US-based biotech company, Banyan Biomarkers, Inc. has developed the first blood test that can be used by physicians to objectively aid in the evaluation of patients with suspected traumatic brain injury (TBI) or concussions.
The Banyan Brain Trauma Indicator® (Banyan BTI™) consists of two diagnostic test kits, Banyan UCH-L1® Kit and Banyan GFAP® Kit, which measure two specific protein biomarkers that rapidly appear in the blood after a brain injury.
According to the developers, the Banyan BTI can be used to rule out the need for a head CT scan in patients 18 years of age and older with a suspected TBI.
This blood test could play an important role in public health where there’s a need to reduce the number of unnecessary CT scans and their associated costs, particularly among those with mild concussions.
Banyan Biomarkers recently announced the publication of the results for the ALERT-TBI study, an international, multicentre clinical trial utilising the Banyan BTI. The results, which were published in The Lancet Neurology, support the clinical role of the biomarker test for ruling out the need for a head CT scan among emergency department TBI patients who would normally receive a head CT scan.
The ALERT-TBI study enrolled patients at 22 independent clinical sites in the US 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.
In February 2018, the US Food and Drug Administration (FDA) granted marketing authorisation to Banyan Biomarkers for the commercialisation of Banyan BTI to aid in the evaluation of patients with a suspected mild TBI or concussion. There is another biomarker, S100B, which has limited adoption in Europe but is not approved for use in the United States.
“This blood test meets an important public health need to reduce the number of unnecessary CT scans particularly among those with mild TBI who make up over 85% of all TBIs. In emergency medicine, CT scans are often used in evaluating these patients, even though fewer than 10% of scans reveal an abnormality,” said professor of Emergency Medicine and Neurology at The University of Rochester School of Medicine and principal investigator of the study, Jeff Bazarian, MD, MPH.
“This extensive clinical study shows that these two blood-based brain biomarkers can predict the absence of intracranial injury and reduce unnecessary head CT scanning, thereby reducing radiation exposure and healthcare costs while improving patient care and emergency department efficiency,” continued Bazarian.
Chairman and CEO of Banyan Biomarkers, Henry L. Nordhoff, added that the trial validated the ability of the Banyan BTI to rule out the need for head CT scan in patients with a suspected TBI within 12 hours after injury.
“The FDA reviewed and authorised for marketing the test in fewer than six months as part of its Breakthrough Devices Program. We are working closely with our commercial partners to make the test available in hospitals and emergency departments,” said Nordhoff.
The company is also engaged in additional TBI studies to evaluate the biomarkers in sports concussions, in adolescents and for monitoring recovery from brain injury.