BRAINBox solutions launched first of its kind breakthrough device to aid in the diagnosis and prognosis of mild Traumatic Brain Injury (TBI).
The BRAINBox TBI test is multi-modality, quantitative test that combines injury-related lifeblood protein biomarkers with computerised neurological assessments.
The test is composed of a multiplex, fluorescence immunoassay using panel of in-vitro diagnostic serum measurements, including the biomarkers Glial Fibrillary Acidic Protein (GRFAP), Neuron Specific Enolase (NSE), Neurogranin (NRGN) and others, and a quantitative interpretation of test results derived from these measurements in conjunction with computerised neurological assessments.
BRAINBox announced the initiation of its clinical study, HEAD SMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma), designed to support the US and international regulatory filings for marketing approval.
The course of study is expected to take 18-20 months, includes serial assessments that are collected across 20 sites in the US, UK and Australia.
Based upon the data and history of HeadSMART, its first mild traumatic brain injury study produced several publications, it will enrol patients in hospital emergency rooms and urgent care centre settings.
FDA has granted a breakthrough device designation for the first of its kind diagnosis of mild TBI.