Dr. Beth McQuiston Shares her Views on the US FDA Clearance of the First Concussion Blood Test Available for Lab Instruments
- Dr. Beth discussed traumatic brain injuries (TBIs) and the new TBI blood test by Abbott. She told PharmaShots how this blood test measures specific biomarkers, offering objective results within 12 hours, and aiding in evaluating suspected mild TBIs
- She also talked about how Abbott’s Alinity i lab technology facilitates swift testing, complementing Abbott's i-STAT TBI Plasma test which is available outside the US. The test aims to broaden access and awareness among healthcare providers.
- The interview gives an understanding of how Abbott innovates its healthcare portfolio: diagnostics, devices, nutrition, generics, transforming lives comprehensively
Smriti: Thanks for taking out time to talk to us, firstly we would like to talk about what TBI or Traumatic Brain Injury is (its Epidem, causes, classification, etc.)
Dr. Beth McQuiston: A traumatic brain injury (TBI) – which includes concussions – is caused by a hit, blow or jolt to the head or body that causes the brain to suddenly move inside the skull, causing damage to the brain. A concussion is referred clinically as a “mild” TBI (even though there is nothing mild about any form of brain injury).
A lot of people think you have to sustain serious external damage to your head to have a brain injury – but in reality, even whiplash from a car crash or blast can cause significant harm to your brain. Your brain is essentially a superhighway of neurons and when any of those roads are blocked, or damaged, it can affect the way you act, think or feel.
TBIs can impact your health both in the short- and long-term. People who experience a TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). Effects of TBI can be immediate and last anywhere from a few hours or days to much longer. People who sustain a TBI are more likely to have another one – similar to how a sprained ankle or torn ligament is more susceptible to future injury.
Smriti: What are the unmet needs of TBI patients in terms of diagnostics and how are these being solved by the TBI blood test of Abbott?
Dr. Beth McQuiston: Millions of people sustain concussions or TBIs every year, but we know that over 1 in 2 people who suspect they have a concussion never get it checked. There are many reasons for that, but one of them is that people are skeptical that they’ll get any definitive answers.
This is because concussion and TBI evaluation have remained the same for decades – ever since the Glasgow Coma Scale was introduced in the 1970s. If you come into the ER for a possible concussion, doctors will ask you a series of questions, do a brief physical exam and determine whether to send you for a CT scan, which checks for brain bleeds. Often, they will, to be safe.
Our test introduces game-changing objective information via a blood test that measures brain-injury-specific biomarkers in the bloodstream down to the picogram level. In about 4 out of 10 people, we’re giving them peace of mind that they are negative for a possible concussion or TBI and they can go home with peace of mind – saving them time, and also money, because our test rules out the need for a CT scan. For people who test positive, doctors can use that information for further evaluation.
As hospitals across the country begin to adopt this blood test for the brain, we hope the knowledge that people can receive an objective number to help inform the evaluation of concussion will entice them to get their heads checked. Walking it off, or toughing it out, is never the right answer. And you can’t treat what you don’t know.
Smriti: Please shed some light on the data following the U.S. FDA clearance of the Traumatic Brain Injury (TBI) blood test. Also, discuss the study and its results that have been used to gain this clearance.
Dr. Beth McQuiston: The Alinity i TBI test measures complementary biomarkers in blood plasma and serum - Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 96.7% sensitivity and 99.4% negative predictive value.
Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers decide appropriate next steps and develop a plan to care for patients. The test is for use to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.
Smriti: How can the TBI blood test prove to be a more economical and time-saving option for patients?
Dr. Beth McQuiston: For decades, standard concussion assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions. Having a blood test available could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing costs to the healthcare system and the patient as well as the amount of time they spend in the emergency department.
Smriti: As the TBI blood test is the first commercially available test for brain injuries, how does Abbott plan to bring the test to the notice of HCPs and patients (HCP engagement and education programs)?
Dr. Beth McQuiston: Hospitals across the country already use our Alinity i lab technology, so the TBI test can be used seamlessly within an existing setup. We will be communicating with health care providers, lab specialists and hospital leaders on the benefits of the test for doctors and patients and how they can begin to implement it.
Smriti: Apart from the U.S., in which geographical locations are you planning to commercialize the TBI blood test?
Dr. Beth McQuiston: The test has been available in markets outside of the U.S., including many in Europe, for about two years.
Smriti: Elaborate about Abbott’s Alinity i laboratory instrument. Has Abbott developed / is developing another test using the technology?
Dr. Beth McQuiston: The new test will run on Abbott’s Alinity® i laboratory instrument, which can run hundreds of tests simultaneously with results in 18 minutes, including TBI and other markers for things like cancer, cardiac, pregnancy, hepatitis, metabolic, thyroid and more. It complements Abbott’s rapid, portable i-STAT TBI Plasma test, cleared by the FDA in 2021, which produces a result in just 15 minutes.
Given the significant number of Alinity i instruments in use in labs across the U.S., Abbott’s lab test will make concussion testing available to more people across the country.
Broadening the availability of the TBI blood test for use on lab-based instruments is an important step in Abbott's strategy to ensure its tests are available in all settings where people seek care for head injuries.
About the Author:
Dr. Beth McQuiston
Dr. Beth McQuiston is a board-certified neurologist, registered dietitian, and medical director for Abbott’s diagnostics business. Her current areas of focus include research into biomarkers for use in traumatic brain injury, including concussions. She obtained her medical doctorate degree at Rush University and completed her medical training at the University of Chicago, Rush University Medical Center and Harbor UCLA Medical Center. Dr. McQuiston is a member of the TBI Endpoints Development (TED) Initiative and has served on the executive committee of the Center for Nutrition Learning and Memory for several years.
Senior Editor at PharmaShots. She is curious and very passionate about recent updates and developments in the life sciences industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.