Monday, 18 June, 2018

Concussion Blood Test Wins FDA Approval

U.S. health regulators have approved the first blood test to help diagnose traumatic brain injuries U.S. health regulators have approved the first blood test to help diagnose traumatic brain injuries
Judith Alexander | 16 February, 2018, 07:00

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 Food and Drug Administration on Wednesday approved a first-ever blood test to detect the telltale signs of serious brain injury, bringing to fruition a long quest to make the diagnosis of concussions simpler and more precise.

The Banyan Brain Trauma Indicator-a test that works by measuring levels of the proteins UCH-L1 and GFAP in a patient's blood-was reviewed and authorized for marketing within six months of submission, according to the statement.

Levels of these blood proteins can help predict if a patient has probability of having intracranial lesions, which can help health care professionals determine how to manage their patients' conditions.

Test results now can be available within three to four hours.

Kounang also cited Hank Nordhoff, chairman and CEO of Banyan Biomarkers, who noted that the new test would be significantly less expensive than the CT Scans.

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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.

FDA approved the test following a clinical study of 1,900 blood samples from people with concussion or mild traumatic brain injury.

The device was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time, and those without lesions on a CT scan 99.6% of the time.

The test, created by US biotech company Banyan Biomarkers, detects two proteins in brain cells that can leak into the bloodstream following a brain injury. Many in the medical community believe that concussions and CTE - chronic traumatic encephalopathy, which many National Football League players have been shown to suffer from - are separate concerns. The approval was granted to Banyan Biomarkers, Inc. As the proteins arise from different pathways, researchers speculated analyzing both would yield tests with superior sensitivity and specificity than diagnostics that look at the biomarkers in isolation.

According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of almost 50,000 people.

With Department of Defense funding, Banyan's research shows its Brain Trauma Indicator can accurately pick up brain trauma later found on CT scans.

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