Epigenomics: US study suggests blood-based Septin9 CRC screening could save lives
Epigenomics AG announced findings from a health economic study by Prof. Uri Ladabaum, M.D., M.S., et al. from the Division of Gastroenterology and Hepatology, Stanford University School of Medicine, USA.
According to the study, Septin9 testing provides potential for saving lives while being health economically beneficial as an attractive screening alternative to established methods for a population that would otherwise be non-compliant to colorectal cancer screening.
The study, which was published in “Cancer Epidemiology, Biomarkers & Prevention”, concluded that Septin9 tests would decrease CRC incidence by 41% and CRC mortality by 61% assuming optimal uptake. In addition, Septin9 tests have the potential to demonstrate significant economic benefits at acceptable costs by increasing screening rates and improving adherence over time compared to other strategies. At 75% adherence with the blood-based Septin9 test, compared to under 20% with stool-based tests (FIT) per screening cycle, Septin9 based CRC screening would be cost-effective. In the comparison, current FIT tests would be more effective and less costly than all other alternatives, assuming optimal uptake, adherence and follow-up, but this has not yet been achieved in practice.
“Colorectal cancer is the third most common cancer globally and the second most common cancer in industrialized countries. As observed in other cancer indications, screening and early detection of cancers could decrease mortality significantly. Although established screening strategies are very effective and cost efficient, compliance rates are devastatingly low due to the partly invasive and/or uncomfortable nature of the established screening methods. At least one of three eligible US citizens does not undergo CRC screening, resulting in more than 60% of CRC cases being detected in late, symptomatic stages,” explained Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. “CRC screening with a convenient blood test has the potential to significantly improve screening uptake and adherence and ultimately reduce CRC incidence and mortality, as well as resulting healthcare cost.”
The basis for comparison between different screening methods in the Ladabaum study were the published results of the PRESEPT study, run with a prototype version of the Septin9 assay, and historical FIT data. There were no direct comparison data between the two methods at the time. Epigenomics recently conducted a head-to-head comparison study between its Epi proColon® test, currently under PMA review by the FDA, and FIT demonstrating non-inferiority of Epi proColon® to FIT with respect to sensitivity. The achieved sensitivity for Epi proColon was 73%, compared to 68% for FIT.
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