Abbott wins FDA nod for blood test to diagnose concussion

2020 02 06 19 40 5476 Football Player Concussion 400

Abbott has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a rapid blood test to assist with the diagnosis of concussions and other mild traumatic brain injuries.

The test identifies and measures specific proteins that are present in the blood after a traumatic brain injury. Clinicians can use the diagnostic to confirm or rule out the need for CT scans, according to Abbott.

The test uses plasma extracted from a small blood sample and runs on Abbott's handheld i-Stat Alinity platform. It can deliver results within 15 minutes of placing the plasma in the test cartridge, the company noted.

Abbott is also developing a whole blood test to help diagnose concussion at bedside and eliminate the need to separate plasma. The ultimate vision is to eventually create a 15-minute portable test that can be used in locations where people experience head injuries, such as at sporting events.

In addition, Abbott received the FDA breakthrough designation for a traumatic brain injury test to run on its Alinity i and Architect core laboratory instruments. The designation furthers its goal to provide concussion and traumatic brain injury analysis in additional healthcare settings.

Page 1 of 138
Next Page