BRAINBox Solutions announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its BRAINBox Traumatic Brain Injury (TBI) test that helps in diagnosis and prognosis of mild TBI.
The BRAINBox TBI test is a quantitative, multi-modality test that combines injury-related blood protein biomarkers with computerized neurological assessments.
In addition, its product 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.
The offering also includes a quantitative interpretation of test results derived from the measurements in combination with computerized neurological assessments.
The BRAINBox test, which is suitable for use in point-of-care or clinical laboratory settings, offers physicians with a single score incorporating the data from all the test components and additional data that will assist in guiding treatement. The test is advised for patients older than 18 years, treated by a hospital emergency department or urgent care centre.
BrainBox president and CEO Donna Edmonds said: “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.
“The breakthrough designation underscores the potential of BrainBox TBI to change clinical practice in concussion management and will accelerate our development program.”
BRAINBox has initiated a clinical study named HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma (HeadSMART II), designed to support US and international regulatory filings for marketing approval.
Principal investigator of the study professor W. Frank Peacock and Baylor College of Medicine emergency medicine department vice chair Henry J Taub said: “BRAINBox Solutions represents the promise of a potential game-changer for both clinicians and their patients.
“The ability to identify and objectively measure the spectrum of TBI has the potential to revolutionize the care of the more than 1 million Americans each year who suffer from this frequently catastrophic event.”