Development of a Blood biomarker for Early Detection of Pancreatic Cancer Using the Aberrant Processing of Circulating Apolipoprotein A2 Homodimers and Establishment of ‘The Platform of Evaluation for Biomarker of Cancer Early Detection (P-EBED)’ to Support Social Implementation of Early Cancer Diagnosis

<p>Pancreatic cancer is a refractory cancer. The development of a blood biomarker that can detect operable pancreatic cancer and its risk population will lead to the development of an efficient pancreatic cancer screening method, which may reduce mortality. We comprehensively screened circulating peptides in the blood of pancreatic cancer patients and their risk populations, those with benign related diseases, and healthy subjects, and found that the C-terminal amino acids of apolipoprotein-A2 dimers are specifically truncated in pancreatic cancer and in risk populations (apolipoprotein-A2 isoforms, apoA2-i). To apply this finding to clinical practice, we have constructed an enzyme-linked immuno-sorbent assay (ELISA) test system for quantitative analysis of the cleavage state of apoA2-i, and it is now under clinical development.</p><p>Clinical performance studies are required to obtain approval for in vitro diagnostics (IVD), and clinical performance studies will be conducted after protocol consultation with the Pharmaceuticals and Medical Devices Agency (PMDA). We established the “Platform for Evaluation of Biomarkers for Cancer Early Detection (P-EBED)” for social implementation of biomarkers that contribute to the early detection of cancer, and initiated verification of the clinical performance of biomarker seeds and support for IVD applications. P-EBED has begun supporting validation of the clinical performance of biomarker seeds and IVD applications.</p>