Pancreatic cancer is the fourth leading cause of death by cancer in Europe, with the lowest survival rate of all the cancers. The EU-funded IMMPACT project set out to clinically validate the early diagnosis of pancreatic cancer using a serum biomarker signature. This signature works by tapping in to the body’s own cancer detection abilities using one of the world’s most advanced recombinant antibody microarray platforms. The project conducted the world’s largest retrospective studies of early stage I and II detection of pancreatic ductal adenocarcinoma (PDAC), with 96 percent accuracy.
IMMPACT also successfully started the pre-commercialization of the key element of the underlying technology–the antibody array platform IMMrayTM. The platform, which was demonstrated to be very robust with low technical variations, now has a state of the art facility ready for clinical use.
The IMMrayTM blood based test aims to detect the pancreatic cancer in the early stages when the cancer is still resectable. This could lead to a major increase in the five-year survival rates which are currently as low as 5-8 percent.
Utilizing affinity proteomics technology
IMMPACT came about because as project coordinator and Immunovia Vice President R&D Dr Linda Mellby, explains, “There was an unmet clinical need for pancreatologists to have a reliable biomarker signature which primarily indicates whether the patient has cancer, not if the patient has a high risk of getting cancer.”
The project took thousands of blood samples from patients with PDAC and compared those against controls consisting of healthy individuals. Key to the process was the IMMray array technology (owned by Immunovia AB), and its advanced bioinformatics algorithms which measures the immune system’s response to disease.
When a disease develops there is a change in the pattern (relative concentration) of proteins in blood and IMMray can detect these patterns. By deciphering, in parallel, differences in the pattern of proteins between hundreds of the blood samples, the bioinformatic tools were able to determine which of all these biomarkers, in combination, hold the most information. As Dr Mellby elaborates, “Each of the markers selected contains unique information which adds to the total. Markers that contain the same information as others selected are not included. This enables high specificity and sensitivity at the same time.”
Clinically available, and for additional diseases
IMMPACT has established prospective studies and testing of the IMMray technology in the three high risk groups for pancreatic cancer. Firstly, they are looking at those at risk for familiar/hereditary reasons in more than 20 clinics across Spain, United Kingdom, Scandinavia and the United States (US). Secondly, people in Sweden over 50 with a first diagnosis of diabetes (with Denmark and the US to follow).
The project will introduce the test commercially in 2019 in their Immunovia laboratory in Boston, US. It will also be made available in the EU through the clinical laboratory in Lund, Sweden. To assure quality accuracy and consistency, the test will be accredited in the US by the College of American Pathologists (CAP) and have a Clinical Laboratory Improvement Amendments (CLIA) certification and will have a CE mark in Europe.
Reflecting on the project’s achievements, Dr Mellby says, “We’re proud to be establishing a technology that can solve a major health problem and save lives. Today five-year survival is between 5 and 8 percent but if detected early it could be as high as 50 percent. Also this technology is applicable to other complex diseases such as lung cancer or rheumatoid arthritis.”