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Molecular test for mild traumatic brain injuries and concussion called ‘breakthrough device’ by FDA

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The new device could confirm certain blood biomarkers as signs that someone has suffered a mild traumatic brain injury

Israeli Laboratory Leads Western World In Blood Testing
FILE PHOTO - Vials of human blood at the Maccabi Health Services central labratory in Nes Tsiona, Israel.
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According to the Augusta Free Press a portable test that can diagnose signs of concussion and mild traumatic brain injuries (mTBIs) has received a ‘Breakthrough Device Designation’ from the U.S. Food and Drug Administration (FDA). The designation means the device will receive an expedited evaluation from the FDA once the product is deemed, by its creators, ready for public use.

The device was developed by BRAINBox Solutions, an innovator in the field of molecular diagnostics, which is focused on brain injuries. The company works alongside the Fralin Biomedical Research Institute at Virginia Tech. The device — which simultaneously tests for injury-related blood-protein biomarkers and evaluates highly sensitive imaging of the brain — is due for further testing at Virginia Tech. and its clinical partner Carillon Clinic.

“The FDA granted breakthrough designation of this new diagnostic approach from BRAINBox Solutions because it recognized how it benefits patients with an injury, especially those at greatest risk, including young people, athletes, soldiers, and the elderly, to be able to accurately and rapidly diagnosis mild traumatic brain injury,” said Michael Friedlander, the executive director of the Fralin Biomedical Research Institute and Virginia Tech’s vice president for health sciences and technology.

Mild traumatic brain injury is a term that will likely replace the word concussion in the coming years. Concussion itself refers to just the collection of symptoms commonly observed after the brain is forced into rotational acceleration, usually as a result of an impact to the head. Those symptoms often include dizziness, loss of time, light sensitivity, nausea, vertigo, irritability, and head aches.

The word concussion has often been used incorrectly to describe the actual injury to the brain. The injuries that cause concussion symptoms are best described as mild traumatic brain injuries. Some mTBIs might not illicit concussion symptoms, but they could still contribute to the process that results in chronic traumatic encephalopathy (CTE). Traumatic brain injuries (TBIs) include potentially fatal brain hemorrhages, like those that claimed the lives of UFC veteran Tim Hague, boxer Mike Towell, and Portuguese MMA fighter Joao Carvalho.

Stephen LaConte, an associate professor at Fralin Biomedical Research Institute, said BRAINBox’s test is so valuable because mTBIs are notoriously difficult to diagnose, especially if they do not provoke clear signs of concussion. LaConte also stressed that calling these injuries ‘mild’ is misleading, since they can have serious affects on the day-to-day functioning of the sufferer.

LaConte and his team are hoping that their tests will further prove that it is possible to detect mTBI soon after the time of injury, by evaluating a patient’s brain performance in real-time and analyzing it next to blood tests. The idea is that this testing will solidify the theories that certain proteins are released in the blood after a brain injury.

“A molecular test to identify traumatic brain injury in patients would be a breakthrough for care in an emergency setting,” said Damon Kuehl, an associate professor at the Virginia Tech Carilion School of Medicine. “The current tools for diagnosing TBI are limited right now. A quicker, more definitive diagnosis would help us get patients the care they need faster.”

If physicians are able to accurately diagnosis mTBIs in athletes, they would be able to proscribe better timetables for that athlete to return to training and eventually competition. In the weeks following an mTBI it is highly dangerous to continue activities that could result in a further mTBI. In that time, those suffering from a mTBI are also more susceptible to incur a second mTBI soon after the first.