FDA Grants Marketing Authorization to Banyan Biomarkers for the First Diagnostic Blood Test for Traumatic Brain Injury

Banyan BTI is the first in vitro diagnostic blood test to aid in the
evaluation of patients with suspected TBI, also known as concussion.

SAN DIEGO–(BUSINESS WIRE)–Banyan
Biomarkers, Inc.
, a pioneer in developing biomarkers for traumatic
brain injury (TBI), today announced that the U.S. Food and Drug
Administration (FDA) has granted the De Novo request for the
commercialization of Banyan BTITM (Brain Trauma Indicator),
an in vitro diagnostic blood test to aid in the evaluation of patients
with suspected TBI, also known as concussion. The FDA, in keeping with
its commitment to address urgent medical concern of brain injuries,
reviewed the test under the Breakthrough Devices Program, which is
intended to facilitate the development and expedite the review of
innovative breakthrough technologies. Banyan BTI identifies two
brain-specific protein biomarkers (Ubiquitin Carboxy-terminal
Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP)
that rapidly appear in the blood after a brain injury, providing
objective information to assess patients with suspected mild TBI. The
goal of the study was to identify patients with head trauma who could
safely forego the need for a CT scan thereby avoiding unnecessary
radiation to the brain and reduce costs of care.

“With extensive clinical research and scientific validation, Banyan BTI
has shown that these two specific protein biomarkers, which are released
from the brain and circulate in the blood after a brain injury, can
provide objective data to healthcare providers when evaluating patients
with a traumatic brain injury,” said Henry L. Nordhoff, Chairman and CEO
of Banyan Biomarkers. “Receiving marketing authorization from the FDA
for the first blood test for TBI is a significant milestone that will
transform how brain injury is managed. We are honored to have as our
partner, the U.S. Department of Defense and the U.S. Army Medical
Research and Materiel Command, for supporting the research and
development of a diagnostic test that now provides objective
quantifiable information to physicians, to eliminate unnecessary CT
scans, and guide patient care.”

Automobile accidents, falls, sports-related injuries, assaults, and, in
the military, improvised explosive devices (IEDs) and combat wounds are
common causes of TBI. The U.S. Center for Disease Control estimates
there are more than 2.5 million emergency room visits in the United
States as a result of head injuries and TBI is an economic burden of
more than $76 billion annually on the healthcare system.1
Traumatic brain injury is the leading cause of disability and the number
one cause of death for young adults.2

“The impact of traumatic brain injuries is felt within each branch of
the service and throughout the Department of Defense, and were even
considered the ‘signature wound’ from recent conflicts,” said Lt. Col.
Kara Schmid, Project Manager for the Neurotrauma and Psychological
Health Project Management Office for the U.S. Army Medical Materiel
Development Activity. “Finding solutions for the diagnosis and
evaluation of mild TBI has been a top priority for over a decade now.
Obtaining FDA authorization for the first objective blood-based
biomarkers of mild TBI is a huge success for the TBI community. This
assay will provide a remarkable capability for the way we evaluate and
care for our service members with TBI.”

Currently, the CT scan is routinely used to assist physicians in the
evaluation of TBI. However, the use of CT scans is highly variable
especially in the face of significant trauma with minimal symptoms.
Lacking an approved biomarker to guide decision making, the default for
physicians was to obtain a CT scan. More than 90 percent of patients
presenting to the emergency department with mild TBI or concussion, have
a negative CT scan.

“Brain biomarkers will change the practice of emergency care for mild
TBI and will greatly assist a large number of patients. The impact will
be improved medical care by reducing radiation exposure to the patient
and improving efficiency in the emergency department,” stated Andy
Jagoda, MD, Professor and Chair in the Department of Emergency Medicine
at the Icahn School of Medicine at Mount Sinai.

The FDA granting of the De Novo request for Banyan BTI also creates a
classification regulation for devices of this type and permits this
diagnostic test to serve as a predicate device. The FDA granting was
supported by a prospective multi-center pivotal study. The study called
ALERT-TBI, enrolled 2,011 patients at 24 independent clinical sites in
the United States and European Union and compared the test’s results to
head CT scans of patients presenting to emergency departments with
suspected head injury. The study showed that Banyan BTI achieved high
sensitivity and high NPV (negative predictive value) for ruling out the
need for a head CT scan and provides objective data for healthcare
providers to aid in the evaluation of patients with suspected TBI. The
company is engaged in additional studies to determine if the biomarkers
have applications in monitoring recovery after injury as well as their
application in other degenerative conditions of the brain.

The development of Banyan BTITM was
supported by the U.S. Army Medical Research and Materiel Command under
Contract No. W81XWH-10-C-0251. Any views, opinions, conclusions, and/or
findings contained in this press release are those of Banyan Biomarkers,
Inc. and should not be construed as an official Department of the Army
position, policy, or decision, unless so designated by other
documentation.

1 CDC https://www.cdc.gov/traumaticbraininjury/severe.html
2
CDC
www.cdc.gov/traumaticbraininjury/get_the_facts.html

About Banyan Biomarkers

Banyan Biomarkers, Inc. has developed the first blood test, Banyan BTI™,
that can be used by physicians to objectively aid in the evaluation of
patients with suspected traumatic brain injury (TBI), also known as
concussions. Banyan BTI consists of two test kits (Banyan UCH-L1®
Kit and Banyan GFAP® Kit) that measure two specific protein
biomarkers that rapidly appear in the blood after a brain injury. To
learn more about the Company and Banyan BTI, visit www.banyanbio.com.

Banyan Biomarkers, Banyan, Brain Trauma Indicator, BTI, Banyan UCH-L1,
Banyan GFAP, and the brain and tree logos are the trademarks and
copyrights of Banyan Biomarkers, Inc.

Contacts

Banyan Biomarkers, Inc.
Tony Grover
Vice President of Business
Development
tgrover@banyanbio.com
+1
(760) 710-0423
or
Little Dog Communications Inc.
Jessica
Yingling, Ph.D.
President
jessica@litldog.com
+1
(858) 344-8091