BioDirection is collaborating with CENTER-TBI, an EU initiative that aims to advance the care of patients with traumatic brain injury.
A recent study from UCSF suggests Abbott's blood-based i-Stat Alinity device may be able to identify TBI that isn't found by a CT scan.
The firms said that Bio-Techne's Ella platform provides the sensitivity needed to provide analysis of the Nf-L biomarker for neurodegenerative diseases.
The firm is validating a mild TBI biomarker-based diagnostic kit for use by paramedics, first responders, and other healthcare professionals.
The biomarkers — ubiquitin carboxyl terminal hydrolase-L1 and glial fibrillary acidic protein — can be detected in blood soon after a brain injury.
The Army previously awarded Abbott $11.3 million to develop a TBI test. Abbott has worked with DoD since 2014 to develop tests to help evaluate potential concussions.
The firm is developing tests combining biomarkers and other clinical measures to diagnose and monitor patients and identify those at risk of long-term effects.
A spin-out of the University of Geneva and Barcelona's Vall d’Hebron Research Institute, the company is focused on protein biomarkers for brain injury.
The study showed the test had a high negative predictive value, but critics cited a lack of data on cost and outcomes.
Pro-Lab will shepherd Medicortex's kit through the regulatory processes in Canada and the UK, as well as clinically validate it. It will have exclusive rights to sell the kit in the two nations.