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FDA approves first ever blood test for traumatic brain injuries

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The new blood test was developed with funding from the U.S. Department of Defense and U.S. Army.

Israeli Laboratory Leads Western World In Blood Testing
NES TSIONA, ISRAEL - JANUARY 22: A laboratory technician checks human blood samples before placing the glass tubes on an automated testing line at the Maccabi Health Services HMO central laboratory January 22, 2006 in Nes Tsiona which is located in central Israel. The laboratory, which operates a fully automated system complete with advanced robotics, can test more than 50,000 blood samples a day. The lab is considered one of the most modern of its kind in the western world. (Photo by David Silverman/Getty Images)
Photo by David Silverman/Getty Images

According to Health.mil, the official website of the U.S. Military health system, the U.S. Food and Drug Administration (FDA) has green-lit a revolutionary new blood-test that can detect the presence of traumatic brain injuries.

Florida-based Banyan Biomarkers, with funding from the U.S. Department of Defense and U.S. Army, created the blood-test, which they have trademarked as the Brain Trauma Indicator (BTI). The test was designed to detect two specific protein markers; Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrilliary Acidic Protein (GFAP).

Research has shown that both UCH-L1 and GFAP appear in the blood at elevated levels up to twelve-hours after a head injury that is significant enough to cause bleeding in the brain.

When the brain bleeds it causes large clots (hematomas) in or around the brain. Left unattended, those clots can swell so large that they eventually cause the brain to shift position within the skull. That shifting of position can cause fatal damage to the brain. Diagnosing this kind of brain bleed is difficult because the initial bleeding is rarely noticed by the sufferer. Because of that is it very hard, if not impossible, for a physician to detect a brain bleed using traditional diagnostic methods in the immediate aftermath of the injury.

Traditional diagnostic methods for head trauma have long included visual examinations of the patient and a period of questioning designed to detect abnormal brain function. Because individuals with brain bleeds can pass these tests there are many incidents of sufferers collapsing and dying from brain bleeds minutes — or even hours — after being given the all clear.

In the past four years, combat sports athletes Tim Hague, Joao Carvalho, Scott Westgarth, and David Whittom have all died in scenarios similar to the one described above. The best way to prevent deaths from brain bleeds is to quickly get the sufferer into surgery so doctors can begin removing blood and relieving pressure on the brain.

The new blood test hopes to eliminate scenarios where a brain bleed is not diagnosed and then left to grow to a point where it will be fatal. Since UCH-L1 and GFAP are only present in elevated levels when a brain bleed is likely, and not during a mild traumatic injury (concussion), creators say the test will be able to quickly tell whether or not an individual has suffered a head injury that requires immediate medical intervention.

Another benefit of using a blood-test to check for brain bleeds is that it potentially replaces the need to perform a CT scan. CT scans subject the brain to radiation and it is best to avoid this exposure when possible; especially with pediatric patients.

The BTI was developed primarily for military use. Health.mil reported that, according to the Defense and Veterans Brain Injury Center, in past decade over 375,000 service members have been diagnosed with a traumatic brain injury. 82% of those TBI cases were classified as concussions.

News of this test comes weeks after Temple University revealed they too were working on a blood test to diagnose TBIs. The Temple test is designed to detect microscopic changes in cells inside the brains’ blood vessels. That test is geared more to diagnosing injuries to the brain which have a high probability of leading to chronic traumatic encephalaopathy (CTE).

The only diagnostic tool for TBIs in combat sports that goes beyond simple examinations and questions like “What date is it?” and “Where are you now?” is the Infrascanner by InfraScan. That handheld brain imaging device was approved by the FDA in 2013. It allows ringside physicians to do a quick scan of fighters’ brains after a bout to see if the brain is bleeding.

The infrascanner has been used at Bellator shows in the past. The device is also owned by the California State Athletic Commission and is available for ringside physicians at all boxing and MMA events in the State. The infrascanner was also purchased by the Miami Dolphins and the Pittsburgh Steelers of the NFL.