The blood test can accurately and quickly identify patients with brain tissue damage, or intracranial lesions, following a head injury without the need for an expensive and time-consuming CT scan.
14, 2018 The first blood test to help diagnose a concussion has been approved by the U.S. Food and Drug Administration. The company's test returns results within four hours. "So this blood test precedes a CT scan unless you're showing signs of extreme trauma".
Because Banyan BTI is the first blood test for brain injury that the FDA has approved for sale, its approval creates a new classification for these types of diagnostics. Being able to predict whether patients have a low probability of intracranial lesions can help healthcare professionals manage patients and decide whether or not to perform a CT scan.
The new test measures levels of certain proteins that are released from the brain into the blood within 12 hours of a head injury.
"Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority", Scott Gottlieb, MD, FDA Commissioner, said in a statement.
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Traumatic brain injuries affect an estimated 10 million people globally each year; at least 2 million of them are treated in USA emergency rooms. As traumatic brain injuries mounted during the USA conflicts in Iraq and Afghanistan, the armed forces have urgently sought a blood test capable of predicting quickly whether a blow to the head has likely caused bleeding or bruising in the brain.
The decision was based on data from a prospective clinical study of 1947 individual blood samples from adults with suspected mTBI and reviewed the product's performance by comparing mTBI blood test results with CT scan results.
The move means Banyan Biomarkers can commercialize its test, giving the company an early lead in the biotech industry's race to find a way to diagnose concussions. Most people who present with concussion symptoms, like impaired memory, problems with movements or sensations, or compromised emotional function, turn out to have negative CT scans, the FDA said.
The test doesn't detect concussions and the approval won't immediately change how patients with suspected concussions or other brain trauma are treated.
Because of the USA military's role in the new test's development, Nordhoff noted that clinical trials have enrolled adults only.