CIRCULAR VISION 2.0 · Circular DNA in screening and prognosis of pancreatic cancer

Despite significant advancements in cancer therapy, the inadequate diagnosis and prognosis of many common cancers continue to limit the full potential of life-saving treatments. This gap is particularly evident in the case of pancreatic ductal adenocarcinoma (PDAC), where late-stage diagnosis, coupled with limited treatment options, results in a mere 12% five-year survival rate for patients. To improve survival rates, innovative technologies that facilitate early detection are urgently needed. In response to this unmet need, our preceding research has identified a novel tumor biomarker – circular DNA from chromosomes. Under the FET project CIRCULAR VISION, we have successfully developed a technology tailored for early-stage detection and prognosis of PDAC based on circular DNA profiles from plasma and tumors. The current project seeks to advance this technology towards commercialization. Our strategic roadmap includes maturation and validation of the Circle-DNA technology to TRL5 by advancing our molecular methods for purification of circular DNA from tumor and plasma, optimizing our computational method for mapping of sequenced circular DNA, and building a machine-learning classifier for detection of cancer from maps of circular plasma DNA. We will validate the Circle-DNA technology for screening on plasma and for the prognostic solution on tumors from ~1000 individuals. To commercialize our transformative technology, we will develop a robust and comprehensive business plan for our spin-out company, CARE-DNA, initiate fund-raising activities to secure future financing, map the regulatory approval pathway under the In Vitro Diagnostic Regulation, and prepare the launch of early commercial activities targeting hospitals in Denmark. By aligning cutting-edge scientific innovation with a clear commercial trajectory, this project is poised to make a profound impact on PDAC diagnosis and prognosis, which can ultimately transform patient outcomes across an array of cancers.