Published: Fri, February 16, 2018
Health Care | By Alice Shelton

FDA approves blood test to help detect concussions

FDA approves blood test to help detect concussions

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"Receiving marketing authorization from the FDA for the first blood test for TBI is a significant milestone that will transform how brain injury is managed". The test can be used to reduce radiation exposure to patients.

"These findings indicate that the test can reliably predict the absence of intracranial lesions and that healthcare professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI", the agency said. CT scans are a type of souped-up X-ray, which cost money and deliver radiation.

Hank Nordhiff, chairman and CEO of Banyan Biomarkers, said that the test would cost closer to US$150, compared to the US$800 to US$1,500 fee for a CT scan. The method of taking blood tests to diagnose brain injury was discovered some years ago but just yesterday the FDA approved it. For those who did not have a brain injury, the Banyan test was correct 99.6 percent of the time. "That's pretty important", Zafonte added. This fast approval was probably influenced by the Military necessity for such blood tests.

The test was approved as part of the FDA's Breakthrough Devices Program, which is a voluntary program for some medical devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications".

The test was assessed in a multi-center study involving 2,000 blood sampled from adults who had suspected concussions.

"It doesn't replace CT in all cases", said Alberts.

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But knowing when a traumatic brain injury may require intensive follow-up care is an inexact science.

Now computed tomography (CT) scan is used routinely in the evaluation of TBI, however, a majority of patients evaluated for mTBI do not have detectable intracranial lesions after having the scan.

"Over 90 percent of CT scans (for concussion) are negative".

Concussions are a big problem.

According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of almost 50,000 people. The scans expose patients to radiation, but in many patients with mild brain injuries including concussions, abnormalities don't show up on these imaging tests.

The human body can become damaged in a seemingly endless number of ways, but doctors have long known that brain trauma is particularly dire.

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