US Food and Drug Administration Approves Concussion Blood Test

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US Food and Drug Administration Approves Concussion Blood Test

US Food and Drug Administration Approves Concussion Blood Test CNN reported in February 2018, that the FDA has approved a first of its kind blood test for helping to detect if an adult has a concussion. Motor vehicle accidents, falls at construction sites, explosions, and other violent accidents can cause a traumatic brain injury (TBI). Many TBI victims also suffer a concussion which can be mild, moderate, or severe.

Currently, concussions are evaluated by examining a patient’s symptoms and by imaging tests. The main diagnostic tool is a CT scan. According to the CEO of Banyan Biomakers, the makers of the new blood test, CT scans have drawbacks. Patients are exposed to radiation levels 200 times more intense than chest X-rays. Many CT scans don’t accurately evaluate the concussion.

The new blood test for concussions

The new blood test, called a Brain Trauma Indicator Test, evaluates two biomarker proteins (GFAP and UCH-L-1) which are released when a brain trauma occurs. The high levels of these proteins appear within 15 to 20 minutes of the injury. The blood tests should be taken within 12 hours of the injury. It takes a few hours for the results to be reported.

The test is part of an initiative by the FDA to reduce undue exposure to radiation imaging tests. The FDA thinks that the blood test will reduce the need for imaging tests by one-third.

The new FDA blood test is also likely to be much less costly. The new blood test for concussion costs about $150 as compared to about $1250, on average, for a CT scan.

The FDA approved the blood test after conducting a clinical study. The study:

  • Examined 1,900 samples of blood from people thought to have suffered a mild TBI or a concussion.
  • Was only conducted on adults, not children.
  • Was 97.5% accurate in detecting concussions and 99.6% accurate in ruling out a concussion

Researchers still need to do more studies to diagnose brain injuries. Tests need to be able to measure for the incidence of an injury after the brain has healed and need to detect physical contact that doesn’t cause concussions but does cause brain damage. How the levels of the two protein biomarkers affect a patient’s progress also needs to be examined.

The Gladiators in Suits at the Rocky McElhaney Law Firm are more than just advocates. We regularly work with physicians and healthcare professionals to understand the most current treatments that help can help clients who have concussions. To make an appointment with a respected Nashville attorney, please call us at 615-246-5549 or fill out our contact form. We have offices in Nashville, Henderson, and Knoxville.