On April 24, 2020 Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the "Company") reported that Epi proColon, the first and only FDA-approved blood-test for colorectal cancer (CRC) screening, has been included in the 2020 National Comprehensive Cancer Network (NCCN) CRC Guidelines (Press release, Epigenomics, APR 24, 2020, View Source [SID1234556585]).
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NCCN updated their 2020 CRC guidelines in a manner consistent with Epi proColon’s (Septin9) FDA-approved indications. The new NCCN guidelines state that although the mSEPT9 blood test is "not recommended for routine screening", it however "can be considered for patients who refuse other screening modalities". Epi proColon’s FDA approved indications for use are the following:
The Epi proColon test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon test. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results should be used in combination with physician’s assessment and individual risk factors in guiding patient management.
"We are pleased with the inclusion of Epi proColon in the 2020 NCCN guidelines in close alignment with the blood test’s FDA-approved intended use," stated Epigenomics CEO Greg Hamilton. "NCCN’s latest guideline update further highlights the significant opportunity to address the over 30 million Americans who currently do not participate in CRC screening. We believe Epi proColon has the potential to significantly increase the screening rates and most importantly save lives."
Epigenomics AG looks forward to future NCCN guidelines to include key data such as an annual recommendation for the test interval, which could be based on outcomes from the recently published microsimulation paper (D’Andrea et.al. epub – Nov. 2019 – Cancer Medicine. 2020; 9:824.), which was not referenced by the 2020 NCCN guidelines. These data demonstrate that annual Septin9 screening results in comparable long-term benefits and less harms as compared to the "gold standard" colonoscopy every ten years. The Cancer Medicine publication was not included as part of this latest 2020 NCCN guideline as it was published shortly after their literature review cut-off date and subsequent panel review meeting.