FDA Grants Marketing Authorization to Banyan Biomarkers for the First Diagnostic Blood Test for Traumatic Brain Injury
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.
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.
Banyan Biomarkers, Inc.
Vice President of Business Development
+1 (760) 710-0423
Little Dog Communications Inc.
Jessica Yingling, Ph.D.
+1 (858) 344-8091
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Manchester United Shoots for Success with a “Digital Experience Platform” Powered by HCL16.8.2018 22:02 | Tiedote
Manchester United (NYSE:MANU) has today announced a major milestone on its digital transformation journey with HCL Technologies, with the successful launch of the Manchester United Official app powered by HCL’s digital experience platform. The launch is part of the ongoing digital transformation of the club to provide a real-time, engaging, personalized, and unified experience to Manchester United’s 659 million global followers, which supports the club’s strategy to become a Digital Sports Enterprise. At the heart of this transformation is the digital platform developed by HCL, providing the club with a single view of fans across web and app touchpoints, offering fans a one-stop shop for everything Manchester United. Manchester United’s Group Managing Director Richard Arnold comments: “This app will allow our 659 million Manchester United followers to easily connect to the club they love, wherever they are in the world. Fans will now have the opportunity to follow all Manchester United
4K 4Charity Fun Run Announces Open Registration for IBC201816.8.2018 20:41 | Tiedote
AWS Elemental, an Amazon Web Services (AWS) company, today announced that the fifth annual 4K 4Charity Fun Run at IBC Show will take place at 7:00 a.m. local time on Saturday, Sept. 15 at Amstelpark in Amsterdam. Registration is open at https://4k4charity.com/ibc. Among the non-profits supported by the 4K 4Charity Fun Run at IBC Show is Amsterdam-based StichtingNewTechKids, which provides computer science education for girls, minorities, and economically challenged youth in the Netherlands. The organization supports a computer science teacher training program for primary school teachers with proceeds from 4K 4Charity. Also supported is Iridescent, a global education non-profit that empowers underrepresented young people to become innovators and leaders through engineering and technology. Through their two programs, Curiosity Machine AI Family Challenge and Technovation, Iridescent introduces underserved communities to new technologies and empowers and equips them to apply those technol
2018 D.I.C.E. Cannes Announced Round 3 Speakers16.8.2018 17:01 | Tiedote
The Academy of Interactive Arts & Sciences’ D.I.C.E. Cannes event will take place 9-11 September 2018 at the Hotel Barrière Le Majestic Cannes in France. Leading video game executives will participate in the premier networking opportunities, listen to key speakers address the conference theme - Trailblazers - to tackle some of the industry’s biggest ideas and trends. Newly announced speakers include: Craig Duncan, Studio Head at Rare – Duncan will share his studio’s experience and learnings with “A Rare Voyage of Adventure.” Duncan will provide insight into Rare’s bold new IP Sea of Thieves, a game that has inspired friendships and players creating stories together. David Hubert, Animation and Cinematic Director at Eidos Montreal – In Hubert’s talk he will discuss how cinematics are redefining AAA story-driven games and how they will continue to shape the medium to push the envelope throughout the production process. Adam Orth – In a session titled “Digging for Fire: Virtual Reality 20
GN Hearing and Google Announce Partnership to Bring Direct Mobile Streaming from Android Devices to Hearing Aids16.8.2018 16:00 | Tiedote
GN Hearing and Google have today announced a new technology partnership that will make GN Hearing the first manufacturer to enable a full spectrum of direct audio streaming from Android devices to hearing aids. The expectations are that direct streaming will become available to hearing aid users of the recently launched hearing aids ReSound LiNX Quattro™ and Beltone Amaze™ in a future Android release. “According to the World Health Organization, around 466 million people worldwide have disabling hearing loss. This number is expected to increase to 900 million people by the year 2050. Google is working with GN Hearing to create a new open specification for hearing aid streaming support on future versions of Android devices,” states Seang Chau, Vice President of Engineering at Google. Users will be able to connect and monitor their hearing aids, so they can get the full advantages of their Android devices without using an intermediate device for streaming to their hearing aids. This will
Zurich Expands Global Use of Guidewire InsurancePlatform with Selection of Guidewire Cyence Risk Analytics16.8.2018 15:55 | Tiedote
Guidewire Software, Inc. (NYSE: GWRE), the provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Zurich Insurance Group (Zurich) has selected Guidewire Cyence™ Risk Analytics (Cyence) to leverage the cyber risk knowledge and insights the solution provides to help the company prospect, underwrite, and price risks. Zurich will roll out Cyence globally with an emphasis on enhanced analytics and intelligence for risk selection. Unprecedented technological advances of the 21st century have shifted the nature of risk across the P&C insurance industry. Ever-evolving cyber risks present unique challenges including limited availability of traditional actuarial data needed to model these risks. Cyence combines economic modeling, cybersecurity, machine learning and Internet scale data collection to help risk takers assess the financial impact of cyber risk. “After conducting a thorough search, we found that the capabilities of Guidewire Cyence Risk
Scientist.com Named One of America’s Ten Fastest-Growing Private Companies by Inc. Magazine16.8.2018 15:06 | Tiedote
Scientist.com, the world’s leading marketplace for outsourced scientific services, today announced that it ranked no. 9 on Inc. magazine’s 2018 list of the 5,000 fastest-growing, privately owned companies in America. Scientist.com ranked no. 2 nationally in the Health category and no. 2 in the state of California. The San Diego-based company builds private marketplaces that connect life science research organizations with a global network of over 2,600 contract research organizations (CROs) and providers of scientific services. “Our mission is to empower and connect scientists worldwide and make it possible to cure all human diseases by 2050,” stated Kevin Lustig, Scientist.com’s CEO and Founder. “On Scientist.com, a single, highly trained scientist can run an entire drug discovery program from concept to clinic from his or her laptop without ever physically entering a laboratory.” The pharmaceutical industry spends about $150B a year on medical research and produces about 25 new medic
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme