First blood test for concussion assessment wins FDA approval

Written by Roisin Conneely

The FDA has approved the marketing of a novel blood test to assess mild traumatic brain injury (mTBI) in adults, potentially leading to a reduction in the number of unnecessary CT scans.
A more efficient diagnostic tool?

Currently, the majority of patients with suspected mTBI are assessed using the 15-point Glasgow Coma scale, followed by CT scanning to detect intracranial brain lesions that may require treatment.

The Banyan Brain Trauma Indicator, developed by Banyan Biomarkers (CA, USA) is a blood test measuring levels of UCH-L1 and GFAP, proteins released by the brain into the bloodstream following injury. Detection of these proteins may help to decide which patients are likely to exhibit brain lesions and will need a CT scan. Results of the test can be available in as little as 3− 4 hours.

It is hoped that the biomarker will help to reduce the number of patients undergoing CT scans unnecessarily, thereby reducing hospital costs and patient radiation exposure.

The approval comes following analysis of data from a multi-center study of 1947 blood samples from adults with suspected mTBI. The indicator’s efficacy was evaluated by comparing blood test results with CT scans, demonstrating that the biomarker was able to predict the presence of lesions on a scan in 97.5% of cases and their absence from scans 99.6% of the time.

The findings indicate that the test may reliably detect the presence or absence of intracranial lesions, which may be useful for healthcare professionals when determining which patients will need to undergo a CT scan.

Still a way to go for mTBI biomarkers

Hannah Wilson, Programme Manager for The Drake Foundation (London, UK), a non-for-profit organization focussed on improving evidence-based measures for the management of concussion injuries commented; “It’s great to see approval of a blood biomarker test in this field, especially if it can reduce unnecessary CT scans in those who have experienced traumatic brain injury. However, contrary to some media reports, this is not a blood test for concussion and there is still a way to go in the development of an objective diagnostic test.”

Source: www.fda.gov/newsevents/newsroom/pressannouncements/ucm596531.htm