Biomarkers on the Brain
The human brain is the most complex biological organ in the living world. However, as with all living things we are not invincible and we remain susceptible to a host of medical disorders, some of which are related to the malfunction of our brains. Examples of common neurological illnesses include stroke, motor neuron disease (MND), Alzheimer’s disease (AD) and other dementias, Parkinson’s disease (PD) and Huntington’s disease (HD). Ideally, each of these conditions would have to exhibit a unique pathology to allow clinicians to distinguish particular conditions and give a reliable diagnosis and treatment. In reality, however, many neurodegenerative diseases share similar symptoms and features and the task of diagnosis is often challenging.
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Biomarker features
A biomarker is a measurable attribute associated with the clinical status of a patient. The National Institutes of Health (NIH) defines a biomarker as: “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or pharmacologic responses to a therapeutic intervention”
Biomarkers for monitoring the efficacy of a medicine must capture the beneficial effect of the therapy. In clinical trials biomarkers can be used to: enable the characterization of patient populations, quantify the extent to which new drugs reach intended targets or indeed alter proposed disease mechanisms to achieve clinical outcomes. Biomarkers also have utility in preclinical drug development where they can be used to monitor efficacy or screen for adverse effects in model systems prior to testing in man. Finally, biomarker tests must be reliable, reproducible and inexpensive,as well as noninvasive and simple to perform.
The Need for Biomarkers for CNS Diseases
Some diseases have well characterized biomarkers already incorporated into diagnostic tests and therapeutic decision making. Well known biomarkers in oncology include human epidermal growth factor receptor 2 (HER2) and estrogen receptor/progesterone receptor (ER/PR) for breast cancer, and carcinoembryonic antigen (CEA) as a prognostic biomarker for colorectal cancer. Meanwhile, other research areas and diseases are lagging in biomarker discoveries. Dr. Ronald Hayes, Founder and Chief Science Officer at Banyan Biomarkers stated, “CNS biomarkers are very late to the game compared to the use of biomarkers in other areas, especially oncology and cardiology.”
Source: The Insight Partners