Prof. Hermann Brenner, DKFZ; Dr Hongda Chen, DKFZ
Sigmoidoscopy and colonoscopy, the current gold standards for detection of CRC in the distal and total colorectum, respectively, are limited by several disadvantages, such as high costs, limited resources and poor compliance. So other cost-effective and sensitive methods for the early detection of colorectal cancer are urgently needed and very important from the health economic standpoint. Using blood samples the invention offers a protein and autoantibody set that can be used as a diagnostic tool for diagnosis and stratification and/or monitoring of a therapy of colorectal cancer.
Using biological (blood) samples from a screening colonoscopy a core panel of 4 proteins and an autoantibody (AREG, GDF-15, FasL, and Flt3L +anti-TP53) had the sensitivities for detecting early stage CRC and advance adenomas of 66.7% and 31.7% at a specificity of 80%, and the AUC of 0.82 (95% CI: 0.74-0.90) for detecting all-stage CRC. At 90% Specificity the panel had sensitivities of 56% for CRC and 22% for adenomas.
DKFZ is looking for a commercial partner for further development of the marker panel alone or in combination with other markers towards clinical application.
Based on a cohort of screening colonoscopy participants of the BliTz study between 2005-2014, including approx. 7,197 participants the biomarkers were validated.
A priority patent application “Mixed protein and autoantibody biomarker panel for diagnosing colorectal cancer” EP 17190007.9 has been filed at the Europe Patent Office September 7, 2017. A subsequent international PCT patent application has been filed as PCT/EP2018/074087. None of the patent equivalents have been published yet.
“Development and validation of a panel of five proteins as blood biomarkers for early detection of colorectal cancer” by H. Chen, J. Qian, Simone Werner, K. Cuk, P. Knebel, and H. Brenner published in Clin Epidemiol. 2017; 9: 517–526. See: PMID: 29184444 PMCID: PMC5672848 DOI: 10.2147/CLEP.S144171