by Ashley Jordan Ferira, PhD, RDN
As part of its Breakthrough Devices Program, the FDA authorized marketing for the Brain Trauma Indicator, the first blood test to evaluate mild traumatic brain injury (TBI) in adults.1
What is TBI?
TBI, also known as “concussion,” occurs following a bump, blow or jolt to the head or penetrating head injury that disrupts the brain’s normal functioning. TBI can cause short- and long-term impairments in thinking, memory, movement, sensation (e.g. vision or hearing) and emotional functioning.2
How common are TBIs?
Falls are the leading cause of TBI, resulting in 2.8 million emergency room visits, hospitalizations and deaths in the US and claiming the lives of 50,000 people annually. While TBI can range from mild to severe, 75% of TBIs are mild (mTBIs).2
What is the current, diagnostic standard of care for suspected TBI?
Patients with suspected head injury are examined using the 15-point Glasgow Coma Scale, followed by a head computed tomography (CT) scan to assess for brain tissue damage or intracranial lesions. The majority of patients with mTBI symptoms have a negative CT scan.1
Why is a blood test for mTBI valuable?
A quick, accurate blood test enables health care professionals to efficiently and reliably determine the need for CT scans in patients with suspected mTBI, thereby helping to reduce unnecessary neuroimaging and prevent associated radiation and healthcare costs.1
How does the Brain Trauma Indicator (Banyan Biomarkers, Inc.) blood test work?
This blood test measures circulating levels of two neuro-biomarkers, glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase isozyme L1 (UCH-L1), which the brain releases into the blood within 12 hours of head injury. GFAP and UCH-L1 levels are used to identify and stratify the severity of brain injury and have been shown to strongly correlate with long-term clinical TBI outcomes.3 Test results can be available within 3-4 hours.
What is the evidence basis for the Brain Trauma Indicator blood test?1,3-5
A large multi-center, prospective clinical study in adults with suspected mTBI was the basis for FDA clearance, and a robust body of literature supports the use of GFAP and UCH-L1 in the diagnosis of mTBI.3-5 The Brain Trauma Indicator correctly predicts the presence and absence of intracranial lesions on CT 97.5% and 99.6% of the time, respectively, which is expected to rule out the need for CT in at least one third of patients with suspected mTBI. The FDA reviewed and authorized the test in fewer than 6 months.1
Why is this Clinically Relevant?
- TBI is common and is associated with significant morbidity and mortality
- The majority of patients with mTBI symptoms have a negative CT scan
- The Brain Trauma Indicator blood test aids practitioners in concussion evaluation, helping them predict which patients with mTBI symptom presentation will benefit from a CT scan, thereby reducing unnecessary radiation exposure from head CTs
- The convenience and speed of this mTBI blood test improves patient care for the American public, as well as for our domestic and international military service members
Reference
Citations
- USDHHS. FDA News Release. FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596531.htm. Accessed February 27, 2018.
- CDC. TBI: Get the Facts. https://www.cdc.gov/traumaticbraininjury/get_the_facts.html. Accessed March 9, 2018.
- Jones A, Jarvis P. Review of the potential use of blood neuro-biomarkers in the diagnosis of mild traumatic brain injury. Clin Exp Emerg Med. 2017;4(3):121-127
- Papa L, Brophy GM, Welch RD, et al. Time course and diagnostic accuracy of glial and neuronal blood biomarkers GFAP and UCH-L1 in a large cohort of trauma patients with and without mild traumatic brain injury. JAMA Neurol 2016;73(5):551-560.
- Lewis LM, Schloemann DT, Papa L, et al. Utility of serum biomarkers in the diagnosis and stratification of mild traumatic brain injury. Acad Emerg Med. 2017;24(6):710-720.
