Blood test detects concussions without X-rays

Blood Test for Concussion OK'd

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.

Because Banyan BTI is the first blood test for brain injury that the FDA has approved for sale, its approval creates a new classification for these types of diagnostics. And it's just the latest example of technology striving to revolutionize how we diagnose diseases and injuries by making tests less invasive (and health care less costly). A sizeable number do not, as the FDA points out. The company is also studying how its tests could be used to assess other brain conditions.

"A blood test that accurately, reliably and consistently detects the presence of brain proteins that appear in the blood after a brain injury is a major advance", said Dr David Dodick, a fellow of the American Academy of Neurology, who was not involved in the development of the test. The test, called the Brain Trauma Indicator, was approved in fewer than 6 months as part of the FDA's breakthrough devices program.

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The usual detection method for concussions will remain CT scans outside Emergency Rooms of the U.S. hospitals but the newly FDA-approved blood tests to diagnose brain injury are believed to gain more popularity later this year.

"A blood-testing option for the evaluation of mild TBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases", said FDA Commissioner Dr. Scott Gottlieb. The company developed the test with partial support from a contract with the U.S. Army. When the test results come out in four hours, they can then help doctors decide if a CT scan is needed. These discoveries show that the test can dependably foresee the nonappearance of intracranial sores and that medicinal services experts can consolidate this device into the standard of watch over patients to preclude the requirement for a CT examine in no less than 33% of patients who are associated with having mTBI. Abbott has licensed both protein biomarkers from Banyan and is developing its own blood tests.

The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product's performance by comparing mTBI/concussion blood tests results with CT scan results.

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"That's what we'd like to have for the brain", he said.

A study of almost 2,000 individual blood samples saw the Brain Trauma Indicator accurately predict the presence of intracranial lesions on CT scan 97.5 percent of the time, while correctly predicting the absence of said lesions 99.6 percent of the time.

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