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Development

TBI Panels

Traumatic Brain Injury (TBI) Panels

Program in Traumatic Brain Injury (TBI)

ImmunArray, in collaboration with John Hopkins School of Medicine, researchers from Cedars-Sinai Medical Center, and led by a Scientific Advisory Board of internationally recognized clinicians in the field, is developing a series of assays and multiplex tests to assist in the diagnosis and prognosis of Traumatic Brain Injury (TBI), in both acute and chronic phases.

The Company is developing a family of products to assess a patient’s response to an acute physical traumatic event at the time of injury and throughout the recovery period. This product family is envisioned to contain (i) a series of protein-based multi-analyte (3-5 biomarker) panel tests for use at initial evaluation, and ii) to follow a patient with persistent symptoms over time. As there currently are no blood tests or widely acknowledged markers developed to diagnose and monitor the treatment of TBI, we intend to represent a key clinical solution, by providing tools for rule in and rule out of TBI, including the accurate diagnosis of a concussion, and during the long term follow up and testing period to determine the most appropriate time for returning to work or to the playing field.

In January 2014, ImmunArray was selected from over 400 applicants as one of 16 grant recipients in the first phase of the GE-NFL Head Health Challenge. ImmunArray researchers seek to confirm the possible connection between a certain pattern of antibodies associated with acute brain injury and ongoing immunological response to injury.

Intellectual Property in TBI

In addition to determining the long-term effects of these acute injury biomarkers, the Company’s research, based on its portfolio of licenses from Johns Hopkins University, may aid in the development of a simple, convenient, point-of-care blood test, that can provide diagnostic results quickly and with certainty to those treating trauma victims, athletes or military personnel who have suffered from brain injury. For this purpose ImmunArray has in-licensed a family of more than twenty (20) biomarkers from Johns Hopkins University (JHU), and has continued to expand on this portfolio.

Proving the Utility of Biomarker Panels in Large Clinical Study Cohorts

ImmunArray is in the process of developing commercial grade assays to assess the portfolio of markers in a Company-sponsored 500 patient prospective clinical study, HeadSMART, being conducted at two JHU campuses (the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center). The study protocol specifies blood sample collection at multiple time points (presentation, four hours, 24-hours, seven days, thirty days, etc.), imaging (CT and in specific circumstances MRI) and behavioral observation and assessment (e.g., neuropsychiatric batteries, Rivermead Behavioral Memory Test, Glasgow Outcome Scale Extended, GOSE).

The results from this study will be used to continue the development of panels of biomarkers across the continuum of care following TBI, during which different biological processes are taking place as the brain is reorganized and repaired. The findings of these studies are critical to providing improved diagnostic characterization of TBI patients across the recovery period. Results from the HeadSMART study are being validated in several additional clinical TBI cohorts and healthy individuals to ensure their clinical utility.