Cancer is the second leading cause of death worldwide, accounting for 10 million deaths in 2020. Although a new class of cancer medications, Immune Checkpoint Inhibitors (ICIs), has been approved for different cancer indications and represents a true breakthrough, only 10–50% of advanced cancer patients respond to the treatment. This unpredictability of results, together with risks of adverse effects and high costs, restricts the overall impact potential of ICIs. Predicting patient responses to these treatments is therefore critical to fully realizing their potential.
PamGene’s IOpener® is a ground-breaking diagnostic test designed to predict patient response to these cancer medications (ICIs). Made possible by PamGene’s proprietary technology, which analyses kinase activity in patient immune cells, the test can predict a patient’s response to ICI therapy before treatment start, using only a simple blood draw.
As part of the ROUTINE project, PamGene has:
- Further developed the IOpener® platform into a standardized and easily implementable solution applicable to melanoma and non-small cell lung cancer, while integrating new data types (multi-omics biomarkers) to further improve test results towards an Iopener® test that can be applied to a range of cancer indications.
- Started a clinical utility interventional study of the IOpener®-melanoma test in the Netherlands and a clinical utility study observational study in Germany. Furthermore, the study design has been completed for a clinical observational study on the clinical utility of the IOpener®-NSCLC test. In addition, initial studies towards health and economic benefit of the IOpener tests have been completed which will be updated with the real-world data from the clinical utility studies. This evidence will be used to support market access and reimbursement by health insurers.
- PamGene’s has prepared its marketing & sales organization for the start of commercialization and has implemented logistical workflows for the further commercialization of the IOpener® platform.
