US DoD tests Abbott mhealth tech for detecting brain damage
May 21, 2019
The US Department of Defense (DoD) is conducting a clinical trial of Illinois-based Abbott Laboratories’ mhealth point-of-care blood test technology that can assess brain injuries within minutes, using only a few drops of a patient's blood.
This is the next phase of partnership with the Transforming Research & Clinical Knowledge in Traumatic Brain Injury Network (Track-TBI Net), one of the largest traumatic brain injury (TBI) efforts of its kind.
"Traumatic brain injury is a significant health issue affecting both active service members and veterans, and we are committed to developing solutions for those impacted by brain injury," said Krista Caudle, project manager with the US Army. "Having a portable biomarker technology will give clinicians an objective measure of a soldier's brain injury in a matter of minutes and could potentially impact the care they receive when they are evaluated and treated."
More than 380,000 military members have sustained TBIs over the past 20 years. To help improve efforts around this complex injury, Abbott and the DoD began their work in 2014 to develop a portable blood test that helps assess concussions right by a person's side. As blood tests are relied on by healthcare providers to detect various conditions due to their objectivity and speed, there's been a growing need to develop a point-of-care blood test that could serve as a warning bell to clinicians that further evaluation is needed.
"Developing a blood test for the brain takes robust, proven data and collaboration among the best minds in academia, industry and the public service sectors," said Beth McQuiston, board-certified neurologist and medical director of Abbott. "This type of blood test could give clinicians more real-time, objective information about what's happening to the brain, so they can make timely, accurate decisions right at the point of care."
As a specialist in diagnostic point-of-care testing, Abbott has more than 120 scientists who are researching and developing its concussion assessment test for the next generation i-Stat Alinity system. The i-Stat system, which is already in use within the military as well as in hospitals globally, performs a number of common blood tests within minutes – at the bedside – and uses only two to three drops of blood.
The blood test under development by Abbott would measure two types of proteins – GFAP (glial fibrillary acidic protein) and UCH-L1 (ubiquitin carboxyl-terminal hydrolase L1) – that are released from the brain and into the blood when the brain is injured. Blood biomarkers, such as GFAP and UCH-L1, have been researched for more than a decade for their ability to help assess traumatic brain injury in the military and the general public.
A critical part of the Track-TBI research initiative is to evaluate the effectiveness of blood-based biomarkers to detect brain injury. Abbott and the DoD will work with researchers from Track-TBI for this clinical trial to analyse data collected from patients who come to top trauma centres across the USA.
Currently, the US Food & Drug Administration (FDA) has cleared a blood test that detects brain injury within 12 hours of injury. As part of this clinical trial, researchers will evaluate people with suspected TBI within 24 hours of injury and compare their blood test results against traditional clinical assessments, computerised tomography (CT) scans, magnetic resonance imaging (MRI) scans and clinical outcomes.
"Whether on the battlefield or in the emergency room, we need quick and accurate information to help assess a person who may have sustained brain injury," said Geoffrey Manley, principal investigator of Track-TBI and professor of neurosurgery at the University of California, San Francisco. "Our goal with this partnership is to validate the scientific rigor behind new technologies, like this blood test, and how they can help ensure the best care for our troops and patients."
Track-TBI Net us a collaborative research effort funded by the National Institute of Neurological Disorders & Stroke, the US DoD and US Army Medical Materiel Development Activity, with support from private and philanthropic partners. It evolved from the largest and most comprehensive precision natural history study of TBI ever conducted in the USA. The foundational observational study enrolled more than 3000 TBI patients.
Abbott's concussion assessment test is in development and is for research purposes only. It is not yet commercially available. Abbott's i-Stat Alinity is available outside of the USA but is not yet commercially available in the USA.