BrainBox Seeks to Bring TBI Detection Test to Market

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 p...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news