Op-ed views and opinions expressed are solely those of the author.
Millions of Americans suffer concussions every single year, which can be life-altering. But up to now, there is no cure for the often serious brain injury. For the first time in history, medical science is on track to not only diagnose but also treat concussions, with the combination of an FDA-approved test, new research that reveals its effectiveness, and a new treatment that is currently in human trials.
A new study published in The Lancet Neurology revealed that doctors can now identify biomarkers that predict how someone will recover from a traumatic brain injury. By tracking those biomarkers in the immediate aftermath of any head trauma, doctors will be able to tell if someone has suffered a concussion or something more serious.
The researchers made use of the FDA-approved i-STAT™ TBI Plasma test from Abbott Laboratories (NYSE: ABT), a global healthcare company that has a portfolio of technologies spanning the spectrum of healthcare, with businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. The markers were measured using the company’s ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery.
Researchers measured levels of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin carboxy-terminal Hydrolase L1 (UCH-L1) present in blood plasma within 24 hours of injury. After testing biomarker levels on the day of injury, researchers evaluated patients six months later, tracking how individuals fared and how biomarker levels corresponded to their recovery.
“Brain injury biomarkers will one day be the standard of care to evaluate and treat patients,” said Dr. Fred Korley, an associate professor of emergency medicine at the University of Michigan and the first author of the study in a press release from Abbott. “Objective biomarker data can be profoundly helpful in determining prognosis for a patient, helping to gauge how severe a brain injury is, and can ultimately inform how best to counsel family members about care for their loved ones with brain injury.”
Abbott is pursuing FDA clearance under Breakthrough Designation for the TBI test on its Alinity i and ARCHITECT core laboratory instruments, which will broaden access and ensure that tests are available both in the lab and in other settings where people need immediate answers and care. Abbott’s TBI test on Alinity i is CE Marked and available outside the U.S.
Abbott’s TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD) – which has been dedicated to creating a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through the U.S. Army Medical Research and Development Command‘s (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing the test run on Abbott’s i-STAT TBI platform.
This test and research bookends well with the potentially first-ever concussion treatment currently in human trials. Odyssey Health, Inc. (OTC: ODYY), a company focused on developing unique, life-enhancing medical products, recently announced the successful completion of safety measures for their Phase I Multi-Day Ascending Dosing (MAD) clinical trial for a new potential concussion treatment. Odyssey’s trial involves administering the company’s novel drug to treat concussions, PRV-002, to healthy human subjects. For MAD Cohort I, the drug was safe and well tolerated.
The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecasted to reach $8.9 billion by 2027, according to Grandview Research. Common settings for suffering concussion include contact sports, military training and operations, motor vehicle accidents, children at play, and falls in elderly assisted-living facilities.
“After reviewing the data from MAD Cohort I, I have strong confidence that PRV-002 will continue to show safety during the final, high-dose MAD portion of the Phase I clinical trial. We have unanimously approved the start of MAD Cohort II. The overall low levels of PRV-002 in the blood support the hypothesis that more of the drug is getting to the brain itself when administered with the intranasal device. If this turns out to be the case, not only can the targeted effects of the drug be more efficacious, but the drug will also likely have fewer potential side effects,” commented Dallas Hack, MD, member of the Safety Review Committee, in an Odyssey press release.
Odyssey Health has been built at the intersection of vast unmet medical needs and multiple market opportunities. The company’s development of novel drug compounds that could provide treatment for the damage from concussions could ultimately create the first FDA-approved treatment for concussions. In the U.S., there are more than five million concussions reported each year, with more than 69 million worldwide, representing a potential $400 billion market opportunity.
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