Biomarkers for the Brain
A biomarker, or biological marker, is a term used to describe any measurable biological indicator or characteristic that can reflect a physiological state, such as a protein, cell, gene, hormone, or other type of molecule. The study and use of biomarkers in medicine is nothing new. Some biomarkers are straightforward and can give a definitive yes or no answer in a wide time range. Other biomarkers are difficult to detect given the minute amount of the markers present, their fleeting presence, or their occurrence in a location that is challenging to access. This means that even when a clinically relevant biomarker has been discovered, it does not necessarily translate to a viable diagnostic test or therapy.
When thinking about biomarkers, most would associate them with diagnostic tests to predict, diagnose, or provide a prognosis for a particular disease. However, biomarkers are now being utilized in drug development and regulatory decision making as they have the potential to improve the efficiency of the drug discovery and development process.
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In particular, if specific biomarkers that monitor or reflect the status of a disease can be identified, then researchers can use the expressed changes in these biomarkers to better understand how effective a new therapy is against a particular disease. Known as surrogate markers, they are tested to measure the effects of a specific treatment on disease status or progression. Including that data in a clinical trial would allow researchers to focus their efforts and resources on therapies that prove to be the most effective. In addition, pharmaceutical companies are using biomarkers to stratify patients, allowing them to move forward with the patients most likely to benefit from the drug being tested. These methods provide a greater chance of clinical trial success and regulatory approval.
Challenges in Biomarker Research for CNS Diseases
CNS diseases and disorders have several inherent challenges that have delayed multiple breakthrough biomarker discoveries in the field compared to other disease areas. Perhaps the most glaring challenge is the location of these diseases or injuries in the brain. The majority of efforts have focused on imaging techniques, such as MRI or PET, which involve expensive scans only available at hospitals or specific medical labs. In contrast, biomarkers for other disease types can be measured by simple blood or urine tests at point-of-care.
Another challenge in biomarker research discussed by the experts is the fact that labs analyze biomarkers with different commercial assay platforms with various limits of detection (LoD) and limits of quantitation (LoQ) (i.e., the smallest concentration of an analyte that can be measured by the assay). These variables can make reproducibility and comparability of data across studies and different assay platforms very difficult. Once a diagnostic test moves into the FDA approval process, the assay is highly validated and standardized.
Despite these challenges, ongoing efforts to find clinical biomarkers for CNS diseases are buoyed by the few success stories in the field. One such breakthrough came from Banyan Biomarkers in February 2018, when the company received FDA marketing authorization for the first TBI diagnostic test that measures two biomarkers that rapidly appear in the blood after a brain injury. Hayes explained that the diagnosis of TBI has been rather poor and mostly based on computerized tomography (CT) scans that show bleeding in the brain, which is not always present with mild TBIs.
Followings are the companies operating in this research are dvanced Brain Monitoring, Electrical Geodesics, Johnson & Johnson, F. Hoffmann-La Roche Ltd., Seimens Healthnineers, GE Healthcare, NeuroVista, Nexus-DX, Qiagen N.V., and Lifesign LLC., Natus Medical and BrainScope.