FDA approves the first blood test to diagnose concussion

March 11, 2018

The news headlines are filled with stories of professional football players suffering from brain damage, but you do not to have to participate in sports to sustain a concussion – it is an everyday occurrence. In the US, in 2013 there were 2.8 million concussion-related emergency room visits and hospitalizations with 50,000 people dying from brain injuries. Three out of four concussions are mild. However, even mild concussion can cause impaired thinking or memory, poor concentration and emotional problems.

The U.S. Food and Drug Administration has recently approved the first blood test to evaluate concussion in adults. The diagnosis of concussion or in medical lingo, mild traumatic brain injury (mTBI), has been based purely on the description of symptoms by the patient, neurological examination, including the 15-point Glasgow Coma Scale, and brain imaging, such as CT scan to detect brain damage or bleeding. The majority of patients with a concussion have normal MRI and CT scans. This new blood test will help health care providers decide if a CT scan is necessary. This will avoid unnecessary scans which expose patients to radiation. It should also save money.

The Brain Trauma Indicator developed by Banyan Biomarkers, Inc. 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. Levels of these blood proteins after mTBI can help predict which patients may have brain lesions visible by CT scan and which won’t. Test results can be available within 3 to 4 hours.

The FDA based their approval on the data from a study of 1,947 patients with a suspected concussion. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time.

It is not clear how this test will be used in the real world. If someone is sick enough to be brought to an ER, they are likely to get a CT scan, which is faster and avoids the 3-4 hour wait for the blood test results and the added cost of the blood test. People with a mild concussion who are not taken to an ER will not need the test because they are very unlikely to have visible brain injury on the CT scan. If symptoms persist for a while and the patient comes to our headache clinic, we obtain an MRI scan, which is more informative and avoids radiation, although it is more expensive.

Written by
Alexander Mauskop, MD
Continue reading
November 15, 2025
Cluster headaches
Cluster headaches and solar activity
It was an unusual week at the New York Headache Center. After months of relative calm, my schedule suddenly filled with cluster headache patients—one even consulting me virtually from Saudi Arabia. The influx came right after a G5-level geomagnetic storm, one of the strongest solar events in recent memory.
Read article
November 10, 2025
Alternative Therapies
A Week of Meditation Changes Brains and Bodies
A week-long meditation retreat produces dramatic changes in brain and metabolic functions
Read article
October 21, 2025
Alternative Therapies
Meditation is better than slow breathing exercise in reducing pain
A new study published in the journal PAIN by Dr. A. Amorim and her colleagues at the University of California San Diego examined how mindfulness meditation reduces pain. The findings help clarify whether mindfulness meditation is more effective than simple slow breathing for pain relief.
Read article