Glib
The problem with EpiPro Colon is pairing an annual testing regimen with a 20% false positive rate; that's 4x FIT's 5% false positive rate, a difference which is not "slight". This combination of poor specificity and frequent (once/yr) testing produces more than twice as many unnecessary colonoscopies as any other testing method, and more than three times as many as Cologuard.
These unnecessary colonoscopies end up making the test more expensive (and more dangerous in regard to colonoscopy complications) than Cologuard or FIT.
Salerno
Yes, but people doing blood test are unwilling to make a colonscopy, so they will make only one every 10 years as advised by USPTSF, Colonscopy every 10 years is approved. They will not make more like those positive for Cologuard, they will make only one, no more if not absolutely necessary for the presence of symptoms, but that is another question.
Glib
What a typical Epi Pro Colon patient (who's already averse to testing for colon cancer) will do in response to a false positive from this test will vary greatly. Some will simply go home avoid the colonoscopy and worry about it unnecessarily for several years. Some will get a colonoscopy and never trust any testing again. Some will be sent to the emergency room for one of the complications from colonoscopy (for a disease they didn't have).
If they never get colon cancer (and the vast majority won't as it is a low incidence disease) and continue testing with Epi Pro annually after this, it's highly likely they will get another false positive within the next few tests.
PSalerno
In any case they should not do more colonscopies than 1 every 10 years, this is the recommendation and the risk is outmatched by the benefit. The responsibility is upon the doctors.
HAL @ Glib
I think your view is a little bit too narrow.
1.) FIT specificity is better that Cologuard's (95 vs 87%), with Cologuard still 1 out of 10 has a false positive test and hence needs to perform a colonoscopy
2.)Cologuard has a better sensitivity of 92% vs. 68% for FIT
3.)Cologuard is 18 times more expensive than FIT,
> does this justify the 24% advantage in a world where you say CRC has a low incidence?
> Insurance companies will not in any case reimburse the test if certain conditions are not fulfilled (i.e. if FIT is done within 3 years the test will not be covered)
4.) adverse effects from colonoscopy are fairly rare. Please read studies: only 2.8 out 1.000 procedures produce complications
www.asge.org/assets/0/71542/71544/...742-8158-55b6bef2a568.pdf
5.) why should another stool test, that Cologuard indeed is, improve compliance rate if handling with stool is the main issue why 23 mln. screening eligible US Americans that don't opt for this kind of method?
6.) the 20% false positives found after screening with the blood test ProColon have in 56% of the cases polyps that will be resected while performing colonoscopy
>Colonoscopy in those cases was not for nothing, since also polyps can turn into CRC cancer
7.)you don't talk about the additional CRC cases found by EpiProColon
> if the application of Epi ProColon would not have proven medical and cost benefit FDA would have hardly approved the test!
Example: in a one million population with 50% colonoscopy, 15% FIT and another 15% Epi ProColon you would find additional 179 CRC cases. Those are the unwilling who refuse stool based test and colonoscopies. If those 15% would have been untreated they would most likely align stage III and IV (CRC comes with less symptoms). If it comes to cost those cases would produce between 150 and 300k $ treatment cost per patient.
On the other hand: 20% produced false positives have to undergo colonoscopy with the outcome described above and would produce between 1000 and 2000 $ cost. However, we live in an healthcare system in which the colonoscopy should be performed every 10 years for everybody!
The math is easy: Of 1 mln app. 166.000 people are screening eligible (50-75 years old).
Of those 15%, 24.900 patients, decide for Epi Procolon.
Of those 179 people where found with CRC. 4.980 would have a false positive result (20% of 166.000). Those have to undergo colonoscopy. Cost 5-10 mln. $
The 179 found CRC cases would avoid 27-54 mln, $ treatment cost. Even if you have additional cost of rare adverse events while colonoscopy this number won't be topped.
Look at page 19: www.epigenomics.com/fileadmin/site_files/...ion_August2016.pdf
Still your argument that someone refusing either stool test or colonoscopy after a positive ProColon test the patient will not go home and do nothing - that is utter nonsense. A good doctor will advice him to do the colonoscopy to double check. And in 72% of the cases the patient has CRC - in 18% not. 20% have false positive result.
So everything can be condensed to one thing: Comfortability. With a big blood count the patient can do CRC test, if she belongs to the unwilling. If her test is false positive she has the uncomfortability to do colonoscopy. If she does not like it anymore she might opt for any other screening method. However, one target is also in those cases aligned: bring more people into CRC screening.