Brain-injury diagnostic dev BrainBox Solutions said today that the FDA granted it a breakthrough device designation for its in-development BrainBox Traumatic Brain Injury test and that it launched a pivotal trial of the system.
The Richmond, Va.-based company’s BrainBox TBI test is a multi-modality, quantitative test combining injury-related blood protein biomarkers with computerized neurological assessments.
The test is composed of a multiplex, fluorescence immunoassay that uses a panel of in-vitro diagnostic serum measurements, including a number of specific biomarkers, and a quantitative interpretation of test results derived from those measurements alongside computerized neurological assessments.
The test is intended for patients 18 years and older and is usable at the point-of-care or in a clinical laboratory, BrainBox 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,” prez & CEO Donna Edmonds said in a press release.
BrainBox added that it has launched a pivotal clinical study of the BrainBox looking to support U.S. and international regulatory filings for marketing approval. The company expects the trial to take 18 to 20 months, and said that it will look to enroll patients in hospital emergency rooms and urgent care center settings.
“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,” study principal investigator Dr. W. Frank Peacock of Houston’s Baylor College of Medicine said in a prepared statement.
