The Epigenomics Epi proColon test was the first liquid biopsy test to receive FDA approval, in April 2016 (here). The test detects epigenomic DNA changes in the blood that are indicative of the patient having colon cancer, without the need for a fecal matter test or colonoscopy. (Multiple companies such as Guardant, Exact, and others are now hoping for new tests with similar colon screening indications).
Meanwhile, this year, AHRQ is doing a broad evidence survey of liquid biopsy, presumably at the request of CMS (here).
Today, October 16, CMS released a response to Epigenomic's letter, a dramatic decision which will provide open ended coverage of FDA approved liquid biopsy colon cancer tests (or any blood-based biomarker) on a rolling basis, if they meet the criteria of 74% sensitivity and 90% specificity. This proposed decision is big news, because it would mean rapid coverage for companies like Guardant and Exact and others with large FDA trials for liquid biopsy CRC screening tests underway. However, the stated criteria (as a draft decision) leave the Epigenomics test non-covered.
On October 17, I posted a 15 minute deck and YouTube video about the NCD - here.
See Genomeweb coverage here.
On Monday, October 19, Exact Sciences was up +4%, Guardant Health up +2%, but both within their 5-day trading range.
The back story and links
On October 16, 2020, CMS released a proposed non-coverage decision on the Epi proColon test.
Tracking sheet here:
Request letter from company, April 2019:
(Note it was almost a year from the request to the opening).
The proposed position, with comment to November 15, is here:
It's an Interesting Decision
The decision is important for several reasons:
- The decision sets out that in the future, similar LBx tests WILL be covered, if they have an FDA marketing authorization for CRC screening, AND
- The test has sensitivity of 74% or better and specificity of 90% or better, against a colonoscopy gold standard, AND
- The test is recommended by USPSTF or one major professional society guideline.
CMS doesn't appear to provide any guidance on exactly how it would define "professional guideline or consensus statement" beyond stating the terms without further definition.
The entry point was the Epigenomics SEPT9 branded and FDA-approved test. One source of SEPT9 testing is Hariharan & Jenkins, 2020, a meta-analysis finding average sensitivity of 69% and specificity of 91% with an AUC of .89 and diagnostic odds ratio of 27. Open access here. Data was considered only up to May 2018 for this 2020 publication. One issue with this type of meta-analysis is it may confound different methods of varying sensitivity or accuracy.