FDA Clears Whole Blood Test for TBI in Military Troops
A new blood test can detect TBI in veterans within 15 minutes.
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A new whole-blood test for assessing traumatic brain injury (TBI) in army troops has received US Food and Drug Administration (FDA) clearance.
"This milestone accomplishment demonstrates how Army medical developers can partner with industry to deliver solutions for frontline medical personnel caring for our injured service members," said US Army Brigadier general Edward H. Bailey, commanding general of the US Army Medical Research and Development Command (USAMRDC).
TBI refers to a stressful injury to the brain that is caused by an external force, such as a blow to the head. According to the Disabled American Veterans organization, most TBIs are caused by falls, vehicle crashes, explosions or impacts during military service. Department of Defence statistics show that ~500,000 US military members experienced a TBI from 2000–2023. Designing and developing a portable solution for detecting and assessing TBIs among service members – both domestically and internationally – is therefore a “top priority” for the US military health system.
The new test requires a venous blood sample that can be collected at the patient’s bedside. The sample is then inserted into a portable device to analyze the presence of two biomarkers: ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). A variety of robust observational studies have shown that these biomarkers have high diagnostic accuracy for identifying TBI patients who are likely to present with traumatic intracranial abnormalities on head computed tomography (CT) scans.
Results are available within 15 minutes, providing a clear advantage over previous tests that relied on plasma or serum samples, which must be sent to a laboratory for processing. As not all patients with suspected TBIs will require head CT scans, the test will prevent “unnecessary medical evacuations and improve TBI management in the field,” said US Army Lieutenant Colonel Bradley Dengler, neurosurgical consultant to the Office of the Surgeon General.
What is FDA clearance?
Before some Class I and most Class II medical devices can be marketed, their developers must file a premarket submission – a 510(k) submission – to the FDA. This submission must show that the device is safe and effective compared to a legally marketed device. If the 510(k) submission receives approval, the device earns FDA clearance and can be legally marketed.
The test can also be used to evaluate patients up to 24 hours post-injury. Dengler called it one of the “most significant steps forward” in the care of TBI patients in the last 20 years: “Given the large numbers of expected casualties with all severities of TBI in future large-scale combat operations, this test can help maintain combat power far forward by helping to eliminate unnecessary evacuations.”
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Subscribe for FREE"Additionally, and just as important given the limited number of neurosurgeons available in theater, ongoing research demonstrates that a future version of this test could be used to triage more severely injured patients, as the blood biomarker elevations correlate with the severity of their intracranial injuries," he continued. "This can help get the most severely injured service members to neurosurgeons faster and ultimately save lives."
This article is a rework of a press release issued by [name of institute]. Material has been edited for length and content.
