Banyan Readies For Pivotal Study Of Molecular Dx For Traumatic Brain Injury
This article was originally published in The Gray Sheet
Banyan Biomarkers blood-based assay works by detecting the presence of two proteins that only cross the blood-brain barrier if there’s been a brain injury. An IDE was filed July 2 and the firm hopes for PMA approval in 2014.
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The Banyan Brain Trauma Indicator is the first blood test for detecting concussions in adults to reach the US market and the second device to emerge from US FDA's Breakthrough Devices Program. While test-maker Banyan Biomarkers originally flirted with the PMA pathway, FDA swayed it to the de novo process, which the firm ultimately leveraged to gain the market go-ahead.
The workshop will evaluate potential diagnostics, development strategies and datasets for traumatic brain injury. Multiple firms are working to bring different technologies for concussion detection to market.
The Cleveland Clinic has identified seven up-and-coming device technologies that are likely to have major clinical impact and see near-term commercial success, as part of its annual “Top 10 Medical Innovations” list.