Breakthrough Test for Brain Injury Receives FDA Clearance

Image from Abbott

Abbot, a company that makes everything from baby formula to cardiovascular devices, recently secured FDA clearance for a traumatic brain injury (TBI) diagnostic test. This handheld tool is both portable and it provides results in 15 minutes, providing important diagnostic data that will quickly inform healthcare providers whether the patient needs a brain CT or MRI. The developers of this device are hoping it will help injury victims not only get the help they need in a timely manner, but also save lives in the process.

What is traumatic brain injury?

A traumatic brain injury, or TBI, occurs when the head is subject to a violent jolt, or sudden acceleration or de-acceleration. Anything that can jostle or bruise the brain can cause nerve and vessel damage, leading to short- and long-term injury. TBIs can occur from assaults, sports injuries, car accidents, or military combat. Symptoms of TBI can include headaches, chronic pain, depression, memory issues, and changes in personality.

For some patients, symptoms of a TBI may not present themselves until hours or days after the initial injury, causing a delay in treatment.

“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.”

Abbot’s new device aims to bridge that gap.

How does the device work?

The device, called the i-STATTM AlinityTM, relies on a blood test rather than imaging diagnostics. The i-STAT, using a small sample of blood from the patient’s arm, checks the blood for two biomarkers associated with TBI: UCH-L1 and GFAP. These markers are elevated in patients with traumatic brain injuries. If the device shows a negative result, it rules out the necessity for a CT scan. If the device shows a positive result, the patient will need medical attention for further treatment.

“Evaluating brain injuries is complex – and research shows that we only catch about half of those who show up to the hospital with a suspected TBI,” says Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco. “And beyond those who go to the hospital for a suspected TBI, many more never do. A test like this could encourage more people to get tested after a head trauma, which is important, because not receiving a diagnosis can be dangerous and may prevent people from taking the necessary steps to recover safely.”

Although Abbot’s test relies on use of a centrifuge, they are currently developing a device for whole blood, which means the device could be used outside of a medical setting – in military settings, during sporting events, or anywhere a serious injury occurs.

The Richmond injury attorneys at Phelan Petty protect the rights of TBI patients and their families throughout Virginia. We help you seek compensation when you are injured due to someone else’s negligence. To set up a free case consultation, give us a call today at 804-980-7100 or use our contact form to leave us a message.