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tiptrot.com May 21, 2018


First blood test to detect concussions is approved

16 February 2018, 02:40 | Nichole Osborne

Blood Test for Concussion OK'd

The Blood Tests To Diagnose Brain Injury Are Now Approved By The FDA

The U.S. Food and Drug Administration today allowed advertising of the main blood test to assess mellow very bad cerebrum damage (mTBI), regularly alluded to as blackout, in grown-ups.

Blood test to diagnose concussions quickly will be welcomed in the medical and sports worlds. Test results can be available within three to four hours. "The FDA's audit group worked intimately with the test engineer and the U.S. Branch of Defense to assist a blood test for the assessment of mTBI that can be utilized both in the mainland U.S. and also outside U.S. research centers that administration the American military".

In a press release, FDA Commissioner Scott Gottlieb said that this product could save the health care system money by preventing unnecessary neuroimaging tests.

For more information, see the entire story below.

The test should save money and reduce a patient's exposure to radiation, according to the FDA.

Almost 2.8 million people visited USA emergency rooms in 2013 because of concussion or other traumatic brain injuries, according to the Centers for Disease Control and Prevention. When compared to a CT scan, the Brain Trauma Indicator was 97.5 per cent as effective in detecting concussion and 99.6 per cent in ruling out concussion, according to the online article published on Feb 14. It is manufactured by Banyan Biomarkers Inc., in Alachua, Florida.

The blood test helps fill a need when it comes to diagnosing concussions.


Banyan's blood test is created to cut the need for CT scans. Being able to predict whether patients have a low probability of intracranial lesions can help healthcare professionals manage patients and decide whether or not to perform a CT scan.

The FDA approved the test as part of its breakthrough devices program after evaluating a clinical study of 1,900 blood samples from people thought to have concussion or mild traumatic brain injury.

"It's a time saver, a cost saver and there's no radiation exposure", Zafonte said.

Levels of the blood proteins after mTBI can help predict patients that could have intracranial lesions visible by CT scan and those that won't.

In fact, Banyan has partnered with another company, Quanterix, to help develop a test that could eventually detect the impact of repeated hits.

Symptoms can occur at different times and also vary from person to person, these are the challenges of diagnosis concussions. It could rule out the need for a CT scan in at least one-third of those suspected of having a concussion, the FDA said.



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