Biomarkers development company Banyan Biomarkers Inc revealed on Wednesday the receipt of the US Food and Drug Administration's marketing permit for the first blood test, the Brain Trauma Indicator, to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults.
The company said the Brain Trauma Indicator was reviewed and authorised for marketing in fewer than six months under the US FDA's De Novo premarket review pathway's breakthrough devices programme.
Availability of blood test for concussion will help health care professionals determine the need for CT scan in patients suspected of having mTBI and help prevent neuroimaging and associated radiation exposure to patients. This will help reduce need for CT scans, radiation exposure, added the company.
According to the company, the Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won't. The test results can be available within 3 to 4 hours.
This US FDA evaluated data from the company's multi-centre, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time and those who did not have intracranial lesions on a CT scan 99.6% of the time.
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