Clinical evidence studies overview


1. The first clinical studies were performed on 109 cases/Controls during 2010 and 2011 by CREATE Health Cancer Center in Lund, Sweden. The studies showed that IMMray™ PanCan-d biomarker signature can differentiate the pancreatic cancer patients from the healthy individuals.


2. In 2012-2013, CREATEHealth Cancer Center in Lund, Sweden, carried out one clinical evidence study with 148 serum samples from healthy controls/pancreatitis/pancreatic cancer patients. The study showed that IMMray™ PanCan-d can differentiate between the healthy donors, the pancreatitis patients and the pancreatic cancer patients.


3.  During 2013-2014, CREATE Health performed a multi center trial study in collaboration with five different hospitals in Spain. 338 case/control were tested with IMMray™ PanCan-d and the results showed that our biomarker signature for diagnosing pancreatic cancer is robust, running the test at the different sites was not a confounding factor.


4.  CREATE Health Cancer Center initiated in 2014 a long term collaboration with TMUCIH, Tianjin Medical University Cancer Institute and Hospital, one of the two national cancer centers in China. This clinical evidence study was carried out on 308 case/control Asian patients and it concluded that IMMray™ PanCan-d is suitable also for populations with different genetic make-up. Additionally, the study provides the first indication that the test detects pancreatic cancer patients in early asymptomatic stage I and II. A publication summarizing the results of this study will be submitted shortly.


5.  In 2015, CREATE Health Translational Cancer Center in collaboration with Immunovia have completed a retrospective study demonstrating that the IMMray™ PanCan-d test is able to differentiate with 96% accuracy patients with early resectable stages of pancreatic cancer, stage I and II, from the healthy controls. When analyzing all stages of pancreatic cancer, the accuracy of Immunovia´s test is reported as high as 98%. The study covered 1400 blood samples, making it the largest study for diagnosing pancreatic cancer in all stages.