22.07.2013 | 130722_Press_release_Epigenomics_AG_Ladabaum_study
- CRC screening with blood-based Septin9 tests has potential to improve screening uptake and adherence rates
- Septin9 testing could decrease colorectal cancer (CRC) incidence by 41% and CRC mortality by 61% at optimal screening uptake rates
- Septin9 based screening shown to be cost-effective over no screening
Berlin, Germany, and U.S.A., July 22, 2013 – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today 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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Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.
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