New Blood Test Aids in Concussion Evaluation The U.S. Food and Drug Administration (FDA) recently authorized marketing of a new blood test that may prevent unnecessary radiation exposure in people suspected of having mild traumatic brain injury (mTBI). The Banyan Brain Trauma Indicator—reviewed and authorized under the FDA’s Breakthrough Devices Program—helps determine the need for a CT ... News in Brief
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News in Brief  |   May 01, 2018
New Blood Test Aids in Concussion Evaluation
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Attention, Memory & Executive Functions / Traumatic Brain Injury / News in Brief
News in Brief   |   May 01, 2018
New Blood Test Aids in Concussion Evaluation
The ASHA Leader, May 2018, Vol. 23, 10. doi:10.1044/leader.NIB1.23052018.10
The ASHA Leader, May 2018, Vol. 23, 10. doi:10.1044/leader.NIB1.23052018.10
The U.S. Food and Drug Administration (FDA) recently authorized marketing of a new blood test that may prevent unnecessary radiation exposure in people suspected of having mild traumatic brain injury (mTBI).
The Banyan Brain Trauma Indicator—reviewed and authorized under the FDA’s Breakthrough Devices Program—helps determine the need for a CT scan in patients with suspected mTBI (concussion).
Most patients evaluated for head injury are examined using a neurological scale (the 15-point Glasgow Coma Scale), followed by a head CT scan to detect brain tissue damage that may require treatment. However, most patients with concussion symptoms have a negative CT scan.
The availability of a blood test to detect mTBI “will likely reduce the CT scans performed on patients with concussion each year,” said FDA Commissioner Scott Gottlieb.
TBI-related emergency department visits, hospitalizations and deaths in the U.S. totaled 2.8 million in 2013, according to the U.S. Centers for Disease Control and Prevention. About 75 percent of TBIs that occur each year are mTBIs or concussions.
The Brain Trauma Indicator measures levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into the blood and measured within 12 hours of head injury. The test results, available in three to four hours, can help predict which patients may have intracranial lesions visible by CT scan and which don’t.
In a multi-center, prospective clinical study of almost 2,000 adults with suspected mTBI, the test predicted the presence of intracranial lesions on a CT scan 97.5 percent of the time and the absence of intracranial lesions on a CT scan 99.6 percent of the time.
These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can use it to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.
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May 2018
Volume 23, Issue 5