CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test.


CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test.

Epigenomics is a liquid biopsy company listed on the Frankfurt Stock Exchange. Epi proColon detects colon cancer through a specific DNA called Septin9 (altered in colorectal cancer tumor cells). The company expects CMS approval anytime now and is due to launch nationwide in US this year.
These takeaways are based on their Q2 2020 Earnings Call. Frederic Hilke, the Investor Relations Manager for Epigenomics, and Greg Hamilton, the CEO of Epigenomics AG made these remarks.
1. The operational highlights for Epigenomics include:
◘ CMS’ initiation of the National Coverage Determination (NDC) process for Epi proColon in late February.
◘ Inclusion of Epi proColon in the 2020 NCCN guidelines.
◘ Publication in the Journal of the National Cancer Institute (JNCI) which concludes that Epi proColon is the test of choice for patients who are not willing to participate in FIT or colonoscopy screening.
2. Epigenomics believe that the test is necessary as there are an estimated 9 million Medicare beneficiaries who are not willing to participate in FIT or colonoscopy screening.
3. They believe that as the only FDA-approved blood-based test available, Epi proColon has the opportunity to save over 225,000 Medicare lives.
4. Epigenomics also reckoned that the annual Epi proColon testing was found to be clinically more effective than Cologuard (every 3 years) and (annual) FIT testing.
5. The company indicated that it is interesting to note the clinical benefits of Septin9 (Epi proColon) testing vs. an annual stool DNA test.
◘ Despite 92% sensitivity versus 68% sensitivity, the incidence of Colorectal Cancer is nearly identical, and the mortality is equivalent between the two tests.
◘ The implication of this is that even if future blood tests have increased sensitivity, their impact to clinical outcomes will be negligible.
6. The company feels that nearly all future blood-based test and development are going to be next-generation sequencing-based.
7. The company reckoned that annual stool DNA testing is extremely cost-ineffective. Which is why Epigenomics believes that Epi proColon is well-positioned to be the test of choice for an extended period of time.
8. The revenue for Epigenomics in the first half of 2020 was EUR 322,000. According to the company, the decrease between the first half of 2019 and 2020 was due to the effects of COVID-19 during Q2.
9. They feel that there is significant growth potential in 2021. Gregory Hamilton, Epigenomics AG – CEO & Member of the Executive Board commented, “I mean if you just think of the unscreened market alone, there’s 35 million patients who haven’t been screened.”
10. Post reimbursement, one of the key projects that the company is set to work on is expanding the label of Epi proColon from 50 to 75.
Note: The company feels that CMS will issue a positive coverage determination. As Epi proColon has met the required standards and now with the publication in JNCI, there is a published peer-reviewed evidence that Epi proColon is cost-effective and the test of choice for patients unwilling to participate in FIT or colonoscopy screening.
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References:
Edited Transcript of ECXn.DE earnings conference call or presentation
Epigenomics Annual Report 2019
Epigenomics AG: CMS Still Actively Working On Proposed Decision Memo with Goal to Publish As Soon As Possible
Related Links:
1) What has colon cancer screening got to do with self-driving cars?
2) Exact Sciences: COVID-19 will accelerate the adoption of Cologuard by one to two years toward ‘40% market share’ goal
3) 20 Takeaways from Exact Sciences call: “Cologuard fits seamlessly into a permanently changed healthcare environment”
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