Traumatic brain injury (TBI) is a brief episode of neurological dysfunction that can increase the likelihood of stroke or epilepsy. TBI is complex, presenting with a broad spectrum of symptoms that can result in permanent disabilities. Approximately 1.4 million people in the United States sustain a TBI each year, resulting in more than 235,000 hospitalizations and 50,000 deaths. An estimated 5.3 million Americans have current long-term disabilities as a result of TBI including post-traumatic epilepsy.(http://www.cdc.gov/ncipc/tbi/tbi.htm). Sports and recreational activities contribute to about 21% of all TBI among American children and adolescents. In 2005 alone, nearly 37,000 of 64,500 bicycle-related head injuries treated in US hospital emergency rooms were in children ages 14 years and younger. Most people at risk for mild TBI are young, and prolonged cognitive deficit from concussions are profound. Mild TBI is the most prevalent form of injury in military settings. The annual cost to society of TBI is estimated at $60 billion, which does not include those injured in combat, the numbers of which are increasing. TBI victims typically suffer in both short- and long-term sequelae, leading to acute or chronic neurological deficits. TBI is associated with a broad range of physical, cognitive, emotional, and social problems in individuals.
In the U.S. at least 1% by the age of 20 and 3% by the age of 70 suffer unprovoked convulsions of unknown origin. Stroke and traumatic brain injury increase seizure likelihood by 50% within the next two years after the incident leading to epilepsy. About 2.5 million Americans have epilepsy; of the 180,000 cases that develop each year, up to 50% are in children and adolescents. To date, an unmet diagnostic need exists for a blood test that can assess brain-related seizures or epilepsy, TBI and prenatal/natal brain pathology.
Mild TBI has both short- and long-term impact on brain function, leading to acute or chronic neurological deficits. Depending on the location of the injury, mild TBI can also cause epilepsy and increases the risk for other neurological disorders. Timely and accurate diagnosis of concussion is critical as the vast majority of irreversible brain damage is complete within 4 to 6 hours of TBI. A late diagnosis and treatment can increase the likelihood of neurological diseases like stroke and epilepsy. However, with early detection and improved treatment TBI patient might recover completely.
Diagnosis of mild TBI can be difficult. Progression of brain injury can only partially be predicted based on routinely available clinical, laboratory, and imaging (MRI, MRA, and CT scans) data. Timely recognition and prediction of mTBI sequelae, as well as selecting the right treatment strategy, is critical.
Current unmet medical needs include recognition of short- and long-term consequences of head trauma (especially in emergency setting). To date, no commercially available simple blood test that can assess the consequences of mTBI and likelihood of post concussion syndrome or other severe complications including post-traumatic epilepsy. The ideal blood test should reliably detect or exclude mild TBI, predict consequences such as cerebrovascular abnormalities (for example, TIA/stroke or post-traumatic seizures) and help with prognosis of recovery and outcome.
GRACE Laboratories has developed proprietary biomarkers and cost-effective test kits that shorten the time required by a physician to diagnose mTBI and its consequences and initiate appropriate treatment. Utilizing just a few microliters of a patient’s serum or plasma, the test kits: In conjunction with clinical assessment and brain imaging, these biomarkers may provide greater diagnostic certainty in the evaluation of patients after concussion.