BRAINBox Solutions has received breakthrough device designation from the US Food and Drug Administration (FDA) for a test intended to help in diagnosis and prognosis of mild traumatic brain injury (TBI) or concussion.
Named BRAINBox TBI, the quantitative test leverages injury-related blood protein biomarkers along with computerised neurological assessments.
It comprises a multiplex, fluorescence immunoassay with an in-vitro diagnostic serum measurements panel that includes the Glial Fibrillary Acidic Protein (GFAP), Neuron Specific Enolase (NSE) and Neurogranin (NRGN) biomarkers among others.
Results derived from these measurements will be quantitatively interpreted in conjunction with the computerised neurological assessments.
BRAINBox TBI is designed to offer a single score with data from all the test components as well as additional data that could guide treatment decisions.
The test is meant for both point-of-care and clinical laboratory use in patients aged 18 years and above treated at a hospital emergency department or urgent care centre.
BRAINBox Solutions president and CEO Donna Edmonds said: “With more than five million patients in the US 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 programme.”
The company commenced the HeadSMART II clinical study of BRAINBox TBI to support regulatory filings for marketing approval in the US as well as international markets.
During the study, serial assessments will be collected across 20 sites in the US, UK and Australia over approximately 18-20 months. It will recruit patients in hospital emergency rooms and urgent care centre settings.
The study is designed to gather cognitive and neuropsychological test data required to analyse a patient’s cognitive state, along with the biologic response measured by biomarkers released upon injury.