FDA Reviews Novel Blood Test for Concussion Evaluation

Understanding Concussions

The FDA has recently examined a new blood test known as the Banyan Brain Trauma Indicator, designed to aid in evaluating adults with suspected concussions. Mild traumatic brain injuries, commonly referred to as concussions, occur due to a sudden impact to the head or a penetrating injury that disrupts normal brain function. These injuries can lead to various symptoms, including impaired thinking, memory issues, movement dysfunction, sensory changes, and emotional disturbances.

Current Assessment Methods

Traditionally, concussion assessments utilize the 15-point Glasgow Coma Scale, which evaluates neurological function through eye, verbal, and motor response assessments. Additionally, computed tomography (CT) scans are used to identify brain tissue damage or intracranial lesions. However, most patients exhibiting concussion symptoms receive negative results on their CT scans, resulting in unnecessary radiation exposure and increased healthcare costs.

Need for Alternative Testing Options

Healthcare providers recognize the necessity for alternative blood-testing methods to reduce the reliance on neuroimaging tests, minimize radiation exposure, and lower healthcare expenses. In light of this need, the FDA has approved the marketing of the Banyan Brain Trauma Indicator, which is expected to be available for use within the next six months.

How the Brain Trauma Indicator Works

The Banyan Brain Trauma Indicator functions by measuring specific protein levels, including UCH-L1 and GFAP, that are released into the bloodstream following a head injury. A prospective clinical study involving 1,947 adults with suspected concussions revealed that this blood test accurately predicted the presence of intracranial lesions on CT scans with an impressive 97.5% accuracy. Furthermore, it demonstrated a 99.6% accuracy rate in predicting the absence of lesions on CT scans. These findings suggest that the Brain Trauma Indicator can be an effective tool in optimizing patient care by re-evaluating the necessity of CT scans.

Conclusion

The introduction of the Banyan Brain Trauma Indicator marks a significant advancement in concussion evaluation, providing a promising alternative to traditional imaging methods.

Written by Haisam Shah, BSc

Reference: FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults. U.S. Food and Drug Administration News Release. (2018). https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm