Pancreatic cancer test to offer life-saving early diagnosis
An innovative Swedish SME will soon launch a life-saving test for one of the most lethal and hard-to-detect forms of cancer. Clinically validated in an EU-funded project, the test could revolutionise the diagnosis of pancreatic cancer, providing early detection with unprecedented accuracy, boosting patient survival rates and enabling widespread screening of high-risk groups.
Updated on 21 November 2019
Pancreatic cancer is the fourth leading cause of death from cancer in Europe, claiming more than 90 000 lives each year. Rarely diagnosed early due to the lack of effective screening techniques, it has the lowest survival rate of all cancers: patients chances of living for more than five years after initial diagnosis are only around 7 %.
However, that could soon change with the planned commercial launch of IMMray PanCan-d, a novel blood test developed by Swedish healthcare firm Immunovia. Using one of the worlds most advanced recombinant antibody microarray platforms, the test detects the unique signature of biomarkers that reveals the imprint of pancreatic cancer on the immune system.
Clinical trials conducted in the EU-funded IMMPACT project have shown the test is capable of detecting the most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC), with an accuracy of more than 90 %.
Our optimisation study showed for the first time that IMMray PanCan-d could differentiate PDAC patients in stages I to IV from non-PDAC patients with non-specific but concerning symptoms with accuracies ranging from 90 % to 98 %, says Laura Chirica, Immunovias chief commercial officer.
Significant boost in survival rates
Early diagnosis is crucial to saving patients lives. Studies suggest that reliable detection during stage I or II while PDAC tumours are still confined to the pancreas and are removable by surgery could boost five-year survival rates to as high as 50 %.
Today, pancreatic cancer is usually diagnosed far too late when it is no longer resectable [able to be removed] by surgical procedures, Chirica says.
She points to data from Swedens cancer registry showing that for diseases like breast cancer or colorectal cancer, for which screening is common, the number of diagnosed patients is much higher than the number of deceased patients. For pancreatic cancer, the number of deceased surpasses the number of diagnosed because patients pass away before the cancer is even detected.
Despite the expected roll-out of faster and more efficient testing using the IMMray PanCan-d, widespread screening of the entire population for pancreatic cancer would not be socio-economically justifiable. Thus, Immunovias ongoing prospective studies are designed to validate the technology among three high-risk groups who have a greater need for routine screening. These groups will be among the first to benefit from the commercial launch of the test: people with a family history of pancreatic cancer; new-onset diabetics over 50 years of age; and patients with symptoms indicative of the disease.
Studies involving more than 10 000 individuals are currently running at 27 hospitals in the USA, Sweden, Canada, the UK and Spain. These studies are designed to provide data and results that will drive adoption by healthcare providers and encourage widespread availability of the test for all high-risk groups of patients, Chirica explains. Each step in the validation process is a major milestone bringing us closer to gaining regulatory approval for IMMray PanCan-d and offering the test commercially.
Immunovia plans to begin commercial sales of one type of the test in the USA in the third quarter of 2020 at its own laboratory in Marlborough, Massachusetts. It is also seeking European regulatory approval to make IMMray PanCan-d available via Immunovias Laboratory Services in Lund, Sweden, focusing commercialisation initially on the countries involved in the prospective studies.
In parallel, Immunovia is exploring using the technology for diagnosing lung cancer, the leading cause of death from cancer in Europe. Preliminary studies show a similar blood test, based on the IMMray platform, could differentiate lung-cancer samples from healthy control samples with an accuracy of 95 %.