Published: Fri, February 16, 2018
Medical | By Josefina Yates

FDA Approves Marketing Of First Blood Test To Diagnose Concussions

FDA Approves Marketing Of First Blood Test To Diagnose Concussions

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. Accessibility of a blood test for blackout will enable wellbeing to mind experts decide the requirement for a CT check in patients associated with having mTBI and help forestall superfluous neuroimaging and related radiation presentation to patients. 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. With that information, the FDA said the test was able to predict the presence of a brain lesion 97.5 percent of the time and correctly determined which patients didn't have a lesion 99.6 percent of the time.

The blood test measures levels of proteins UCH-L1 and GFAP that are released from the brain into blood and measured within 12 hours after the head injury happened. It also shows that absence of the two proteins in the test is a good indication that CT scans will be normal. However, CT scans don't always detect concussion. The FDA thinks the test will enable doctors to spare one-third of patients with suspected head injuries from undergoing CT scans. Levels of these blood proteins after mTBI/blackout can help anticipate which patients may have intracranial injuries obvious by CT output and which won't.

The FDA has approved a blood test for use in the detection of concussion for the first time.

Patients with a positive test would need a CT scan to confirm the results and determine if surgery or other treatment is needed. That limitation in research data dictated the FDA's approval of the blood test's marketing to adults.

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That prize would be a test that could detect and guide treatment for concussions and traumatic brain injuries, similar to a blood test that hospitals commonly use to evaluate suspected heart attacks, Koroshetz said. San Diego-based Banyan Biomarkers, which obtained the permission to market the blood test, is also now working with the Defense Department to shorten the turnaround time to under one hour.

"The key now is to use this sensitivity to evolve in more brain health and to protect athletes and keep soldiers out of harms way", said Kevin Hrusovsky, president and CEO of Quanterix.

Symptoms can occur at different times and also vary from person to person, these are the challenges of diagnosis concussions.

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