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Cologuard false positive, anyone else???

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Cologuard false positive, anyone else???

Old 12-08-18, 12:59 PM
  #1  
rayman54
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Cologuard false positive, anyone else???

This was also posted to Slowtwitch as well:

Hello,

I'm a male endurance athlete, 64 YO. At my most recent annual physical my Dr. mentioned that it was "that" time again, referring to a colonoscopy. However he mentioned that he was now suggesting to his patients a "new" procedure that did not require the usual and somewhat unpleasant preparation. I was not convinced, but was persuaded by him and agreed to go that route. The route in question was the Cologuard test.

Basically, you poop in a container and send it to a lab for evaluation. My test came back as positive. This positive result then necessitated a traditional colonoscopy in order to more definitively determine if there was an issue. When I met with the Dr. who would be doing the colonoscopy he told me that I would be responsible for the entire expense of the procedure due to the positive Cologuard test. He related that health insurances pay for diagnostic procedures of this type whether it be the Cologuard of the tradiotional colonoscopy (which by the way is considered to be the gold standard). But since I'd gotten the positive Cologuard, insurance no longer would cover the additional work!!!

Long story short, the colonoscopy came back normal with no issues. Thankfully! However I was now out about a total of $1,300....

I asked the Dr. if the fact that I was near the end of a marathon training cycle had any impact on the positive result. He wasn't sure until I mentioned that it is not unusual for distance athletes to have trace amounts of stool blood as a result of the training. Immediately he said yes, that that was the likely cause of the positive as the Cologuard test checks for abnormal DNA AND the presence of blood.

My family Dr. knows of my marathon training and I feel he should not have recommended the Cologuard in my case.

So, I'm posting this to: see if others have had the Cologuard, see if others had false positives, and to warn others in this situation to seriously reconsider using the Cologuard vs. colonoscopy. In hindsight I should have checked things out before agreeing to the test. But being told by your Dr. that this is "now the way" carries a lot of weight, but will NOT happen again!

Thanks
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Old 12-08-18, 02:29 PM
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Thanks for posting. I just sent in my Cologuard sample last week. My doctor said we could do it either way, and chose Cologuard, which I later came to regret after learning about its low accuracy for detecting adenomas. Unfortunately I didn't find this out until I had the test kit in hand with the documentation in front of me. If I had it to do over, I'd just take the colonoscopy.

Seems crazy that insurance wouldn't pay (I know, they're in the business of not paying) when a follow-up is medically indicated, as in the case of a positive result, false or not. Are they saying the right thing to do is ignore the test result? Crazy.

Cologuard says their false negative rate is 8% for colorectal cancer and 58% (!!!) for advanced adenomas. Why did I choose this?

Last edited by rseeker; 12-08-18 at 03:23 PM.
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Old 12-08-18, 02:55 PM
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It sounds like an issue with deductibles.

Insurance pays for diagnostic tests... but everything else gets hit by the deductible. I'd call the insurance company, and argue that the colonoscopy was also a diagnostic test as it wasn't being used for curative purposes (although they frequently snag small polyps with a colonoscopy).

Do Hemorrhoids impact that test?

$1300 isn't bad. That is less than I'm not paying for insurance.
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Old 12-08-18, 02:58 PM
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CologuardŽ is a screening test, not a diagnostic test, and thus can be expected to give a significant number of false positive results; I suspect that's why insurance companies might not want to cover it. Colonoscopy and biopsy of suspicious findings is really the only definitive way to diagnose colon cancer, and if they're going to end up paying for a colonoscopy anyway, why not skip the screening test?

I wasn't aware that CologuardŽ was that expensive; good to know. Pro-tip: check with your insurance policy to see if it is covered before going ahead with it.
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Old 12-08-18, 03:21 PM
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Originally Posted by JohnDThompson

I wasn't aware that CologuardŽ was that expensive; good to know. Pro-tip: check with your insurance policy to see if it is covered before going ahead with it.
The $1300 was the cost of the colonoscopy, not paid by insurance, presumably due to deductibles

However, I'm seeing the Cologuard for $650

There used to be a smear rapid screening test for occult blood.
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Old 12-08-18, 03:30 PM
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OP here,

Yes the colonoscopy was $1300 out of pocket. And yes it was due to not having met the deductible limit prior. I would guess that hemorrhoids, if bleeding, would indeed cause a false positive. After reading further I discovered that this test is advised for those who refuse to go the colonoscopy route. At that point any info is better than nothing.....
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Old 12-08-18, 03:30 PM
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Originally Posted by CliffordK
There used to be a smear rapid screening test for occult blood.
There still is: the "hemoccult" occult blood test. Very quick, very cheap, but only detects the presence of blood in the stool, which could be due to a number of things including cancer, hemorrhoids, upper GI bleeding (e.g. ulcers, leaking varicosities), etc.
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Old 12-08-18, 03:53 PM
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Originally Posted by JohnDThompson
There still is: the "hemoccult" occult blood test. Very quick, very cheap, but only detects the presence of blood in the stool, which could be due to a number of things including cancer, hemorrhoids, upper GI bleeding (e.g. ulcers, leaking varicosities), etc.
I wonder if the OP could have been given the hemoccult test as pre-screening. Perhaps take a couple of cards home with himself.

Then if the hemoccult comes up positive, then do directly to the colonsocopy, and skip the Cologuard test.

If the hemoccult comes up negative, then decide what is next.

Would his hemoccult test have been positive or negative?
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Old 12-08-18, 04:34 PM
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OP -- sorry for the hassles you went through. Would have been nice for doc to have warned you, if he knew.

68yo also endurance, 105 miles Thursday, 105 miles today, marathon at Disney World in 5 weeks, Sebring 12/24 Hour RAAM Qualifier in February, still contemplating Ironman FL for 70th in 2020 -----

I've had numerous colonoscopies with no issues and frankly don't mind the prep or procedure. LOVE the Propofol. Currently Prostate Cancer Surviving, just had a recurrence earlier this year, so proper testing is a prerequisite as far as I am concerned. No easy-peasy mail in testing for me. Do it the right way the first time --- period.
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Old 12-08-18, 05:31 PM
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Since colorectal cancer screening is so important and colonoscopies are invasive and expensive, I would have expected insurance companies to prefer that patients have the Cologard test first. I guess not. That's ridiculous.

What your story means to me: I'm sticking with colonoscopies. The only tough thing for me is the fasting.
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Old 12-08-18, 07:06 PM
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Originally Posted by CliffordK
I wonder if the OP could have been given the hemoccult test as pre-screening. Perhaps take a couple of cards home with himself.

Then if the hemoccult comes up positive, then do directly to the colonsocopy, and skip the Cologuard test.

If the hemoccult comes up negative, then decide what is next.

Would his hemoccult test have been positive or negative?
The hemoccult test is non-specific; just as positive hemoccult showing the presence of blood in the stool can be an indication of cancer (among many other things), a negative hemoccult doesn't mean there's no cancer. In many ways, a false negative can be worse than a false positive, so the recommendation is still a colonoscopy.

The CologuardŽ test is more specific than the hemoccult test because it checks for both blood and specific cancer-related DNA markers, so there are fewer false negatives. But a false positive can be expensive. My feeling is that CologuardŽ might best be indicated for people for whom colonoscopy might be too risky, for one reason or another.
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Old 12-08-18, 07:21 PM
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Originally Posted by Biker395

What your story means to me: I'm sticking with colonoscopies. The only tough thing for me is the fasting.
/\ This. The only time I get to pig out on Jello.
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Old 12-09-18, 05:58 AM
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Medicare covers Cologuard. My primary care doc, who’s about my age told me it was time for a colonoscopy. When I went in for the pre-procedure appointment, the (younger) doc “talked me into” using the Cologuard test, since I’m not considered a high risk for colon cancer. He said the test is more than 90% accurate in detecting problems (and said not even colonoscopies are foolproof). He did explain that any blood (like from hemmorroids) would result in a positive test.
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Old 12-09-18, 08:19 AM
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Cologuard is a good screening tool. It's not as good as colonoscopy but does have obvious advantages, not the least of which is that many people who refuse colonoscopy screening for colon cancer will pay the $600 for Cologuard and get screened that way. As a result...many more people are getting screened, which is a good thing. It's also a good thing for doctors who do colonoscopy, since the more people screened, the more people get colonoscopy. This is because there are more people, and because of the false positive rate. The result is a substantial net gain in the number of colonoscopies being done. Add in the fact that colorectal cancer screening is now moving to begin at age 45 instead of 50...well, we're getting to the point where there just aren't enough colonoscopes or doctors qualified to use them. The colonoscopy business is booming.

When doctors do any kind of screening test, two concepts of primary concern are the false negative rate and the false positive rate. Obviously, it's better to have a false positive than a false negative. Fortunately for patients, Cologuard's false negative rate for colon cancer is low. Fortunately for colonoscopists, the false positive rate is high.

Regarding the false negative rate...it's low, about 0.1%, for cancer. But about a third (33%) of the patients with a "negative" Cologuard will have one or more pre-cancerous polyps many of which, if left in place will advance to a colon cancer, and might do so within the recommended three-year screening interval. IOW, only about 2/3 of people (66%) with a negative Cologuard have a truly negative Cologuard. The concern that this high number of missed colon polyps raises is the result of the long-awaited long-term studies on the rates of colonoscopy screening programs, with polyp removal, on the incidence of colon cancer. Those studies showed a clear reduction in the number of colon cancers found due to the fact that those screening colonoscopies found and removed colon polyps before they could become cancerous. One has to therefore wonder about the long-term results of the fact that a negative Cologuard may well mean that now a substantial number of patients will have pre-cancerous colon polyps left in place, at least until they get big enough (or cancerous enough) to shed more detectable DNA.

The overall false-positive rate for Cologuard is about 10%. It's worth noting that that rate rises noticeably in the older population (>age 60) due to changes in the stability of the shed DNA in older people.

Overall, Cologuard is a good screening tool for colon cancer and a fairly good test for pre-cancerous polyps in the colon. We'll have to wait for long-term tests (20 years or so) to find out how well it affects both colon cancer rates, and colon cancer survival.


ETA:
Couple of other thoughts...Cologuard shouldn't be used in people who might have occult bleeding into the colon but that's a tough call. It might include endurance athletes, but 68 year-old endurance athletes are a pretty small patient population, especially compared to the number of patients with hemorrhoids. Throw in the number of people who are taking vitamins with iron or who ate a hamburger or steak dinner within the previous 3-4 days. The downside, as noted, is that insurance will generally pay for screening colonoscopy, but if you've had a positive Cologuard, you will have to have a colonoscopy and now that is no longer a screening colonoscopy, so deductibles and co-pays apply. Surprise!

...

Last edited by Cuyuna; 12-09-18 at 08:59 AM.
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Old 12-09-18, 09:16 AM
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Originally Posted by Cuyuna
Cologuard is a good screening tool. It's not as good as colonoscopy but does have obvious advantages, not the least of which is that many people who refuse colonoscopy screening for colon cancer will pay the $600 for Cologuard and get screened that way. As a result...many more people are getting screened, which is a good thing. It's also a good thing for doctors who do colonoscopy, since the more people screened, the more people get colonoscopy. This is because there are more people, and because of the false positive rate. The result is a substantial net gain in the number of colonoscopies being done. Add in the fact that colorectal cancer screening is now moving to begin at age 45 instead of 50...well, we're getting to the point where there just aren't enough colonoscopes or doctors qualified to use them. The colonoscopy business is booming.

When doctors do any kind of screening test, two concepts of primary concern are the false negative rate and the false positive rate. Obviously, it's better to have a false positive than a false negative. Fortunately for patients, Cologuard's false negative rate for colon cancer is low. Fortunately for colonoscopists, the false positive rate is high.

Regarding the false negative rate...it's low, about 0.1%, for cancer. But about a third (33%) of the patients with a "negative" Cologuard will have one or more pre-cancerous polyps many of which, if left in place will advance to a colon cancer, and might do so within the recommended three-year screening interval. IOW, only about 2/3 of people (66%) with a negative Cologuard have a truly negative Cologuard. The concern that this high number of missed colon polyps raises is the result of the long-awaited long-term studies on the rates of colonoscopy screening programs, with polyp removal, on the incidence of colon cancer. Those studies showed a clear reduction in the number of colon cancers found due to the fact that those screening colonoscopies found and removed colon polyps before they could become cancerous. One has to therefore wonder about the long-term results of the fact that a negative Cologuard may well mean that now a substantial number of patients will have pre-cancerous colon polyps left in place, at least until they get big enough (or cancerous enough) to shed more detectable DNA.

The overall false-positive rate for Cologuard is about 10%. It's worth noting that that rate rises noticeably in the older population (>age 60) due to changes in the stability of the shed DNA in older people.

Overall, Cologuard is a good screening tool for colon cancer and a fairly good test for pre-cancerous polyps in the colon. We'll have to wait for long-term tests (20 years or so) to find out how well it affects both colon cancer rates, and colon cancer survival.
Thanks. I'd get a colonoscopy every week if I thought it would prevent what my Grandaddy went through for years. Whatever drug they use makes it like you were never there. The first time, I watched the nurse inject just a small portion of the syringe into my IV and I quipped "Is that all I get?" She smiled and said "We'll start small and see what happen........." That's all I remember of that one.

The next time went well with a good result and a couple days later, I see a photgraph of what looks like someones lower GI on the desk and I ask the wife "where did this come from?" She said "Don't you remember? The Doc brought that to the recovery room and you had a lucid conversation about it"

TLDNR: Guy's, get your colonoscopies early and often.
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Old 12-09-18, 09:55 AM
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Originally Posted by FBOATSB
Thanks. I'd get a colonoscopy every week if I thought it would prevent what my Grandaddy went through for years. Whatever drug they use makes it like you were never there. The first time, I watched the nurse inject just a small portion of the syringe into my IV and I quipped "Is that all I get?" She smiled and said "We'll start small and see what happen........." That's all I remember of that one.

The next time went well with a good result and a couple days later, I see a photgraph of what looks like someones lower GI on the desk and I ask the wife "where did this come from?" She said "Don't you remember? The Doc brought that to the recovery room and you had a lucid conversation about it"

TLDNR: Guy's, get your colonoscopies early and often.
The two main choices of anesthesia for colonoscopy are deep sedation with Propofol or conscious sedation with Fentanyl and Versed. Propofol is administered by an anesthesiologist or anesthetist, and the Fentanyl/Versed administered by the doctor doing the scope. Propofol duration of action is a matter of minutes. Many people feel the lingering effects of Fentanyl (opiate/narcotic) for 24 hours or more, and Versed can also have memory effects for that period of time....post-Versed amnesia is common. There is a third option and that is no sedation at all. That's a significant minority, but some patients do choose that route.

Patient comfort and satisfaction is an important component of a colonoscopy procedure. The two components of colonoscopy that have contributed most significantly to patient comfort and satisfaction have been use of Propofol anesthesia and the use of carbon dioxide as an insufflation gas (instead of air). CO2 is absorbed about 150 times faster than nitrogen, so the uncomfortable bloating after most colonoscopies doesn't happen. The majority of endoscopy centers don't use either Propofol anesthesia or CO2 insufflation because the increased costs aren't usually reimbursed or because they don't have the resources (not enough anesthesiologists /anesthetists).
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Old 12-09-18, 10:09 AM
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Originally Posted by OldTryGuy
OP -- I've had numerous colonoscopies with no issues and frankly don't mind the prep or procedure. LOVE the Propofol. Currently Prostate Cancer Surviving, just had a recurrence earlier this year, so proper testing is a prerequisite as far as I am concerned. No easy-peasy mail in testing for me. Do it the right way the first time --- period.

+1
(except for cancer recurrence - so far, so good)
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Old 12-09-18, 10:25 AM
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Originally Posted by Cuyuna
Cologuard is a good screening tool. It's not as good as colonoscopy but does have obvious advantages, not the least of which is that many people who refuse colonoscopy screening for colon cancer will pay the $600 for Cologuard and get screened that way. As a result...many more people are getting screened, which is a good thing. It's also a good thing for doctors who do colonoscopy, since the more people screened, the more people get colonoscopy. This is because there are more people, and because of the false positive rate. The result is a substantial net gain in the number of colonoscopies being done. Add in the fact that colorectal cancer screening is now moving to begin at age 45 instead of 50...well, we're getting to the point where there just aren't enough colonoscopes or doctors qualified to use them. The colonoscopy business is booming.

When doctors do any kind of screening test, two concepts of primary concern are the false negative rate and the false rate. Obviously, it's better to have a false positive than a false negative. Fortunately for patients, Cologuard's false negative rate for colon cancer is low. Fortunately for colonoscopists, the false positive rate is high.

...
Thanks for the informative post. Better than anything I read when I was researching Cologuard.
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Old 12-09-18, 11:15 AM
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Originally Posted by Cuyuna
The two main choices of anesthesia for colonoscopy are deep sedation with Propofol or conscious sedation with Fentanyl and Versed. Propofol is administered by an anesthesiologist or anesthetist, and the Fentanyl/Versed administered by the doctor doing the scope.
I'm not sure exactly what was used in my last colonoscopy, but when I nurse came by to ask how I was feeling after the procedure, I realized "I haven't felt this good in months." She laughed and said "that's the morphine."
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Old 12-09-18, 11:39 AM
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Originally Posted by jon c.
I'm not sure exactly what was used in my last colonoscopy, but when I nurse came by to ask how I was feeling after the procedure, I realized "I haven't felt this good in months." She laughed and said "that's the morphine."
Morphine would be a very unusual choice these days. Most likely she didn't know what you actually got.
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Old 12-09-18, 06:26 PM
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Originally Posted by cuyuna
morphine would be a very unusual choice these days. Most likely she didn't know what you actually got.
+1
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