Therapy Areas: Devices
BRAINBox wins FDA's Breakthrough Device Designation for device to aid in concussion diagnosis
6 June 2019 -

Neurocognitive testing company BRAINBox Solutions reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Breakthrough Device Designation to speed the development of its BRAINBox TBI (Traumatic Brain Injury) test to aid in both the diagnosis and prognosis of mild TBI (concussion).

The BRAINBox TBI test, which is in development, is a multi-modality, quantitative test that combines injury-related blood protein biomarkers with computerized neurological assessments. The test is designed for patients 18 years or older who are treated by a hospital emergency department or urgent care centre. It provides physicians with a single score incorporating data from all the test components and additional data useful for guiding treatment.

According to the company, 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.

BRAINBox Solutions has also launched its clinical study, called HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma), which is designed to support US and international regulatory filings for marketing approval, across 20 sites in the US, UK and Australia.

Under HeadSMART II, the company is collecting extensive cognitive and neuropsychological test data critical to the assessment of each patient's cognitive state in addition to the biologic response measured by biomarkers that are released upon injury.