Published: Fri, February 16, 2018
Health Care | By Oscar Goodwin

FDA Authorizes Marketing of First Blood Test Aiding in Evaluation of Concussion

FDA Authorizes Marketing of First Blood Test Aiding in Evaluation of Concussion

The Food and Drug Administration has authorized US marketing of the first blood test with the ability to evaluate concussion, or mild traumatic brain injury (mTBI), in adults, the agency announced in a statement Wednesday. The NFL and other professional and amateur sports organizations are attempting to get out in front of the issue by launching new initiatives to detect when a player has suffered a concussion, and then prevent that player from participating until they are cleared. The company's test returns results within four hours. The blood test isn't a substitution for existing diagnostic methods, such as giving the patient a CT scan, but can help determine whether a concussion has happened and whether a CT scan is necessary. Banyan hopes it will eventually make its way to professional sports and the military.

In announcing the approval FDA commissioner Scott Gottlieb said the blood test fitted with his organisation's plan to reduce unnecessary radiation exposure as much as possible.

For more information, see the entire story below.

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The test "sets the stage for a more modernized standard of care for testing of suspected cases", Gottlieb said in a statement.

TBI cases stack up into the millions on an annual basis, the U.S. Centers for Disease Control and Prevention reported in 2013, reaching 2.8 million cases of TBI-related emergency department visits in that year alone. 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.

Hank Nordhiff, chairman and CEO of Banyan Biomarkers, said that the test would cost closer to US$150, compared to the US$800 to US$1,500 fee for a CT scan. Banyan Biomarkers picked up the approval after showing the test reliably rules out intracranial lesions.

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Traditional concussion evaluation includes a CT scan of the head to detect any brain tissue damage. This exposes patients to radiation and drives up healthcare costs. 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.

Quanterix is also working to develop a blood test to diagnose concussions and other brain injuries.

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