BrainBox Solutions is the latest company to develop a product for the traumatic brain injury (TBI) detection market. FDA has recognized the Richmond, VA-based company’s efforts and has granted breakthrough device designation for the BrainBox TBI test.
The firm said the product is a multi-modality, quantitative test that combines injury-related blood protein biomarkers with computerized neurological assessments.
The BrainBox TBI test is composed of a multiplex, fluorescence immunoassay using a panel of in-vitro diagnostic serum measurements, including the biomarkers Glial Fibrillary Acidic Protein (GFAP), Neuron Specific Enolase (NSE), Neurogranin (NRGN) and others, and a quantitative interpretation of test results derived from these measurements in conjunction with computerized neurological assessments.
The BrainBox test, for use in point-of-care or clinical laboratory settings, provides physicians with a single score incorporating the data from all the test components and additional data useful for guiding treatment. The test is designed for patients 18 years or older who are treated by a hospital emergency department or urgent care center.
"With more than 5 million patients in the U.S. each year evaluated for mild TBI in hospital emergency departments, there is an enormous need for better tools to objectively diagnose and manage this condition," Donna Edmonds, president and CEO of BrainBox, said in a release. "The breakthrough designation underscores the potential of BrainBox TBI to change clinical practice in concussion management and will accelerate our development program."
In addition, the company announced the initiation of its clinical study, named HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma), which is designed to support U.S. and international regulatory filings for marketing approval. The study, which is expected to take 18 to 20 months, includes serial assessments collected across 20 sites in the U.S., U.K. and Australia.
Other TBI Efforts
A little more than a year ago, FDA granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator (BTI). The San Diego-based company’s test identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP) that rapidly appear in the blood after a brain injury.
In April of 2018, Jan Medical teamed up with the U.S. Army Medical Material Agency to get an indication for its BrainPulse test to detect brain disorders and injury, including concussions.