FDA clears blood-based biomarker lab test for traumatic brain injury

The FDA has cleared a traumatic brain injury blood test for commercial availability, paving the way for its distribution to hospitals in the United States.

According to a release from Abbott, the test will run on the company’s Alinity i laboratory instrument, which aims to provide clinicians with a rapid, objective way to assess mild traumatic brain injury (TBI) or concussion in individuals.

Alinity i can be employed within 12 hours of a suspected TBI. The test, which involves blood drawn from an arm, measures two biomarkers that, in elevated concentrations, are highly indicative of brain injury, Abbott said in the release.

Results can be achieved within 18 minutes to help clinicians assess concussion and triage patients. A negative test would enable health care professionals to rule out a CT scan, thereby eliminating longer wait times for treatment, per the release.

For those who sustain TBI, effects are variable from a few days post-injury or may be permanent, and individuals are more likely to sustain one or more TBI after the first instance. Misdiagnosis or lack of diagnosis can worsen short- and long-term outcomes; therefore, tools that enable rapid evaluation TBI or concussion are essential to proper treatment.

“Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test that can aid in concussion assessment,” Beth McQuiston, MD, medical director in Abbott’s diagnostics business, said in the release. “That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”