In a previous article on our website, we explained what biomarkers are and why they are useful in the fight against pancreatic cancer. In this article, we explain how biomarkers are developed.
Pancreatic cancer still has a very low survival rate compared with other types of cancer, despite advances in treatment. One factor greatly contributing to this is that the patient often has no symptoms. Only at an advanced stage of symptoms are observed.
Therefore, current biomarker research for pancreatic cancer focuses primarily on early detection and diagnosis.
Currently a standard biomarker for pancreatic cancer is not available, and this contributes to the late detection of the disease. However, potential markers have been discovered in recent years, and recent developments in the detection of micro-RNA or circulating tumour cells are promising for earlier detection of pancreatic cancer.
Carbohydrate antigen 19-9 (CA19-9) is currently the best biomarker for the diagnosis of pancreatic cancer. Unfortunately, most scientific studies using this marker as a complementary diagnostic test show that CA19-9 is often not specific or sensitive enough to be used to screen patients.
Therefore, CA19-9 is often combined with other biomarkers to increase its diagnostic value.
The first stage in the development of a biomarker is called the discovery stage: a single molecule or a panel of molecules is investigated in a patient population. When a suitable candidate emerges, an analytical study follows. This step performed to measure whether the biomarker is accurate and reliable, is called analytical validation.
The analytical validation is followed by clinical validation. It must then be proven that the marker is useful in making the right decisions in predicting, diagnosing or treating the disease.
Before the biomarker can be used in clinical practice, regulatory approval must be received.
ElmediX is currently developing a biomarker that could predict whether our hyperthermia treatment is effective in a specific patient. By developing a predictive biomarker for hyperthermia, we can screen patients and treat those patients who will benefit the most.