FDA approves first blood test to help diagnose concussions

Share

While the blood test can not now detect concussions conclusively, it does allow doctors to scan brain cells for proteins that indicate brain bleeding and other neurological injuries after a blow to the head, the Associated Press reported. Results of the blood test is available within three and four hours.

The US Food and Drug Administration has, for the first time, approved a blood test to help detect concussion in adults.

The test could also help reduce costs significantly. Levels of these blood proteins after concussion can help predict which patients may have intracranial lesions visible by CT scan and which will not.

The Banyan Brain Trauma Indicator will show markers that indicate a person really needs a CT scan, which means that it will precede a CT scan unless the person shows signs of extreme trauma. These findings indicate that the test can reliably predict the absence of intracranial lesions. Use of the blood tests could begin as soon as this year. The Pentagon financed a 2,000-person clinical trial that led to the test's approval.

The blood test for concussions and other traumatic brain injuries will initially be used in emergency rooms and could eventually be used to treat possible head injury victims in sports and the military, the AP reported. As a part of the Breakthrough Devices Program conducted by the FDA, the government health organization has authorized and reviewed for the marketing of Banyan Brain Trauma Indicator for less than 6 months. Health care professionals now have the opportunity to incorporate the tool into the standard of care for patients in order to rule out the need for a CT scan in at least one-third of those suspected to have mTBI. Of these cases, concussion-related head injuries contributed to the deaths of almost 50,000 patients.

Patients with a positive test would need a CT scan to confirm the results and determine if surgery or other treatment is needed. Of these, almost 50,000 people died. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain's normal functioning.

When compared with a CT scan, the blood test was 97.5% as effective in detecting concussion and 99.6% effective in ruling out concussion.

"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", Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the release.

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

Share