UCHL1

Research by Orlando Health physician pioneered development of new TBI blood test ORLANDO, Fla., Aug. 13, 2024 /PRNewswire/ -- Today, Orlando Health Orlando Regional Medical Center (ORMC) is the first hospital in the world to use a new, groundbreaking blood test to help assess patients with suspected mild traumatic brain injuries (TBIs), or concussions. The rapid TBI blood test provides results in just 15 minutes and was developed by Abbott, in collaboration with the Department of Defense, and built upon innovative research that Orlando Health's Dr. Linda Papa and others helped pioneer over 20 years ago. Continue Reading Dr. Linda Papa, Orlando Health According to the National Institutes of Health, traumatic brain injury from accidents or sports is a leading cause of death and disability in the United States. And the CDC estimates that 2.5 million people visited the emergency department for TBIs in one year. Nearly 25 years ago, Dr. Papa noticed as an emergency medicine physician that doctors had blood tests to help diagnose and treat conditions for many major organs like the heart, liver and kidneys. But there was no blood test for the brain. She was inspired by her patients to find a way to blunt the impacts of TBIs through science, and her research and body of work reflect her dedication to helping patients with TBIs. This is why it is particularly noteworthy that Orlando Health, led by Dr. Papa, will be the first hospital system in the world to roll out Abbott's i-STAT TBI blood test. With this new test at their fingertips, Orlando Health emergency room physicians can now more quickly assess patients during those critical moments when every second counts. "Now, doctors are finally armed with a blood test to check your brain," said Dr. Linda Papa, Director of Clinical Research at Orlando Health. "This is a game-changer, and we are just getting started." New TBI blood test provides rapid results Abbott's i-STAT TBI test provides results in just 15 minutes by checking a patient's blood for two biomarkers that may be present after suffering a brain injury. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care. Dr. Papa was a pioneer in identifying the biomarkers used in the TBI blood test and her over two decades of innovative research played a pivotal role in test development. "During a head trauma, a person's brain gets jostled. Damaged brain cells release two proteins: GFAP and UCH-L1 into their blood," said Dr. Papa. "The higher the concentrations of these proteins, the more severe the brain injury. The quicker doctors can detect these brain injuries, the quicker a patient can get life-saving treatment. On the flip side, if we find these biomarkers are not elevated in their blood within 24 hours of trauma, that may indicate that they do not need to have a CT scan." The new TBI blood test is now an innovative tool in a doctor's toolbox. Currently, CT scans are the most common way to diagnose brain lesions. However, they are time-consuming, expensive and associated with radiation exposure. The TBI blood test could cut down on the need for CT scans. For decades, concussion evaluation has been the same — utilizing a physical examination of a patient to subjectively assess a concussion and imaging to detect brain tissue damage or lesions. "TBI patients can sometimes be challenging to assess in an emergency department," said Chris Davlantes, M.D., senior director of Global Medical & Scientific Affairs in Abbott's Point of Care Diagnostics division and practicing ER physician. "During critical moments of uncertainty, a blood test can add objective information to quickly assess which patients can be safely sent home without imaging. We're thrilled to collaborate with Orlando Health, a pioneer in concussion management, to introduce this important test for traumatic brain injuries—marking a significant advancement in the standard of care for patients." Orlando Health Leads the Way Each month, Orlando Health ORMC's emergency department sees an average of 125 patients who have sustained a traumatic brain injury. Orlando Health ORMC is proud to be home to Central Florida's only Level One Trauma Center. "We are incredibly proud to be the first hospital in the world to roll out this new blood test for traumatic brain injuries," said Kelly Nierstedt, Senior Vice President of Orlando Health and President of Orlando Health Orlando Regional Medical Center. "Dr. Papa is a visionary. Her decades of trailblazing TBI research highlight Orlando Health's commitment to patient care and strategic innovation. We are honored to be on the leading edge of healthcare throughout the entire journey from the research lab to the patient's bedside." Now, Dr. Papa is working on evaluating the test in children. She also continues to be actively involved in Orlando Health's clinical implementation of Abbott's blood test to help adult patients with suspected TBIs. "It was a humble beginning. I started this research by going around the emergency department asking patients to participate in our study and collecting blood samples to test for brain injury biomarkers," said Dr. Papa, "We owe a debt of gratitude to all the patients and families who agreed to participate in this research because they helped make this test possible." Dr. Papa has evaluated different aspects of the blood test through various studies and has been the lead author of many studies published in journals such as JAMA Neurology, JAMA Network Open, Nature Scientific Reports, Journal of Neurotrauma, BMJ Paediatrics Open, Academic Emergency Medicine, Annals of Emergency Medicine and Journal of Trauma. Handout video: Broll Soundbites About Abbott's i-STAT TBI Test Abbott's i-STAT TBI cartridge received clearance from the U.S. Food and Drug Administration (FDA) to be used with venous whole blood in early 2024. This test can be used to help evaluate patients 18 years and older, up to 24 hours after injury. The i-STAT TBI cartridge is the latest addition to Abbott's TBI test portfolio, which also includes the i-STAT TBI Plasma cartridge and the ARCHITECT® and Alinity i lab test (serum and plasma). The ability to use whole blood to help assess TBI is an important step in Abbott's vision to make its tests available in all settings where people seek care for head injuries including outside traditional healthcare settings, such as at athletic facilities. Abbott is engaged in ongoing research and planning that may, in the future, allow the test to be used with a broader population including teens and pediatrics. The test is currently being evaluated for use in the pediatric population age 17 and under. The i-STAT TBI test was developed in collaboration with the U.S. Department of Defense U.S. Army Medical Research and Development Command's (USAMRDC) and U.S. Army Medical Materiel Development Activity (USAMMDA). The USAMRDC has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than two decades and has played a critical role in developing the TBI test on Abbott's i-STAT Alinity system. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care. All clinical trials for the test were run through the TRACK consortium. About Orlando Health Orlando Health is a private not-for-profit, integrated academic healthcare system with $10.5 billion of assets under management, that serves the southeastern United States and Puerto Rico. With corporate offices in Orlando, Florida the system provides a complete continuum of care across a network of medical centers and institutes, community and specialty hospitals, physician practices, urgent care facilities, skilled nursing facilities, home healthcare, and long-term and behavioral health care services. Founded more than 100 years ago, Orlando Health's mission is to improve the health and the quality of life of the individuals and communities we serve. The system provided nearly $1.3 billion in community impact in the form of community benefit programs and services, Medicare shortfalls, bad debt, community-building activities and capital investments in FY 22, the most recent period for which the information is available. For more information, visit orlandohealth.com, or follow us on LinkedIn, Facebook, Instagram and X (formerly Twitter.)Media Contact: Marlei Martinez [email protected] (407) 308-2243 cell SOURCE Orlando Health, Inc.

The biomarkers chosen by Labcorp and Quest Diagnostics have also recently been advanced by other developers. The twin clinical testing giants Labcorp and Quest Diagnostics have each, in the past week, added to their portfolios new blood tests that aim to peek into the workings of the human brain.  First, Labcorp announced the availability of a commercial test for glial fibrillary acidic protein, a biomarker released into the bloodstream by certain cells within the brain following neurological damage. The company said the GFAP immunoassay could help track the early progression of diseases such as Alzheimer's, multiple sclerosis or glioblastoma as well as help identify traumatic brain injuries. Labcorp’s blood-based neurology catalog also includes biomarker tests for the Alzheimer’s hallmark proteins of beta amyloid and tau as well as for neurofilament light chain, which has been linked to dementia, Huntington’s disease and amyotrophic lateral sclerosis, better known as ALS. Meanwhile, Quest will begin offering a blood screener for a specific type of Alzheimer’s protein—phosphorylated tau 217, or pTau-217—within its AD-Detect product line, which was launched last year targeting general consumers amid some criticism over its accuracy and need for follow-ups. The pTau-217 test will join Quest assays for pTau-181 and beta amyloid, in addition to the Alzheimer’s risk factor apolipoprotein E, to help evaluate patients displaying cognitive impairment. “Testing to assess Alzheimer's disease has changed rapidly in the last few years, and we expect this area to continue evolving,” Quest’s medical director for neurology, Michael Racke, M.D., said in a statement.  “The future of assessing risk or diagnosing AD will likely include a variety of testing modalities and biomarkers, including blood, to help clinicians identify patients in the early stages of disease progression,” Racke said. “When examined with cognitive test results, p-tau217 has the potential to aid diagnosis, and will play a valuable role in assessing patients with cognitive impairment, especially when combined with other tests.” The biomarkers chosen by Labcorp and Quest have also recently been advanced by other developers.  Earlier this month, Abbott received an expanded FDA clearance for the use of the GFAP protein within its hand-held, cartridge-based whole blood test for detecting concussions or mild traumatic brain injuries.  The company’s i-STAT Alinity diagnostic device—which also relies on the brain damage biomarker ubiquitin C-terminal hydrolase L1—has its sights set on one day providing quick analyses on the sidelines of sporting events, but currently its FDA green light only extends as far as locations with certified laboratory testing privileges. Previous clinical data showed that checking that pair of biomarkers could also help predict how well a patient will recover from a TBI in the weeks that follow, as well as their chances of long-term complications such as comas, disability or death. At the same time, pTau-217 recently collected an FDA breakthrough designation as part of an Alzheimer’s blood test being developed by Roche and Eli Lilly. Roche’s Elecsys plasma assay quantifies the protein, with positive results correlating with high chances that a patient may display amyloid plaques on a PET scan. Last month also saw the FDA publish a new draft guidance on how the agency may review Alzheimer’s therapy hopefuls saying measures showing amyloid reduction could serve as a surrogate in clinical trials but did not go as far as to say that it could serve as a study’s primary endpoint alone. With Roche’s help, Eli Lilly said it believes pTau-217 could potentially help identify patients eligible for clinical trials in Alzheimer’s or point them to approved therapies.

Abbott said its 15-minute, hand-held blood test could help rule out the need for imaging scans to check for tissue damage in the 24 hours following a possible concussion or traumatic brain injury. Abbott has obtained a new clearance from the FDA for its rapid blood test to check out patients suspected of having a concussion or a mild traumatic brain injury. With a 15-minute result given by a hand-held cartridge reader, the company said its test can be used at an adult’s bedside in an emergency room as well as within urgent care clinics or other healthcare settings to help rule out the need for a CT scan. It is designed to be used within the first 24 hours after a head injury. But you won’t see Abbott’s i-STAT Alinity diagnostic device on the sidelines of sporting events just yet—the FDA’s green light still limits its use to locations with certified laboratory testing privileges. The latest clearance, however, is a step in that direction, as it now allows the hand-held test to use whole, untreated blood samples. Its first FDA nod, from early 2021, had required that blood samples first be spun in a lab centrifuge to separate out the necessary plasma. The test also picked up a separate green light last year for its use on Abbott’s larger Alinity lab hardware. “Clinicians have needed an objective way to assess patients with concussions,” Beth McQuiston, M.D., medical director in Abbott's diagnostics business, said in a statement. The company estimates that nearly 5 million people in the U.S. visit emergency rooms for a TBI each year, while more than half of people who may have a concussion never get checked. “When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening,” McQuiston said. “Now, we have a whole blood test that can help assess the brain right at the patient's bedside—expanding access to more health providers and therefore patients.” The cartridge-based test searches the blood for two compounds released by the brain following tissue damage, known as ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein.  A previous clinical study showed that an early analysis of these biomarkers could also help predict how well a patient will recover from a TBI in the weeks that follow as well as the chances of long-term complications such as comas, disability or death. Abbott said it is currently developing its i-STAT test into one that can be used nearly anywhere as well as with teenagers and children.