Below are two additional excerpts from the CMS Medicare report...

Below are two additional excerpts from the CMS Medicare report for Epi ProColon that I mentioned into the origional post in this thread
Herre is the link again - https://www.cms.gov/MEDICARE-COVERAGE-DATABASE/view/ncacal-decision-memo.aspx?proposed=N&NCAId=299&type=Open&bc=AAgAAAAACAAA&

"The evaluation of screening tests has been largely standardized in the medical and scientific communities, and the value of a screening test may be assessed according to the following criteria:

Simplicity. In many screening programmes more than one test is used to detect one disease, and in a multiphasic programme the individual will be subjected to a number of tests within a short space of time. It is therefore essential that the tests used should be easy to administer and should be capable of use by para-medical and other personnel.
Acceptability. As screening is in most instances voluntary and a high rate of co-operation is necessary in an efficient screening programme, it is important that tests should be acceptable to the subjects.
Accuracy. The test should give a true measurement of the attribute under investigation.
Cost. The expense of screening should be considered in relation to the benefits resulting from the early detection of disease, i.e., the severity of the disease, the advantages of treatment at an early stage and the probability of cure.
Precision (sometimes called repeatability). The test should give consistent results in repeated trials.
Sensitivity. This may be defined as the ability of the test to give a positive finding when the individual screened has the disease or abnormality under investigation.
Specificity. This may be defined as the ability of the test to give a negative finding when the individual screened does not have the disease or abnormality under investigation.”(Cochrane A and Holland W. Validation of screening procedures. British Medical Bulletin 1971;27(1):3-8. PMID: 5100948).

There are a number of structured methods for evaluating screening tests. In past diagnostic imaging NCDs, we considered the evidence in the hierarchical framework of Fryback and Thornbury (1991) which has six levels of assessment.

Level 1 concerns technical quality of the images;
Level 2 addresses diagnostic accuracy, sensitivity, and specificity of the test;
Level 3 focuses on whether the information produces change in the physician's diagnostic thinking;
Level 4 concerns the effect on the patient management plan;
Level 5 measures the effect of the diagnostic information on patient outcomes;
andLevel 6 examines societal costs and benefits of the diagnostic imaging technology."



Reading through the above criteria, with Colostat in mind, it does seem to meet them all, perhaps with the exception of accuracy, which according to study 7 (800 or so patients) may require greater testing in the real world...which is where the CLIA lab pathway will be useful.

The report concludes with a summary of their criteria -



"The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:

The patient is:
age 50-85 years, and,asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and,at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

The blood-based biomarker screening test must have all of the following:
FDA market authorization with an indication for colorectal cancer screening; and proven test performance characteristics for a blood-based screening test with both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), based on the pivotal studies included in the FDA labeling."



This all seems fairly straightforward. FDA is required prior to any CMS reimbursement application being made by the company.

Note, Epi ProColon was rejected in the report for US Medicare reimbursement because it is too expensive and does not have any advantages in terms of sensitivity/specificity in comparison to the current FIT test. It does appear that Colostat has both these bases covered...