Published: Fri, February 16, 2018
Medical | By Jackie Banks

FDA Permits First Blood Test Detecting Concussion

FDA Permits First Blood Test Detecting Concussion

The Brain Trauma Indicator works by measuring Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrilliary Acidic Protein (GFA) within 12 hours of head injury; these two brain-specific protein biomarkers rapidly appear in the blood after a brain injury. It's created to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.

In announcing the approval FDA commissioner Scott Gottlieb said the blood test fitted with his organisation's plan to reduce unnecessary radiation exposure as much as possible.

The FDA's decision was based on data from a clinical study of 1,947 blood samples from patients with suspected concussion that compared the blood test results with results of CT scans.

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A study of almost 2,000 individual blood samples saw the Brain Trauma Indicator accurately predict the presence of intracranial lesions on CT scan 97.5 percent of the time, while correctly predicting the absence of said lesions 99.6 percent of the time. The company developed the test with partial support from a contract with the U.S. Army. The FDA inspected and approved for showcasing the Banyan Brain Trauma Indicator in less than a half year as a component of its Breakthrough Devices Program. When the test results come out in four hours, they can then help doctors decide if a CT scan is needed. CT scans are special X-ray tests that cost money and expose patients to radiation. "The FDA's audit group worked intimately with the test engineer and the U.S. Branch of Defense to assist a blood test for the assessment of mTBI that can be utilized both in the mainland U.S. and also outside U.S. research centers that administration the American military". But the remainder may have bruising, bleeding or swelling in the brain, and need a CT scan to locate, monitor and possibly treat the injury.

According to the U.S. Centers for Disease Control and Prevention, there were approximately 2.8 million incidents involving traumatic brain injury emergency department visits, hospitalizations and deaths in 2013.

Levels of the blood proteins after mTBI can help predict patients that could have intracranial lesions visible by CT scan and those that won't. Banyan Biomarkers picked up the approval after showing the test reliably rules out intracranial lesions. "A blood test to aid in concussion evaluation is an important tool for the American public and for our service members overseas, who need access to quick and accurate tests", said Jeffrey Shuren, director of FDA's medical device division.

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