Sunday, 27 May, 2018

FDA approves first blood test to help diagnose concussions

Blood Test for Concussion OK'd FDA approves first blood test to help diagnose concussions
Marlene Weaver | 15 February, 2018, 16:09

The United States Food and Drug Administration approved blood test to detect concussions in people and more quickly identify those with possible brain injuries.

"The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than six months as part of its Breakthrough Devices Program", the FDA said in a statement.

Today's action supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging - an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose.
In addition to the expense - a CT scan of the brain averaged about $1,200 in 2015 - an average CT scan of the head exposes a patient to about two millisieverts of radiation - about the equivalent of 100 to 200 chest X-rays.

The approval goes to San Diego diagnostics developer Banyan Biomarkers. Results, available within four hours, can help doctors decide whether to perform a CT scan. Elevated levels of UCH-L1 and GFAP in the blood have been shown to effectively correlate with patients that have intracranial lesions. The company's test, called Banyan BTI (short for brain trauma indicator), measures the levels of two proteins that the brain releases into the blood in the hours following a head injury. That means going forward, the Banyan test will be the basis upon which the FDA reviews new blood tests for brain injury developed by Banyan or other companies. Almost 2.8 million people visited US emergency rooms in 2013 because of concussion or other traumatic brain injuries, according to the Centers for Disease Control and Prevention. Of these cases, concussion-related head injuries contributed to the deaths of almost 50,000 patients.

Rising US supply knocks oil prices for a third day
Back in 2014, USA shale production was growing so fast that it ended up crashing the market. But in thin post-close trading, US crude futures were down 34 cents at $58.95 a barrel.

Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, and other brain injury experts say the test isn't sensitive enough to rule out concussions. The test accurately predicted the presence of brain lesions 97.5% of the time, proving its mettle as a new tool in brain injuries. That limitation in research data dictated the FDA's approval of the blood test's marketing to adults.

Most patients evaluated for concussion have a negative CT scan, and this new blood test option would help reduce the need for these scans and prevent unnecessary neuroimaging and radiation exposure for patients with suspected mild traumatic brain injury, according to the FDA.

"I think there will be some off-label usage" in children with TBI, said Nordhoff, referring to physicians' legal use of products in different ways or on different populations than those for which the products have been approved by the FDA.

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