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BioDirection Inks Agreement With EU-Backed Alliance for Concussion Test Evaluation, Development

NEW YORK – BioDirection today announced that it has inked a multiphase technical collaboration agreement with Antwerp University Hospital in Belgium for the evaluation and development of its Tbit concussion testing system, which it is developing to provide results in less than 90 seconds from a single drop of blood.

Antwerp University Hospital is the coordinator of CENTER-TBI, short for Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury, a collaborative initiative supported by a European Union grant that aims to advance the care of patients with traumatic brain injury.

Financial and other terms of the agreement were not disclosed.

Andrew Maas, co-chairman of the CENTER-TBI management committee, said in a statement that early and rapid diagnosis of TBI is critical, but only core laboratory tests that often require three to four hours or more to provide results are available to diagnose TBI. "BioDirection's rapid point-of-care platform could address this urgent, unmet market need, both in and out of the medical center environment," Mass said.

Tbit — short for traumatic brain injury test — leverages nanowires functionalized with monoclonal antibodies to measure the levels of two proteins — glial fibrillary acidic protein, or GFAP, and S100 beta — which have been shown to increase in blood after traumatic brain injuries.

Sharad Joshi, president and CEO of Boston-based BioDirection, said that the "Tbit System provides a cost-effective platform readily adaptable to include any biomarker which will provide clinicians with research tools for expanding early diagnosis to effectively address the issues of injury stratification, prognosis, and return to activity following recovery."

The CENTER-TBI project includes a large-scale observational study, which initially involved 65 medical centers in 20 EU countries and was later supplemented by non-EU-based medical centers in China, Australia, and India. The CENTER-TBI Core Study has collected detailed clinical and neuroimaging data and blood samples from around 4,550 patients in Europe and Israel.