New Traumatic Brain Injury Blood Test Could Change Standard of Care

At 13 years old, Zack Lystedt was a talented football player who lived and breathed the sport. So much so that even after being hit in the head, he begged to continue playing. But that one small decision changed his life forever, according to a special report by the CDC.

The initial hit caused a traumatic brain injury (TBI), and every subsequent hit exacerbated Zack’s injury.  By the time the game was over, he was in noticeable pain. Zack was airlifted and rushed into emergency surgery to relieve the pressure on his brain. He suffered from multiple strokes, spent 7 days on a ventilator, and 3 months in a coma.

It was another 9 months before he could speak. Thirteen before he could move a limb. Twenty before he could eat without a feeding tube. And almost three years before he could even stand on his own two feet, with help.

Had Zack been diagnosed with his TBI sooner, this may have all been prevented. Thanks to recent advancements in technology, this will soon be possible.

A new rapid handheld TBI blood test can detect a TBI within 15 minutes after blood plasma is placed in the test device, using biomarkers that are released in response to a brain injury. Blood tests are often preferred by physicians for diagnosis because they provide objectivity and speed, which is not always true of a CT scan. Additionally, not all brain injuries may be visible on a CT scan, and initial diagnosis may be delayed because physical damage to the head is not always apparent.

What’s more, this traumatic brain injury blood test can be administered anywhere – from the sidelines of a football game to an urgent care center. This will allow patients to spend less unnecessary time in the ER, which is especially beneficial given the current COVID-19 pandemic restrictions. And when it comes to diagnosing a TBI, timing is critical.

Why a Rapid TBI Test Matters

TBIs are typically diagnosed by first examining cardiac and pulmonary function, performing a neurological assessment using the Glasgow Coma Scale (GCS), and then administering a CT scan,  all of which can take time. But the new TBI blood test could potentially reduce the need for CT scans by 40%, saving precious time needed to make the necessary diagnosis.

“A blood test that can rule out the need for a CT scan has huge implications from both a time and cost perspective for patients,” Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco recently told Forbes. The sooner we can diagnose TBI, the sooner we can begin treatment, which is paramount in helping patients return to their normal lives.”

In January, the i-STAT™ Alinity™ rapid handheld TBI blood test device received 510(k) clearance and may be available on the market within 90 days of FDA notification. It’s designed to identify the presence of two biomarkers in the blood that have been found to be present in high concentrations when the brain is injured: Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP).

The TBI test was developed by Abbott in collaboration with the U.S. Department of Defense through the U.S. Army Medical Research and Development Command, as well as the U.S. Army Medical Material Development Activity. Additionally, the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) were able to showcase how the device would be helpful to TBI patients.

The Future of Biomarkers and Brain Injury

There is also current research aimed at determining the presence of several other biomarkers that may be correlated with TBIs. A 2021 study in the International Journal of Molecular Sciences examined the potential for acutely altered plasma miRNAs to serve as diagnostic biomarkers for TBIs in a group of 31 rats. They saw an increase in the presence of miR-9a-3p, miR-136-3p, and miR-434-3p corresponding to the severity of the TBI.

Interestingly, miR-9a-3p was also found to be present in football players who had been participating in the sport for at least 6 years, and with a 41% previously reported concussion rate. Additionally, it was present in human plasma samples in levels 6.5-fold with severe TBI (sTBI) compared to mild TBI (mTBI), suggesting that it may potentially have a strong correlation to brain injury.

Incidences of TBI are on the rise – specifically 53% between 2006 and 2014. In 2014, the CDC reported that 2.87 million TBI cases occurred in the United States alone, 837,000 of which are pediatric cases. Around 13.5 million people are living with a disability resulting from their TBI. The combined direct and indirect cost of living with a TBI total to around $76.5 billion annually.