Abbott blood test to evaluate mild concussions wins FDA clearance. ‘You don’t have to wait for a CT.’ 

Chicago Tribune

January 11, 2021

Also covered in ABC NewsMass Device IFL ScienceEverett PostBolly Inside and Daily News

Doctors soon will have a new way to evaluate patients with concussions: a rapid blood test made by Abbott Laboratories that has been cleared by the U.S. Food and Drug Administration.

It’s an advancement that could eliminate the need for some patients to get costly CT scans and the radiation exposure that accompanies them.

The test works by measuring proteins that can be present in the blood after a traumatic brain injury. It uses blood drawn from the arm and can be performed on a handheld device. It can produce results in 15 minutes, after plasma is extracted from the blood, which typically takes place in a lab. The test has been approved for use in people ages 18 years and older.

The FDA approved the test as a way for doctors to rule out the need for a CT scan, which is often necessary to figure out whether there’s brain tissue damage after an injury, Abbott announced Monday. If the blood test doesn’t detect the proteins or detects very low levels of them, it’s unlikely the patient has tissue damage.

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

Patients who test positive will still likely need CT scans. The test is approved for patients with suspected mild traumatic brain injuries, not those exhibiting severe symptoms.

Nearly 3 million people in the U.S. went to emergency rooms, were hospitalized or died from traumatic brain injuries in 2014, according to the Centers for Disease Control and Prevention. The injuries are typically caused by bumps, blows or jolts to the head because of falls, being struck by objects or motor vehicle accidents.

Most traumatic brain injuries are mild ones, commonly called concussions. Symptoms of mild injuries may include headaches and dizziness, while people with severe injuries may experience long periods of unconsciousness, memory loss and other problems.

Abbott expects that the test will be the first of its kind available for everyday clinical use. The FDA approved a similar blood test in 2018, but that test, made by Banyan Biomarkers, was never made widely available to hospitals and doctors, McQuiston said. It also didn’t produce results rapidly. Banyan licensed its technology to Abbott.

McQuiston said more than 100 Abbott scientists in north suburban Abbott Park spent the last six years working to develop the company’s test. The test will run on Abbott’s i-STAT Alinity handheld device.

The test accurately detects positive results 95.8% of the time and accurately detects negative results more than 99% of the time, according to Abbott.

McQuiston said she didn’t have information about what the test will cost, but “it will be many times lower than the cost” of CT scans, which can cost hundreds to thousands of dollars depending on where they’re done. She also didn’t have a specific time frame for when it will be sold, but said Abbott plans to work “quickly” to get the tests to hospitals and emergency departments.

It’s a test that looks “promising” for helping doctors decide when a patient may not need a CT scan, said Dr. Cynthia LaBella, a professor of pediatrics at Northwestern University’s Feinberg School of Medicine and medical director for the Institute for Sports Medicine at Lurie Children’s Hospital.

“I think where this can be helpful is in that setting where you’re trying to decide, do I need to scan this person,” LaBella said. Though the test is only approved for adults now, Abbott is looking to research its effectiveness for children.

Still, she cautioned that the test cannot be used to diagnose a concussion or more severe traumatic brain injury. A person can test positive for reasons other than a brain injury and would need imaging to know for sure what’s going on. And a person who tests negative could still have a concussion, which doesn’t include tissue damage, she said.

LaBella said she hopes that one day, the technology will evolve to the point where the tests could be done at the bedside or even on the field, after a player is hit in the head.

A negative result could reassure players and their parents that they don’t have bleeding in their brains, meaning they wouldn’t have to immediately go to an ER, and could instead head home and follow-up with their doctors later as long their symptoms didn’t worsen, she said.

Abbott is working to develop a test that could produce rapid results in health care settings, without the need to first separate the blood and plasma. The company hopes to develop a test that can be used outside of health care, such as at sporting events.

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