Business Wire

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

Del

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 BTI TM 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.

Contact information

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

American Airlines Announces Nonstop Philadelphia (PHL) to Orlando Melbourne (MLB)21.9.2018 22:13Pressemelding

Glorious beaches by day and theme park fireworks by night just got more convenient for Philadelphia travelers. American Airlines announced today that it will begin nonstop flights to Orlando Melbourne International Airport (MLB) starting February 16, 2019. The Central Florida airport is conveniently located in the heart of the tourism region and is the closest airport to NASA rocket launches, Port Canaveral’s cruises and what critics call “some of the most beautiful beaches Florida has to offer.” The flights will depart Saturdays from Philadelphia at 8:05 a.m., arriving in Florida at 10:48 a.m. The Embraer 175 jet arrival time syncs perfectly with cruise ship noon early boarding. Melbourne Airport Express offers nonstop shuttle service to the port, and all major rental car companies are onsite. The return flight to PHL departs at 11:24 a.m. and arrives in PHL at 1:55 p.m., with enough time to connect to some of American’s largest international destinations, including recently announced

Amy Palladino Joins BCW as Executive Vice President, Managing Director, Corporate Practice21.9.2018 17:43Pressemelding

BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Amy Palladino has joined the agency as Executive Vice President, Managing Director in the agency’s U.S. Corporate Practice. Based in New York, Palladino will focus on senior client counsel and executive positioning for the agency’s largest corporate clients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005507/en/ Amy Palladino Joins BCW (Burson Cohn & Wolfe) “Amy is a talented and highly experienced communications executive with a track record of solving clients’ complex challenges and building business through smart, integrated communications approaches,” said Chris Foster, President, North America, BCW. “Her creativity and judgement will be enormously valuable to our current and prospective clients.” Palladino has more than 20 years of experience advising global clients across numerous industries, including technology, healthcar

Heidelberg Engineering Announces the CE-Marking of ANTERION21.9.2018 16:41Pressemelding

Heidelberg Engineering, the leader in diagnostic imaging known for the internationally-acclaimed SPECTRALIS ® retina and glaucoma platform, announces the CE-marking of ANTERION ® – an innovative platform designed to transform anterior segment diagnostics and workflow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005442/en/ The new Heidelberg Engineering ANTERION® provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. (Graphic: Business Wire) The new ANTERION provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. It is a single, workflow-efficient solution that brings together corneal topography and tomography, anterior segment metrics, axial length measurement and IOL calculation to transform the day-to-day routine of busy practices and clinics. Heidelberg Engineering has leveraged its core OCT technolo

Florian Winterstein Becomes New CEO of Jedox21.9.2018 15:46Pressemelding

The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it

Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 13:30Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+

Asda Selects HCL Technologies to Help Drive IT Transformation21.9.2018 12:16Pressemelding

HCL Technologies (HCL), a leading global technology company, today announced that it has been selected to help drive IT transformation at the UK’s third-largest grocery retailer, Asda. The three-year application services contract will see HCL transform Asda’s IT Application Services with a new DevOps delivery model to drive data and analytics and support back-office applications through the full lifecycle of development, testing and support. HCL will also build a central data management platform to enable Asda to improve its insight and analytics capabilities. Asda operates more than 600 stores across the UK, employing over 135,000 people. Asda wanted to adopt a more agile approach towards application development and testing. This would allow the company to respond faster to business requirements and reduce time to market, while driving better user experience and satisfaction. HCL was selected due to its extensive expertise in successfully delivering similar large scale IT transformati