Blood test detects concussion related brain damage

Blood Test for Concussion OK'd

The FDA approved the first blood test to help diagnose traumatic brain injuries on February 14, according to a recent report by AP News.

Scott Gottlieb, M.D., Commissioner of the US Food and Drug Administration said in a statement during the Wednesday's news release that, "Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority". The test can be used to reduce radiation exposure to patients. The company developed the test with partial support from a contract with the U.S. Army. The Brain Trauma Indicator could could also be used at sports games and in the military, the agency said. The Brain Trauma Indicator could foresee the nearness of intracranial sores on a CT filter 97.5 percent of the time and the individuals who did not have intracranial sores on a CT examine 99.6 percent of the time.

The test was approved as part of the FDA's Breakthrough Devices Program, which is a voluntary program for some medical devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications".

The FDA approved the blood tests that can detect signs of brain injury. The goal of the study was to identify patients with head trauma who could safely forego the need for a CT scan thereby avoiding unnecessary radiation to the brain and reduce costs of care. Most people who present with concussion symptoms, like impaired memory, problems with movements or sensations, or compromised emotional function, turn out to have negative CT scans, the FDA said.

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The blood test from Banyan Biomarkers Inc. could be useful in diagnosing brain injuries that lead to an estimated 2.5 million emergency-room visits each year.

The findings indicate that the test can reliably predict the absence of intracranial lesions. Test outcomes can be accessible inside 3 to 4 hours. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won't.

The maker of the blood test, Florida company Banyan Biomarkers, reported in 2015 results of a comparative trial in 1947 cases. The organization likewise is in charge of the wellbeing and security of our country's nourishment supply, beauty care products, dietary supplements, items that emit electronic radiation, and for controlling tobacco items.

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