UF 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 post on DisabledVeterans.org discusses traumatic brain injury and calls the blood test that indicates TBI created by UF startup & Sid Martin Biotech graduate Banyan Biomarkers “great news.”)
If you’re a veteran with a traumatic brain injury, or TBI, you know how frustrating it can be. With a range of types and severities, TBI is one of the most common military injuries, especially in the last two decades.
At higher severities, relearning everyday tasks can be difficult. At any severity, physical symptoms such as headaches, trouble sleeping, memory lapses and depressed mood are an unwelcome intrusion on everyday life and recovery.
The Defense and Veterans Brain Injury Center (DVBIC) reports that over 375,000 veterans have suffered a TBI since 2000, and that TBI is currently estimated to affect over 20,000 military personnel per year. Most of them are classified as “mild,” meaning the affected person had a concussion rather than a direct injury.
The US Food and Drug Administration (FDA) classified brain trauma assessment tests and endoscopic electrosurgical clip cutting systems as class II devices.
Both device classifications were established via the De Novo pathway based on FDA’s review of 2016 and 2017 requests from Ovesco Endoscopy AG and UF startup Banyan Biomarkers, respectively. These in turn allow for a device sponsor of a brain trauma assay or an endoscopic electrosurgical clip cutting system to use the 510(k) pathway.
(UF startup Banyan Biomarkers recently received FDA approval for its blood test that measures biomarkers that indicate traumatic brain injury. The blood test will streamline diagnoses, cut back on unnecessary CT scans, and should be available in about two years.)
Ron Hayes remembers the moment his career in neuroscience took a turn — from being a behind-the-scenes “bench scientist” to one deeply invested in clinical medicine.
He was observing comatose trauma patients in the hospital intensive care unit who were on ventilators. One mother was holding her vegetative son.
“I thought immediately of Michelangelo’s Pietà,” he said, recalling the famous statue of Mary holding a dying Jesus. “It just occurred to me that nothing that I was doing was going to help these people.”
Until then, Hayes had been doing preclinical rodent research on the chemical mechanisms of traumatic brain injury, or TBI, at the University of Florida’s McKnight Brain Institute in Gainesville.
You’re throwing a football around in the yard with your neighbors. While stretching out as far as you can to catch the pass, you slam your head hard against a pole going for the ball. Seeing stars and feeling confused, you take a seat. Wouldn’t it be nice if a test could say whether you have a brain injury?
Brain injuries can happen from a fall, while in combat or during training exercises. Thanks in part to research funded by the Defense Department and the Army, UF startup Banyan Biomarkers has created the first-ever brain trauma blood test. On Feb. 14, the Food and Drug Administration cleared marketing of the Banyan Biomarkers’ Brain Trauma Indicator
Imagine being able to detect a concussion inside of 30 minutes.
Imagine no further.
Pay attention, because this is important to the military, to all of humanity. And, in that this column appears in our sports pages, let’s just say it will in all probability become a groundbreaker involving football and the concussions that threaten the game’s foundation — and thus, of course, all contact sports.
The FDA has granted commercialization of the first blood test for mild traumatic brain injury (TBI), concussion in layman’s terms.
This is a big deal for UF startup Banyan Biomarkers, Inc., a diagnostic company that developed the test behind $100 million provided by the Department of Defense to rapidly diagnose concussions in the field.
There are millions of traumatic brain injury (TBI) – related emergency department visits in the U.S each year.
For each one of these visits, be it from a car crash or football tackle, a two part standard examination is done to test for TBI. First is the 15-point Glasgow Coma Scale (see details below in note #1) followed by a CT scan of the head to look for the presence of intracranial lesions.
The Food and Drug Administration (FDA) recently approved a blood test that may revolutionize the diagnosis of TBI. It’s called the Brain Trauma Indicator and is marketed by UF startup Banyan Biomarkers Inc.
UF startup Banyan Biomarkers, Inc., a pioneer in developing biomarkers for traumatic brain injury (TBI), announced that Herb Boyer, PhD, co-founder of Genentech, will serve on the Banyan Biomarkers’ Board of Directors. Dr. Boyer co-founded Genentech in 1976 and served as a director of the company until its 2008 acquisition by Roche. Dr. Boyer also served on the board of Allergan for 19 years.
The company also announced that Frédéric Sweeney, PhD, will be joining the Banyan Biomarkers’ Board of Directors. Dr. Sweeney currently serves as Vice President, Business Development & Strategic Alliances at bioMérieux S.A., has held senior executive positions at T2 Biosystems, Inc., Tornado Spectral Systems Inc. and started his career as part for Canada’s largest life science venture capital and private equity firm.
bioMérieux, a world leader in the field of in vitro diagnostics, and UF startup Banyan Biomarkers, an innovative biomarkers company developing blood tests capable of diagnosing traumatic brain injuries (TBI), have entered into a partnership. Under the terms of the agreement, bioMérieux takes an equity participation of about $7 million in Banyan Biomarkers and obtains the rights to commercialize Banyan’s proprietary tests worldwide for use in in vitro diagnostics, with preferred rights for its VIDAS® immunoassays range. In addition, the two companies will continue to explore co-development opportunities in the area of TBI and critical care.
According to the World Health Organization, an estimated 10 million people are affected annually by TBI. The burden of mortality and morbidity that this condition imposes on society makes TBI a pressing public health, medical problem and weighs heavily on healthcare costs. Banyan’s biomarkers have the potential to objectively diagnose TBI with a simple blood test and to help avoid unnecessary patient exposure to dangerous ionizing radiation. Both companies aim at bringing to clinicians the first FDA-approved blood-based automated test for TBI.