TED Initiative Receives FDA Letter of Support for Biofluid Biomarkers

On January 10, 2018, the TED Initiative, along with TRACK-TBI, received an FDA Letter of Support (LOS) to encourage the further study of blood levels of glial fibrillary acidic protein (GFAP), a biomarker of astrocytic injury and ubiquitin carboxyl-terminal hydrolase-L1 (UCH-L1), a biomarker of neuronal injury, as exploratory prognostic enrichment biomarkers to identify patients who are at risk for having poor functional outcome during the course of TBI clinical trials. Issued by FDA's Office of New Drugs, the LOS highlights the FDA’s endorsement of our approach to leveraging data across studies, paying particular attention to the use of data standards, data sharing, and analytic processes. This complements the LOS received last year to explore neuroimaging prognostic biomarkers. To date, these are the only two Letters of Support issued by FDA related to traumatic brain injury.

Download Letter of Support