Our increasing knowledge of the complex nature of molecular interactions has enabled us to not only understand physiological and pathological processes better but also to identify biological markers that define a particular state or condition—so-called biomarkers.
Molecular biomarkers are now used across many disciplines and can be any molecule, part of a molecule, or even a particular configuration that is both detectable and measurable, and the level or appearance of which is indicative of a particular biological state.
Biomarkers are useful tools in the diagnosis of disease or the identification of a predisposition. However, basing a clinical decision on a single biomarker can lead to a significant number of false positives. It is therefore more reliable and robust to use a panel of biomarkers that act as a fingerprint of the disease and its status.
Oxford Gene Technology (OGT) has experience in this area, and in this article we look specifically at the development of clinically relevant autoantibody-based diagnostic biomarker panels.
It is estimated that the biomarker market will be worth over $20 billion by 2014, driven by increasing demand from both the drug discovery and the clinical service sectors. Within the clinical sector, biomarkers impact multiple application areas, including diagnostics, prognostics, and companion diagnostics/personalized medicine.
Focusing on Diagnosis
Creating practical and robust diagnostic biomarker panels requires a dependable system for detecting and measuring them. Antibodies have several properties that make them excellent indicators of disease, and their detection forms the basis of many in vitro diagnostic tests.
Interestingly, in addition to generating antibodies against foreign molecules, the immune system also produces autoantibodies in response to a large number of pathogenic processes. The appearance of autoantibodies can precede disease symptoms by many years and, due to the inherent amplification of the immune system, they are readily detectable, making them ideal for presymptomatic and early diagnosis of disease.
When evaluating clinically relevant diagnostic tests, it is preferable to use those requiring the least invasive sample collection methods such as peripheral blood collection. Autoantibodies can be readily detected in blood serum.