Conclusion

This BTI biomarker is likely to be aggressively marketed, as evidenced by boldly worded press releases such as, “Finally, A Blood Test for Traumatic Brain Injury.”⁶ Likewise, similarly favorable materials describing “the remarkable significance of such markers in assessing and managing neurotrauma” are added to the scientific literature through open-access review articles authored by Banyan’s founder.⁷

The molecular diagnostics market is measured in the tens of billions of dollars annually, and while there is every possibility such innovations will ultimately prove to add value, we ought to require a high bar of quality implementation data. Without demonstrating their value and safety in prospective, real-world use, these observational test characteristics are not nearly enough to justify considering the use of biomarkers in traumatic brain injury.

References

1. Papa L, Brophy GM, Welch RD, et al. 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. JAMA Neurol. 2016;73(5):551-560.
2. Evaluation of Automatic Class III Designation for Banyan Brain Trauma Indicator. FDA website. Accessed March 3, 2021.
3. Bazarian JJ, Biberthaler P, Welch RD, et al. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018;17(9):782-789.
4. Stiell IG, Wells GA, Vandemheen K, et al. The Canadian CT Head Rule for patients with minor head injury. Lancet. 2001;357(9266):1391-1396.
5. Sharp AL, Nagaraj G, Rippberger EJ, et al. Computed tomography use for adults with head injury: describing likely avoidable emergency department imaging based on the Canadian CT head rule. Acad Emerg Med. 2017;24(1):22-30.
6. Finally, A Blood Test for Traumatic Brain Injury. Abbot website. Accessed March 3, 2021.
7. Wang KKW, Kobeissy FH, Shakkour Z, et al. Thorough overview of ubiquitin C‐terminal hydrolase‐L1 and glial fibrillary acidic protein as tandem biomarkers recently cleared by US Food and Drug Administration for the evaluation of intracranial injuries among patients with traumatic brain injury. Acute Med Surg. 2021;8(1):e622.