Traumatic Brain Injury (TBI)
Traumatic Brain Injury – Overview and Diagnosis
TBI is an injury to the head from a bump, blow, or jolt or a penetrating head injury that disrupts the normal function of the brain. TBI is considered to be a silent epidemic in the U.S. Based on 2009 and 2010 National Hospital Ambulatory Medical Care Surveys (NHAMCS) data, an estimated 4.8 million patients are evaluated each year for TBI in U.S. hospital emergency departments and an estimated 2.5 million patients (52%) are diagnosed with TBI (Korley et al., Journal of Head Trauma Rehabilitation, September 2015). Acute TBI, including concussions, can be silent and occur without any loss of consciousness. TBI is the leading cause of death and disability in people under 45 years old, occurring more frequently than breast cancer, AIDS, multiple sclerosis and spinal cord injury, combined.
The long-term effects of TBI vary enormously from person to person. They consist of physical disabilities, cognitive effects, and emotional problems. Symptoms that persist in brain-injured patients can have debilitating effects on job performance, social engagements and personal relationships, and persist for many months following injury.
Acute Tests – Product Overview
ImmunArray is developing a series of blood-based protein tests or panel tests (the “panels”) to be administered in particular to mild TBI (mTBI) patients following an acute injury as part of the initial diagnosis at the time of presentation. Today, mild TBI patients typically present at the hospital emergency department. ImmunArray is developing panel tests to be run in the emergency department, in the hospital central laboratory or a clinic where a post injured patient would present for follow up care. ImmunArray is exploring strategic partnerships with a number of companies around point of care and laboratory testing, as well as over the full continuum of care.
ImmunArray’s panel tests aim to address the acute TBI market by providing physicians with additional information based on blood biomarkers that may more clearly identify those patients that have TBI, or that may be at risk of complications from the acute event. This information may be used in conjunction with imaging to develop a specific treatment plan based on the patient’s response to the acute event.
Long-term Monitoring or Chronic Test – Product Overview
ImmunArray is developing a monitoring test using the Company’s iCHIP® technology to help doctors predict short and long-term complications of TBI, assisting doctors in prognosis and treatment. The test will monitor an array of antigens to track chronic conditions resulting from acute injury and to assist in determining when patients can safely return to work or play.
Physicians currently have no definitive way to predict whether a patient will develop long-term complications to TBI and there is no diagnostic test that (i) predicts whether a TBI patient will develop long-term consequences or (ii) monitors chronic conditions associated with TBI. Approximately 15% of patients with mTBI suffer from chronic neurological problems, but physicians lack an objective method of predicting long-term effects of the injury.
ImmunArray’s autoantibody-based chronic test directly addresses the market need of predicting short and long-term complications of TBI and monitoring these patients throughout their recovery.