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FDA approves blood test that gauges mild concussion within 15 minutes

Abbott Laboratories campus facility in Lake Forest, Ill.
Nam Y. Huh/AP
Abbott Laboratories campus facility in Lake Forest, Ill.
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A new blood test to detect traumatic brain injuries within 15 minutes is being hailed as a “game changer” that could speed diagnosis and thus treatment for this most time-sensitive of injuries.

The U.S. Federal Drug Administration approved use of the test on Monday. The test, which measures the level of certain proteins in plasma, is administered via a handheld device.

Until now, doctors have relied on a mixture of questionnaires, CT scans and symptom-checking, which makes it hard to be precise.

Abbott Laboratories campus facility in Lake Forest, Ill.
Abbott Laboratories campus facility in Lake Forest, Ill.

“One of the most challenging aspects of diagnosing concussion today is there are no objective tests,” Dr. Farng-Yang Foo, a neurologist at NYU Langone Health’s Concussion Center told ABC News. “Currently, much of the diagnosis is by self-report of the patient, what the patient tells us. This makes it hard to make a diagnosis.”

In fact, about half of concussions go unreported or undetected, according to the U.S. Centers for Disease Control and Prevention.

The newly developed test can give a definitive answer by extracting blood plasma from a small sample, which is then inserted into the device. Certain molecular signatures in the blood indicate whether or not a traumatic brain injury has occurred, and can guide doctors to the next step.

If certain proteins reach a particular threshold, a CT scan could be required. It would help doctors decide whether the more costly test, which also introduces radiation into one’s system, would be warranted.

“If it comes out negative, then it gives clinicians and patients a sense of certainty that they can go home,” Dr. Beth McQuiston, medical director of the diagnostics arm of Abbott’s diagnostics arm, told The Chicago Tribune. “You don’t have to wait for a CT. You can get them home and give them peace of mind.”

The test is approved for those with mild traumatic bran injury symptoms and is an additional diagnostic tool to rule out the need for further testing, medical experts emphasized.

The potential game-changing aspect is literal, as Foo pointed out. Imagine being able to evaluate a bump on the head, right on the sidelines of, say, the football field.

“It would enable us to be able to quickly diagnose a concussion and to make quick clinical decisions such as pull an athlete out of a game or send them for imaging,” Foo told ABC News.