Abbott to launch 1,000+ patient trial to standardize traumatic brain injury testing

Abbott's i-Stat System--Courtesy of Abbott Laboratories

Abbott ($ABT) will launch a major study of several brain injury evaluation approaches along with researchers at Hennepin County Medical Center in Minneapolis, MN, and the University of Minnesota. The goal is to evaluate a number of different tools including eye tracking, blood-based biomarkers, imaging and cognitive measures to develop a standard protocol for identifying brain injuries--including concussions.

There are rapid research advances occurring on each of those fronts that were reviewed at an FDA meeting earlier this month that was dedicated entirely to the subject of traumatic brain injury diagnostics.

Abbott is developing a blood-based biomarker test to run on its handheld, portable i-STAT device that's expected to be used at the point of care. Part of this study will be devoted to evaluating various blood-based biomarkers that could indicate brain injury.

"When someone experiences a head injury like a concussion, specific protein biomarkers will be found in the blood," said Dr. Beth McQuiston, medical director of diagnostics at Abbott, said in a statement. "If the protein levels are higher than normal, that may show a brain injury has occurred and serve as a warning bell that further evaluation is needed."

Neurosurgeon Dr. Uzma Samadani, who is the Rockswold Kaplan Endowed Chair for TBI Research at Hennepin County Medical Center, an associate professor at the University of Minnesota and one of the lead investigators of the study, has dedicated his work to eye-tracking technology that may be more useful than the standard-of-care, which is a CT scan.

In her research, patient eyes are tracked using a high-frequency camera to map the positions of the pupils as they watch television.

"We know that there are different types of brain damage that can occur after trauma, whether it's a mild concussion or a severe injury," said Samadani. "Our goal with this study is to combine multiple assessment techniques to quickly assess the severity of brain injuries and enable clinicians to provide appropriate treatments."

She added, "Data have shown a connection between brain injury and abnormal eye movements. With new high-resolution cameras, we can detect subtle differences in movement much more easily and objectively than in the past."

"Imaging tells us what the brain looks like, eye tracking tells us how well it's working and blood-based biomarkers can tell us the nature of the damage," said Dr. Thomas Bergman, study co-investigator and Chief of Neurosurgery at HCMC. "When we put all of this information together, we will have a better understanding about brain injury that will help us treat patients now and in the future."

The researchers will screen 9,000 trauma patients and enroll at least 1,000 of them in the study. The patients will range from children to the elderly and will be followed for up to one year, which the researchers say will make this study the largest, single-center prospective study of TBI in the U.S.

- here is the announcement

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