US FDA approves first blood test for detecting concussion

The US Food and Drug Administration has for the first time approved a blood test to help detect concussion in adults

The test works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Researchers compared mTBI blood results to results generated by a CT scan and quickly noted the Brain Trauma Indicator's efficacy-it was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and the absence of intracranial lesions 99.6 percent of the time. Elevated levels of the proteins can be detected within 15 or 20 minutes of injury. Use of the blood tests could begin as soon as this year. Diagnosing an individual with a concussion is sometimes a shot in the dark even for trained medical professionals, as symptoms aren't always apparent and reliable tests like CT scans are incredibly costly and time-consuming. If a blood testing option is available, and given the lack of discernible lesions concussion patients may have, the test may be a preferred option combined with the Glasgow Coma Scale versus a CT scan.

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.

Traumatic brain injuries contributed to about 2.8 million emergency room visits and almost 50,000 deaths in 2013, according to data from the Centers for Disease Control and Prevention. It is manufactured by Banyan Biomarkers Inc., in Alachua, Florida.

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"Availability of a blood test for concussion will help healthcare professional determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients", officials wrote.

The Banyan Brain Trauma Indicator will show markers that indicate a person really needs a CT scan, which means that it will precede a CT scan unless the person shows signs of extreme trauma. But Wednesday's green light by the Food and Drug Administration "is a big deal because then it opens the door and accelerates technology", said Michael McCrea, a brain injury expert at Medical College of Wisconsin.

The Brain Trauma Indicator was assessed under the FDA's De Novo premarket survey pathway, an administrative pathway for some low-to direct hazard gadgets that are novel and for which there is no earlier legitimately showcased gadget. He was not involved in the development of the test. Now, for the first time ever, the FDA has approved a new type of blood test that can detect a concussion with incredible accuracy, and faster than ever before.

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