Epi proColon® 2.0 CE: A Blood-Based Screening Test for Colorectal Cancer

Abstract

Epi proColon 2.0 CE is a blood-based test designed to aid in the early detection of colorectal cancer. The test comprises a qualitative assay for the polymerase chain reaction (PCR) detection of methylated Septin9 DNA, the presence of which is associated with colorectal cancer: however, positive results should be verified by colonoscopy or sigmoidoscopy. Epi proColon 2.0 CE discriminated between patients with colorectal cancer and healthy controls with high clinical sensitivity and specificity in pivotal case-control studies. The sensitivity of the test did not appear to be affected by the tumour location or by patient age or gender. In addition, limited data suggest that Epi proColon 2.0 CE discriminated between patients with colorectal cancer and healthy controls with higher sensitivity and generally similar specificity to that of the faecal immunochemical test, and with higher sensitivity and specificity to that of the guaiac-based faecal occult blood test (statistical data not available). In an observational study, most patients who refused colonoscopy for screening accepted a non-invasive test option as an alternative, and preferred Epi proColon 2.0 CE over a stool-based test. Large prospective trials of Epi proColon 2.0 CE in a screening setting will be required to further elucidate the cost-effectiveness of the test. Nevertheless, currently available data suggests that Epi proColon 2.0 CE has the potential to be a sensitive and convenient screening option for patients refusing screening by colonoscopy.

Multiplex methylated DNA testing in plasma with high sensitivity and specificity for colorectal cancer screening

“…17 Epi proColon 2.0 assay, a blood ctDNA-based SEPT9 methylation assay for CRC screening, has recently been approved by both FDA and Chinese FDA. 26 It showed a sensitivity of 68.2% and a specificity of 78.2% in a large cohort study with 1/3 algorithm. 27 Another clinical trial reported that its sensitivity for detecting stage I CRC was as low as 35.0%.…”

“…Consequently, DNA methylation testing in bodily fluids represents a powerful diagnostic tool in the clinical management of malignant diseases . Epi proColon 2.0 assay, a blood ctDNA‐based SEPT9 methylation assay for CRC screening, has recently been approved by both FDA and Chinese FDA . It showed a sensitivity of 68.2% and a specificity of 78.2% in a large cohort study with 1/3 algorithm .…”

“…Another clinical trial reported that its sensitivity for detecting stage I CRC was as low as 35.0% . And several case‐control studies reported that its sensitivity for detecting CRC ranged from 73.3% to 81.0% . Overall, although methylated SEPT9 was the only blood based biomarker approved by FDA for CRC screening, its sensitivity did not show significant advantage over FIT .…”

Screening for Colorectal Cancer Based on the Promoter Methylation Status of the Septin 9 Gene in Plasma Cell Free DNA

“…Epi proColon 2.0 CE: Technical aspects and clinical performance for version 2.0 of the test were recently summarized [31]. The optimized assay was first CE certified as Epi proColon 2.0 for the European and world market excluding the US.…”

“…Test performance (Table 1) was evaluated in a number of case control studies in Europe and China [27,[31][32][33][34]. As outlined in these studies, test sensitivity was reported to range from 73-81% and test specificity was reported to range from 96-99%.…”