This new test, called the Brain Trauma Indicator, was developed to help tell if there is a need for such scans after a person has suffered a head injury, reducing the need for unnecessary CT tests and cutting down on radiation exposure.
In a press release, FDA Commissioner Scott Gottlieb said that this product could save the health care system money by preventing unnecessary neuroimaging tests. "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".
The test, known as the Banyan Brain Trauma Indicator, could help reduce the need for CT scans, which would decrease radiation exposure to patients, the FDA said.
Traumatic brain injuries affect an estimated 10 million people globally each year; at least 2 million of them are treated in US emergency rooms.
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The test detects two proteins present in brain cells that can leak into the bloodstream following a blow to the head. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. This exposes patients to radiation and drives up healthcare costs.
"A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members overseas who need access to quick and accurate tests", said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. The Brain Trauma Indicator analyzes the levels of UCH-L1 and GFAP, proteins that are elevated in patients with traumatic brain injuries.
A CT scan or MRI would still be needed if a patient experiences major changes in function after a head injury. Test outcomes can be accessible inside 3 to 4 hours.
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. Researchers compared mTBI blood results to results generated by a CT scan and quickly noted the Brain Trauma Indicator's efficacy-it was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and the absence of intracranial lesions 99.6 percent of the time.
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Because of the US military's role in the new test's development, Nordhoff noted that clinical trials have enrolled adults only.
"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. 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.
As the company brings on two companies to produce a smaller, faster blood-testing instrument, Nordhoff predicted that within two years, the assay will be available for rapid use in ambulances, emergency departments and in athletic training rooms.
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