Anatomy of a Discovery
Experts cross disciplines to enable the rapid diagnoses of mild traumatic brain injuries at risk for serious, long-term effects.
Brain Injuries Decoded
Several million new mild traumatic brain injuries occur each year in the United States, mostly because of falls, auto accidents, and sporting mishaps. Many patients with the condition will heal quickly, but others may develop prolonged and disabling physical and emotional symptoms. Patients at risk for more serious effects from their injury must be identified quickly, to ensure the best outcome possible.
In 2018, an interdisciplinary team joined to create BRAINBox, a handheld device that enables a blood-based test to be administered directly at the point of care, providing rapid results. The test also aims to provide short- and long-term prognoses, including identifying early those at risk for prolonged or severe effects from their injury.
Timeline
November 2012
The Richmond, Virginia–based diagnostics firm ImmunArray licenses a panel of brain injury markers developed by Johns Hopkins University researchers Jennifer Van Eyk (now at Cedars-Sinai Medical Center) and Allen Everett.
January 2014
ImmunArray receives a $300,000 grant from the GE NFL Head Health Challenge to further develop the Johns Hopkins panel of brain injury markers.
December 2018
ImmunArray spins off a new company, BRAINBox Solutions, Inc., to commercialize tests for diagnosing and monitoring mild traumatic brain injury.
Virginia Catalyst awards a $500,000 competitive grant to a collaborative bioscience commercialization project including a team from the Virginia Tech Carilion Research Institute (now the Fralin Biomedical Research Institute at VTC), the University of Virginia, Carilion Clinic, and BRAINBox Solutions.
June 2019
The U.S. Food and Drug Administration grants BRAINBox Solutions a breakthrough designation for it first-of-kind device to aid in the diagnosis and prognosis of concussions. Virginia Tech, with the Fralin Biomedical Research Institute and its clinical partner, Carilion Clinic, serves as one of the national anchor research and clinical sites to validate the test. Faculty members with the University of Virginia Health System perform parallel diagnostic blood tests, neuroimaging, and neuropsychological studies.
September 2019
The U.S. Patent and Trademark Office expands BRAINBox Solutions’ patent on its multi-modality approach by adding a portfolio of biomarkers that have characteristics for diagnostics, such as robust levels in concussion and mild traumatic brain injury, extended kinetic profiles after injury, and a strong correlation to subtle microvascular injuries that are more difficult to assess. The biomarkers are novel astrocyte-injury–defined biomarkers, including Aldolase C or a trauma-specific breakdown product of Aldolase C.
How Brainbox Works
A core component of the BRAINBox system is a blood-based biomarker test that can be administered in an emergency department, an urgent care center, a clinic, or even eventually a sports field to provide a rapid-result assessment of a mild traumatic brain injury and a prognostic view of a patient’s likelihood of post-concussive symptoms.
The system uses a multianalyte immunoassay to identify specific proteins that have leaked from injury-damaged cells in the brain. The patient’s blood sample is placed on a small cartridge, which is inserted into a handheld device that can rapidly measure molecules and identify the proteins that have been released.
The panel of biomarkers is then paired with a functional assessment on a tablet. The functional component stems from validated neuropsychiatric testing and cognitive assessments delivered through an artificial intelligence–driven algorithm.
The BRAINBox system integrates the biomarker data and the neurocognitive assessment to produce a single simple and easy-to-understand score. The integrated score appears within a half hour.
Clinicians can also conduct balance and coordination assessments to complement that score for a more complete diagnosis and prognosis.
BRAINBox’s Principal Collaborators
Stephen LaConte, Ph.D.
Associate Professor, Fralin Biomedical Research Institute at VTC
“One of BRAINBox’s goals is to go beyond diagnosing mild traumatic brain injuries and provide prognoses. We want to predict short- and long-term outcomes, including identifying those at risk early for prolonged or severe effects from their injury.”
Damon Kuehl, M.D.
Vice Chair of Emergency Medicine, Carilion Clinic
“These injuries are some of the most challenging to diagnose. Other than using a CT scan to look for bleeding and doing a basic assessment of ability to function when the patient presents, we still don’t have really good diagnostic tools to find out which patients will do poorly and which will be fine.”
Donna Edmonds
Chief Executive Officer, BRAINBox Solutions, Inc.
“This is a game changer. The brain is extremely complex, and to understand what is going on during a head injury requires a multi-biomarker, multi-modality approach.”
Michael Friedlander, Ph.D.
Executive Director, Fralin Biomedical Research Institute at VTC
“This research represents a collaboration of creative scientists and physicians who are committed to the power of large-scale, rigorous scientific testing to advance the diagnosis of mild traumatic brain injury.”