Molecular diagnostic company’s research into blood-based diagnosis of traumatic brain injury presented at national conferences
Richmond, Va., July 18, 2016 – Clinical research into ways in which blood-based biomarkers can provide precise and timely diagnosis of traumatic brain injury (TBI) is leading to encouraging results, with some studies resulting in a diagnosis with more than 95 percent sensitivity and specificity.
The research conducted by ImmunArray, a molecular diagnostic company whose SLE-key® Rule-Out test has already led to unprecedented levels of accuracy in ruling out a diagnosis of lupus (Systemic Lupus Erythematosus), has been presented to date at four national TBI-related conferences this year: The Keystone Neurotrauma in January; Arrowhead TBI in May; National Neurotrauma Society’s Neurotrauma 2016 in June; and the American Academy of Neurology: Concussion meeting in July. A fifth presentation will be made next month at the 2016 Military Health System Research Symposium.
HeadSMART, a continuing company sponsored prospective traumatic brain injury study, enrolled its 500th patient in June. This investigation follows patients at multiple time points for 6 months after injury, reviewing clinical symptoms, evaluating imaging results and performing a complete psychological profile. Additional analyses continue, with more presentations and publications to come.
An interim HeadSMART analysis of 241 TBI patients, versus 250 healthy controls, found that while no single marker had a clinically relevant levels of sensitivity and specificity, unique panels had sensitivity and specificity exceeding 95 percent.
“These results are tremendously encouraging,” said Donna Edmonds, chairman and CEO of ImmunArray. Edmonds is applying decades of experience in Cardiovascular Biomarker development and successful commercialization to the company and TBI. “The ability to determine if you need to perform imaging or actually have an injury in the face of a negative CT scan, as is the case in up to more than 25-30 percent of the time, based on the study and patients cited. This promises to be a an important medical advance in the diagnosis and treatment of TBI. To do it in a timely, accurate and affordable way, through a simple blood test, is a significant contribution to clinical care.”
“Traumatic Brain Injury (TBI) is a biologically complex disease without a test, said Frank Peacock, M.D., professor, Emergency Medicine, Associate Chair and Research Director, Baylor College of Medicine. “This creates enormous problems in identifying who has the disease, and for determining what can be done to prevent or treat its occurrence. A blood test to define which patients have suffered TBI would have a remarkable impact on the future of those who may potentially have suffered a TBI. ImmunArray’s very encouraging results to date may represent a useful clinical tool.”
Approximately 5 million people annually go to hospital emergency rooms with suspected brain injuries. While CT scan technology is widely available to test patients for the possibility of a concussion, a more sophisticated and reliable diagnostic tool is needed to more accurately determine whether or not a patient sustained a TBI. Currently, 90 percent of CT scans return negative results.
In 2014 ImmunArray received a $300,000 grant from the GE/National Football League Head Health Challenge for research into the possible connection between certain patterns of antibodies associated with acute brain injury and ongoing immunological response to injury.
Co-located in Rehovot, Israel and Richmond, Va., ImmunArray is a privately funded molecular diagnostics company dedicated to the development of novel blood-based tests that support the diagnosis and management of complex acute and chronic immune and neurodegenerative diseases. The company designs and analyzes sets of biomarkers known to be linked to a particular condition and develops tests on platforms that are most appropriate to facilitate the adoption of additional tests. The company, which has introduced its first commercial tests, is currently conducting research in collaboration with leading clinicians and medical centers in the U.S. and Israel. The company was a grant recipient of the GE-NFL Head Health Challenge as well as secured additional corporate research funding to conduct research into the use of biomarkers to identify traumatic brain injury. For more information about ImmunArray, visit www.immunarray.com.