TRACK-TBI NET selected as research network for BARDA-sponsored trial of Abbott TBI Aid-In-Diagnosis Trial

BARDA is partnering with Abbott to broaden the company’s current traumatic brain injury (TBI) test that will aid healthcare providers in diagnosing and determining severity of TBI in adults and children.

TBI is a significant injury seen in over 5 million patients annually during standard emergency care and is a major clinical consequence resulting from mass casualty incidents, as well as everyday accidents. The National Academies of Sciences, Engineering, and Medicine have identified TBI as an injury of significant concern with long-term impact. The time from injury to treatment is critical and patients are often directed to imaging procedures for diagnosis such as CT and MRI scans. With few objective diagnostic evaluation tools beyond a CT scan, and the inability to quickly and definitively map severity, there is much variability in the triage of patients that may result in treatment bottlenecks and delays in the delivery of care for severe cases. Such challenges would be exacerbated in a mass casualty scenario.

To further bolster U.S. preparedness for trauma care, BARDA will support Abbott in expanding the indications for use of a simple blood test for specific biomarkers, GFAP and UCH-L1, that are associated with brain injury. Detection of these biomarkers will occur on a core laboratory instrument that can run hundreds of tests with high throughput. As a diagnostic aid, the levels of these biomarkers could help inform triage and treatment decisions by providing clinicians with an objective assessment of the severity of the injury and potentially the expected course of recovery. Further, this test would be among the first biomarker tests to objectively evaluate TBI in children.

Abbott will work to integrate this TBI test as a standard diagnostic panel for trauma care within the U.S. healthcare system. BARDA and Abbott will partner with key clinical leaders, including the Translating Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research network to evaluate the benefit of using this TBI blood test in clinical care.

If developed successfully, this TBI test would help providers quickly screen large numbers of people and may aid in the triage of patients to deliver appropriate and targeted care to patients in need. A focus on commercial integration as part of this joint BARDA-Abbott investment will help ensure the commercial sustainability of the TBI test as well as broad availability during a mass casualty incident.