Prolight Diagnostics, a leader in point-of-care (POC) technology, today announces positive results from a collaboration with BRAINBox Solutions, a leader in multi-modality diagnostic and prognostic tests for traumatic brain injury (TBI). The analytic evaluation shows strong performance across a unique combination of three traumatic brain injury biomarkers, demonstrating the ease with which multiple novel markers can be transferred onto the Psyros uniquesingle-molecule-counting platform and reinforcing its potential to improve patient care for broad clinical use.
The findings align with earlier pre‑clinical data demonstrating Psyros’ ability to deliver laboratory‑grade performance, detecting biomarkers at extremely low concentrations within minutes using only a small sample. The study was fully funded by BRAINBox, headquartered in Richmond, Virginia.
Building on these results, Prolight and BRAINBox will now advance to the next phase of the BRAINBox‑funded programme, evaluating all three assays using a 260-patient sample bank. The samples are a subset of the more than 2000 available from BRAINBox’s ongoing, HeadSMART II pivotal clinical study of its diagnostic and prognostic test for mild TBI, BRAINBox TBI, to support submission to the US Food and Drug Administration for marketing clearance. The assay format uses Psyros’ multiplex‑enabled, dried‑reagent cartridge, supporting scalable, low‑cost manufacturing – an important advantage in TBI and other conditions requiring high-precision, multi‑analyte testing.
“We are very encouraged by the outcomes of this first assay evaluation with BRAINBox. The data reinforce the versatility of the Psyros platform and its ability to support multiple assay formats. With BRAINBox now fully funding the next 260‑patient assay study, we see strong validation of Psyros’ unique market potential,” said Ulf Bladin, CEO of Prolight Diagnostics. “In parallel, Prolight remains fully focussed on delivering our high-sensitivity troponin test, as we gear up for the clinical performance study.”
”We have been actively seeking a point-of-care platform capable of delivering the ultra-sensitive performance required for our multimodality TBI test suite of products which can support our broad strategy for diagnosis, prognosis and monitoring in all care environments across our patent protected full neurology test pipeline. These early results from this recently established collaboration suggest that the Psyros system meets – and may even exceed – our performance expectations and potentially accelerate the development and commercialization of our tests. The ability to measure multiple TBI biomarkers within minutes at the point-of-care has the potential to meaningfully enhance real-world assessment and clinical decision-making in brain-injury care. We look forward to progressing to the next phase of our collaboration,” said Donna Edmonds, CEO of BRAINBox.
Prolight continues to attract growing interest from global diagnostics companies, supported by Psyros’ competitive advantages: unprecedented detection limits, whole‑blood capability, rapid turnaround time, multiplex functionality and low-cost manufacturing.
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