Clinical Studies

Banyan Biomarkers has a rich history in conducting and collaborating in clinical studies. We believe that partnering is an important aspect in identifying new biomarkers and treatments for the brain. If you are interested in working together, please contact us to further address brain injury and neurological diseases.

Year #of Subjects Manuscript Title Summary Journal Link
2018 2011 Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study The ALERT-TBI study enrolled patients at 22 independent clinical sites in the United States and Europe and compared the Banyan BTI test's results to head CT scans of patients presenting to emergency departments with suspected head injury. Analysis of 1,959 patients presenting with an initial Glasgow Coma Scale of 9-15 from the study showed that the Banyan BTI achieved high sensitivity (97.6%) and high negative predictive value (NPV) (99.6%) for ruling out the need for a head CT scan in these patients. LANCET Neurology View Resource
2017 167 Modeling the Kinetics of Serum Glial Fibrillary Acidic Protein, Ubiquitin Carboxyl-Terminal Hydrolase-L1, and S100B Concentrations in Patients with Traumatic Brain Injury GFAP concentrations increased 3.7% per hour among CT-positive patients whereas neither UCH-L1 nor S100B increased, compared with CT-negative patients. The kinetics and temporal profile of GFAP suggest it may be a more robust biomarker to detect patients with positive CT findings, particularly at later post-injury times. Journal of NeuroTrauma View Resource
2017 32 Prospective Assessment of Acute Blood Markers of Brain Injury in Sport-Related Concussion GFAP levels did not differ between groups or in concussed athletes relative to pre-season. This study provides prospective evidence of significant increases in serum levels of UCH-L1 and S100B during the early acute period following sports related concussion, and lays the foundation for future studies examining the clinical potential for blood-based biomarkers in the early detection of concussion. Journal of Neurotrauma View Resource
2016 584 Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury GFAP and UCH-L1 were detectible within 1 hour of injury. GFAP peaked at 20 hours after injury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at 8 hours after injury and declined rapidly over 48 hours. JAMA Neurology View Resource
2016 251 Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury UCH-L1 outperformed GFAP and S100B when the goal was to reduce CT use without sacrificing sensitivity. UCH-L1 values <40 pg/mL could potentially have aided in eliminating 83 of the 215 negative CT scans. Journal of Neurotrauma View Resource
2014 206 Acute Biomarkers of Traumatic Brain Injury: Relationship between Plasma Levels of Ubiquitin C-Terminal Hydrolase-L1 and Glial Fibrillary Acidic Protein (TRACK-TBI) The results demonstrate a role for multiple biomarker measurements in TBI research. Journal of Neurotrauma View Resource
2013 215 GFAP-BDP as an Acute Diagnostic Marker in Traumatic Brain Injury: Results from the Prospective Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study (TRACK-TBI) The results demonstrate that measurement of serum GFAP-BDP may improve the ability of clinicians to identify TBI patients who may require further medical evaluation and management. Use of GFAP-BDP as a serum biomarker for TBI should lead to more accurate diagnosis and management of TBI. Journal of Neurotrauma View Resource
2012 45 Brain injury biomarkers may improve the predictive power of the IMPACT Outcome Calculator Results underline the importance of biomarkers in outcome prediction, and encourage further investigation to expand the predictive power of contemporary outcome calculators and prognostic models in TBI Journal of Neurotrauma View Resource
2012 307 Elevated Levels of Serum Glial Fibrillary Acidic Protein Breakdown Products in Mild and Moderate Traumatic Brain Injury Are Associated With Intracranial Lesions and Neurosurgical Intervention GFAP-BDP is detectable in serum within an hour of injury and is associated with measures of injury severity, including the GCS score, CT lesions, and neurosurgical intervention Annals of Emergency Medicine View Resource
2012 295 Serum levels of ubiquitin C-terminal hydrolase distinguish mild traumatic brain injury from trauma controls and are elevated in mild and moderate traumatic brain injury patients with intracranial lesions and neurosurgical intervention UCH-L1 is detectable in serum within an hour of injury and is associated with measures of injury severity including the GCS score, CT lesions, and NSI Journal of Trauma View Resource
2011 248 Neuronal and glial markers are differently associated with computed tomography findings and outcome in patients with severe traumatic brain injury: a case control study Protein biomarker could provide better characterization of subjects at risk for specific types of cellular damage than that obtained with neuroimaging alone, as well as provide valuable information about injury severity and outcome after severe TBI Critical Care Medicine View Resource
2010 66 Ubiquitin C-terminal hydrolase is a novel biomarker in humans for severe traumatic brain injury UCH-L1 protein is present in human CSF and that its levels were significantly elevated after severe TBI using enzyme-linked immunosorbent assay (ELISA) analysis. UCH-L1 was detectable in CSF very early after injury and was associated with measures of injury severity and outcome Critical Care Medicine View Resource