Retrospective study process
We have run 6 retrospective clinical studies (defined as studies looking backward in time by using already collected well defined samples of the known disease) based on 2,500 patient blood samples of pancreatic ductal adenocarcinoma (PDAC) and matched healthy controls. Our goal has been to generate a unique biomarker signature for all stages of pancreatic cancer (I-IV), with the main focus on early stages (I-II) when the cancer is still resectable by surgical procedures.
The studies have been carried out in three phases: the discovery phase, the pre-validation phase and the validation phase. Each phase consisting of two steps; first “training” the system to recognize the biomarker signature of PDAC patients to create a clear distinction between cancer and healthy individuals, and then testing the result of that training.
Each phase has been larger than the previous phase making it the largest retrospective study ever done in pancreatic cancer.
The four discovery studies that lead to the development of Immunovias first test called IMMray™ PanCan-d, are presented in four publications (see publications) covering 700 retrospective blood samples from pancreatic ductal adenocarcinoma (PDAC) patients of stages I-IV and matched controls.
1,355 patient blood samples for the pre-validation phase were obtained in collaboration with Rikshospitalet in Denmark, an important Scandinavian biobank with extremely good clinical records. The results were further validated using an American cohort of 429 blood samples of all stages and matched controls. The study was performed in collaboration with Oregon Health and Science University Hospital, Knight Cancer Institute and Brenden-Colton Center for Pancreatic cancer in Portland, Oregon, USA (see figure below).