonder if this test is predictive, that is if a person has a negative colonoscopy and a positive cologuard, will they very likely develop a colon cancer?

     

    "tests for genetic material which is shed from tumors"----  if true, what is the cause of a false positive test ?  The test seems to have too many false positives and false negatives.

     

    Anyone know the true rate of false positives with Cologuard in a 60 year old male ?

     

    Stats

    Statistics are not good to go by. 

    You say he hasn't had a colonoscopy in 6 years and had a positive result on this test.

    My vote would be time for another check up.

    Better to get a good result from the colonoscopy than to let something go that could be serious.

    Marie who loves kitties

  • MarinMark
    MarinMark Member Posts: 148

    Stats

    Statistics are not good to go by. 

    You say he hasn't had a colonoscopy in 6 years and had a positive result on this test.

    My vote would be time for another check up.

    Better to get a good result from the colonoscopy than to let something go that could be serious.

    Marie who loves kitties

    Neighbor had colonoscopy ZILCH NADA NOTHING ZERO

    Tonight he showed me his report with color pioctures.   Despite the POSITIVE Cologuard test, his full colonoscopy was normal.   Why was his Cologuard test positive?  What does this mean for his future?

  • Easyflip
    Easyflip Member Posts: 588
    MarinMark said:

    Neighbor had colonoscopy ZILCH NADA NOTHING ZERO

    Tonight he showed me his report with color pioctures.   Despite the POSITIVE Cologuard test, his full colonoscopy was normal.   Why was his Cologuard test positive?  What does this mean for his future?

    Ditch the

    cologuard and stick with colonoscopies. If this screening were perfected no one would go through the hassle of a colonoscopy. False positives happen all the time in medical testing. He's ruled out the big scary deadly elephant in the room so I wouldn't be ultra concerned. Ask the Doc or the company that makes it why there are false positives. I don't think it means anything for his future except to get colonoscopies at the recommended times.  Just be thankful he doesn't have cancer! Good luck!

    Easyflip/Richard

  • MarinMark
    MarinMark Member Posts: 148
    Easyflip said:

    Ditch the

    cologuard and stick with colonoscopies. If this screening were perfected no one would go through the hassle of a colonoscopy. False positives happen all the time in medical testing. He's ruled out the big scary deadly elephant in the room so I wouldn't be ultra concerned. Ask the Doc or the company that makes it why there are false positives. I don't think it means anything for his future except to get colonoscopies at the recommended times.  Just be thankful he doesn't have cancer! Good luck!

    Easyflip/Richard

    Agree with Easyflip/Richard

    http://www.bostonglobe.com/business/2014/03/24/fda-reviews-dna-based-colon-cancer-screening-kits/9ihuSUBHhQGv6dUlm93ZcO/story.html

     

    http://health.usnews.com/health-news/patient-advice/articles/2015/02/03/meet-cologuard-the-colon-cancer-test-you-can-take-at-home

     

    http://www.latimes.com/business/la-fi-lazarus-20140822-column.html

  • MarinMark
    MarinMark Member Posts: 148
    MarinMark said:
    False positives are 76% ????????

    Does this mean that 76.4% of the positive Cologuard tests are false positives ?

    "Of the positive test results, the numbers that would be viewed as false positives would be 1230 of 1611 (76.4%) with DNA testing (COLOGUARD) and 468 of 696 (67.2%) with FIT."

     

    Taken from:  http://www.nejm.org/doi/full/10.1056/NEJMoa1311194#t=articleDiscussion

  • Lovekitties
    Lovekitties Member Posts: 3,364 Member
    MarinMark said:

    False positives are 76% ????????

    Does this mean that 76.4% of the positive Cologuard tests are false positives ?

    "Of the positive test results, the numbers that would be viewed as false positives would be 1230 of 1611 (76.4%) with DNA testing (COLOGUARD) and 468 of 696 (67.2%) with FIT."

     

    Taken from:  http://www.nejm.org/doi/full/10.1056/NEJMoa1311194#t=articleDiscussion

    second article sited

    The second article you sited (nejm.org) is a year older than the one you sited  from usnew.com.

    I personally would take a false positive or a false negative any day.

    Apparently some insurance companies are convinced that is accurate enough for them to pay for.

  • MarinMark
    MarinMark Member Posts: 148

    second article sited

    The second article you sited (nejm.org) is a year older than the one you sited  from usnew.com.

    I personally would take a false positive or a false negative any day.

    Apparently some insurance companies are convinced that is accurate enough for them to pay for.

    Huh ? What in the HExx is the value of Cologuard ?

    You would like a false negative Colon test ???  Makes no sense.

    Why does Medicare and some other insurances cover this $600 test ?  What good is this Cologuard test ?   If it can miss cancers or pre-cancers, that's not good.   If it gives false positives, that's not good.

    I went for my colonoscopy yesterday.  No drugs, no meds, no pain.  Easy 10 minutes procedure and fun to watch on the screen.  Completely normal. 

    My prep was different from what others have done, and was fairly easy.  If someone said I must repeat colonoscopy in a week, no problem.  Plan on another one in four years.

     

  • Lovekitties
    Lovekitties Member Posts: 3,364 Member
    MarinMark said:

    Huh ? What in the HExx is the value of Cologuard ?

    You would like a false negative Colon test ???  Makes no sense.

    Why does Medicare and some other insurances cover this $600 test ?  What good is this Cologuard test ?   If it can miss cancers or pre-cancers, that's not good.   If it gives false positives, that's not good.

    I went for my colonoscopy yesterday.  No drugs, no meds, no pain.  Easy 10 minutes procedure and fun to watch on the screen.  Completely normal. 

    My prep was different from what others have done, and was fairly easy.  If someone said I must repeat colonoscopy in a week, no problem.  Plan on another one in four years.

     

    Sorry

    Should have read "false positive over a false negative".

    There is no test that is 100% accurate.  Even PET and CT scans and colonoscopies have been known to miss things.

    Each person has to make their own choice as to what to do.

    Glad to hear that your test was good and you had easy time with the prep.  Everyone should be so lucky.

    Marie who loves kitties

  • bruce1949
    bruce1949 Member Posts: 1
    Cologuard

    I would never recommend Cologuard to anyone.  I just used Cologuard, and got a positive result.  Based on this result, I went through 2 weeks of no aspirin or NSAIDs (I have joint pain and headaches) 24 hours of no eating (severe headache most of the day), a $100 laxative and $1,200 colonoscopy in addition to the $600 Cologuard test.  They found nothing.  I know, be happy they found nothing, not even a polyp, but what a waste of $600.  Since having the colonoscopy I have learned that in the Cologuard test, 0.6% of test subjects had cancer or precancerous polyps.  0.6%!  That means 99.4% of test subjects had no cancer!  148,000 new cases of CRC sounds like a lot of people.  That's .04% chance for all ages, and I read that 4% of people between 60 and 80 develop CRC.  If you feel the need to be tested for CRC do it, but go ahead and have the colonoscopy.  Forget Cologuard, it's a rip-off.  The CDC list CRC as the second leading cause of cancer-related deaths.  Sounds really scary, second leading cause.  They never tell you you have a .04% chance of getting it.  

  • Trubrit
    Trubrit Member Posts: 5,626 Member
    bruce1949 said:

    Cologuard

    I would never recommend Cologuard to anyone.  I just used Cologuard, and got a positive result.  Based on this result, I went through 2 weeks of no aspirin or NSAIDs (I have joint pain and headaches) 24 hours of no eating (severe headache most of the day), a $100 laxative and $1,200 colonoscopy in addition to the $600 Cologuard test.  They found nothing.  I know, be happy they found nothing, not even a polyp, but what a waste of $600.  Since having the colonoscopy I have learned that in the Cologuard test, 0.6% of test subjects had cancer or precancerous polyps.  0.6%!  That means 99.4% of test subjects had no cancer!  148,000 new cases of CRC sounds like a lot of people.  That's .04% chance for all ages, and I read that 4% of people between 60 and 80 develop CRC.  If you feel the need to be tested for CRC do it, but go ahead and have the colonoscopy.  Forget Cologuard, it's a rip-off.  The CDC list CRC as the second leading cause of cancer-related deaths.  Sounds really scary, second leading cause.  They never tell you you have a .04% chance of getting it.  

    Happy. Sorry. And welcome

    I'm glad you are free from the curse of CRC, but sorry you had to find out in such an expensive way. 

    Thank you for all of the information provided. 

    And welcome, even if we never see you post again.

    Trubrit

  • BL53931
    BL53931 Member Posts: 9
    edited November 2016 #15
    Cologuard

    I posted a new thread before seeing this one. Won't repeat what I just posted but had a Cologuard positive after years of negs using the blood test. I asked my new Doctor if she'd let me take a blood test as a back up since I cannot get in for a Colonscopy for 60 days. She argued with me and relunctantly offered that other test. If I get a neg on that one I may change doctos and see how that goes.  Any comments? 

  • DataDrivenFP
    DataDrivenFP Member Posts: 1
    BL53931 said:

    Cologuard

    I posted a new thread before seeing this one. Won't repeat what I just posted but had a Cologuard positive after years of negs using the blood test. I asked my new Doctor if she'd let me take a blood test as a back up since I cannot get in for a Colonscopy for 60 days. She argued with me and relunctantly offered that other test. If I get a neg on that one I may change doctos and see how that goes.  Any comments? 

    False positives & predictive value

    The short answer is, get the colonoscopy in two or three months (there's no rush- anytime in the next 3-6 months is ok, though sooner is better) because the screening test shows you're much more likely than the average person to have something significant.  A full answer involves a statistics lesson.

    No test is perfect.  A perfect test would always give positive results when disease is present, and negative when absent. Unfortunately, no test is perfect, so we choose them to minimize important mistakes.  Think of using a dying flashlight to look for a black cat in a dark coal cellar.  You may see the cat if it's there, and you might get an illusion as the light dies. How useful the test is depends on how likely the disease is to start with. 

    We should only screen when a disease:

    1. is fairly common
    2. is very serious
    3. has a long period when there are no symptoms, but the disease can be detected
    4. has safe and effective early treatment AND the screening test is:
    5. safe
    6. cheap and
    7. reasonably accurate

    The goal is to improve your health a little bit by getting the test.  These are hard requirements to meet-MOST disease screenings fail, or have very little value. Screening for prostate cancer makes you (just a little) MORE likely over all to die (from complications of treatment) than your risk going in from prostate cancer.

    Colon cancer screening has a small benefit, overall, one of the few that does.

    A screening test, like FIT or cologuard, should be most reliable when it's negative, so we don't miss true disease very often.  A positive screening test for a rare disease will give more false positives than true, but that's ok, since we're only testing for important diseases we'd rather not miss. A positive screening test leads to more evaluation.  Cologuard's not so good because it's so expensive, about half the cost of a much better test, colonoscopy.  

    A confirmation test, like colonoscopy, should be most reliable when it's positive, so we don't take out healthy colons, and unnecessarily expose people to the risks of surgery.  Colonoscopy has about a 5% false negative rate. Much much smaller false positive rate.

    For people 50-70 in the US,  about 1 in 300 has a cancer or a polyp, and doesn't know it.  We all have the symptoms of early colon cancer (=NO symptoms.) We want a screening strategy (not a test) to find most of them.   So using FIT every year, or colonoscopy every 10 years, is an ok screening strategy, because the chances of a false negative go down with repeat testing.

    *********************************************

    So for your situation, before the Cologuard you had a 1 in 300 chance of something you'd want to know about.  Now the odds are 1 in 3! (About 5x more likely to be a potential precancer than an early cancer; about 10x more likely to be early cancer than late.)

    You need colonoscopy, because any other negative test won't tell you reliably enough you DON'T have something you'd want to know about. If you get a positive 'blood test' (there is no good blood test for colon cancer, BTW) you still need a colonoscopy; if you get a negative 'blood test' you still need a colonoscopy!  About 60% of the time, they'll find nothing; about 35%, a polyp; about 4%, a very early cancer; about 1% a less early cancer.  Get the colonoscopy!

     

     

     

  • John23
    John23 Member Posts: 2,122
    Kudos!!

    Re:
    "You need colonoscopy, because any other negative test won't tell you reliably enough you DON'T have something you'd want to know about. If you get a positive 'blood test' (there is no good blood test for colon cancer, BTW) you still need a colonoscopy; if you get a negative 'blood test' you still need a colonoscopy! About 60% of the time, they'll find nothing; about 35%, a polyp; about 4%, a very early cancer; about 1% a less early cancer. Get the colonoscopy!"

    Well worth repeating, and as many times as we can!

    There's too, too much fear associated with a diagnosis of cancer, and it's that fear drives some individuals to do things as a "precaution", never realizing that some "preventive" measures and tests can lead into directions better off not taken. Your mention of "prostate cancer" is a perfect example!

    I'd like to thank you for one of the best informative posts I've read in quite awhile (in my not ever humble opinion)......

    Welcome!

    My best wishes,

    John

     

  • mel1950
    mel1950 Member Posts: 3
    edited December 2016 #18
    bruce1949 said:

    Cologuard

    I would never recommend Cologuard to anyone.  I just used Cologuard, and got a positive result.  Based on this result, I went through 2 weeks of no aspirin or NSAIDs (I have joint pain and headaches) 24 hours of no eating (severe headache most of the day), a $100 laxative and $1,200 colonoscopy in addition to the $600 Cologuard test.  They found nothing.  I know, be happy they found nothing, not even a polyp, but what a waste of $600.  Since having the colonoscopy I have learned that in the Cologuard test, 0.6% of test subjects had cancer or precancerous polyps.  0.6%!  That means 99.4% of test subjects had no cancer!  148,000 new cases of CRC sounds like a lot of people.  That's .04% chance for all ages, and I read that 4% of people between 60 and 80 develop CRC.  If you feel the need to be tested for CRC do it, but go ahead and have the colonoscopy.  Forget Cologuard, it's a rip-off.  The CDC list CRC as the second leading cause of cancer-related deaths.  Sounds really scary, second leading cause.  They never tell you you have a .04% chance of getting it.  

    cocoguard

    I just took a cologuard test and it came back positive.  I'm so nervous I'm going for a colonscopy on thursday.  I have a twested colon that is why I never had one.  I can't seem to think any more my nerves are shot.

  • mel1950
    mel1950 Member Posts: 3
    edited December 2016 #19
    bruce1949 said:

    Cologuard

    I would never recommend Cologuard to anyone.  I just used Cologuard, and got a positive result.  Based on this result, I went through 2 weeks of no aspirin or NSAIDs (I have joint pain and headaches) 24 hours of no eating (severe headache most of the day), a $100 laxative and $1,200 colonoscopy in addition to the $600 Cologuard test.  They found nothing.  I know, be happy they found nothing, not even a polyp, but what a waste of $600.  Since having the colonoscopy I have learned that in the Cologuard test, 0.6% of test subjects had cancer or precancerous polyps.  0.6%!  That means 99.4% of test subjects had no cancer!  148,000 new cases of CRC sounds like a lot of people.  That's .04% chance for all ages, and I read that 4% of people between 60 and 80 develop CRC.  If you feel the need to be tested for CRC do it, but go ahead and have the colonoscopy.  Forget Cologuard, it's a rip-off.  The CDC list CRC as the second leading cause of cancer-related deaths.  Sounds really scary, second leading cause.  They never tell you you have a .04% chance of getting it.  

    cologuard

    You are 100% right I had one and it also came back positive.  I thought I would die.  Had a colonscopy and thank God it was normal would never recommend it to anyone.

  • Trubrit
    Trubrit Member Posts: 5,626 Member
    mel1950 said:

    cologuard

    You are 100% right I had one and it also came back positive.  I thought I would die.  Had a colonscopy and thank God it was normal would never recommend it to anyone.

    Good news!

    So glad to hear that your test is also negative for Cancer.  May you forever have good results from your Colonoscopies.

    TRU

  • Byrdi
    Byrdi Member Posts: 1
    Cologuard

    I came up with a positive Cologuard, and after doing a colonoscopy I have a perfectly normal colon.  I just think this is a huge waste of someone's money to bother with. Have your neighbor do a regular colononoscopy. My guess is he's fine. If you read closely the rates of false positives are very high.  It's probably a way to scare people into getting the required colonoscopy tests.