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Defense Dept Funding Fast TBI Diagnostics Kit

Road-side bomb

Road-side bomb explosion in Afghanistan (Stephen Szczurek, U.S. Air Force).

5 July 2019. A medical device company in Finland is receiving a U.S. Department of Defense grant to develop a kit for soldiers in the field to quickly detect concussions. The DoD’s Combat Casualty Care Research Program is awarding Medicortex Finland Oy in Turku $1.1 million to develop a prototype test kit that reveals mild traumatic brain injuries, also called concussions.

Traumatic brain injuries or TBIs such as concussions, result from blows to the head, including those from contact sports, or penetrations of the skull that disrupt normal brain functions. Military service members in combat are particularly vulnerable to TBIs, which according to the web site often result from improvised explosive devices, such as road-side bombs experienced by U.S. troops and their allies in Iraq and Afghanistan. According to DoD statistics, some 384,000 service members were diagnosed with TBIs since 2000, with more than 8 in 10 (82%) TBIs rated as mild, and the bulk of those injuries suffered by Army soldiers.

The Medicortex technology aims to quickly detect biomarkers, or biological indicators, of traumatic brain injuries in accessible bodily fluids, like saliva or urine. The company says impacts to the head cause changes in the brain’s chemistry. The trauma releases glutamates, a type of neurotransmitter chemical, and calcium in the brain that disrupts neurons and supporting astrocyte cells in the brain. The trauma also breaks down the blood-brain barrier, allowing characteristic proteins and enzymes indicating brain cell damage to enter the blood stream.

Medicortex’s founder and CEO Adrian Harel with company colleagues describe this process in a 2016 paper published in the journal eNeuro. Their analysis identified 12 TBI biomarkers, most of which are elevated for a short time following the injury’s occurrence.

The company’s hand-held concussion test kit, called ProbTBI, uses disposable chemically-treated test strips dipped in saliva or urine samples. If the characteristic biomarkers are present in the samples, the test strips turn color. The test can be administered by non-clinical staff, such as Army medics or sports team trainers, and do not require specialized equipment.

Medicortex is testing its concussion detection technology in a clinical trial to determine its feasibility for detecting TBI biomarkers. As reported by Science & Enterprise in December 2017, the trial recruited 160 participants at a Turku hospital with suspected TBI, as well as those with limb-bone fractures and healthy volunteers with no history of head trauma for comparison. The study team is taking blood, saliva, and urine samples from the group over a one-year period, with the samples analyzed by the Medicortex test kit, compared to high-performance liquid chromatography to identify the characteristic TBI biomarkers.

The company says DoD awarded the $1.1 million grant through its Combat Casualty Care Research Program. That program aims to improve the odds of military service members to survive combat injuries, particularly head and lung wounds where early diagnostics and care can make a difference between life and death.

In a company statement released through BusinessWire, Harel says the funds, “will enable us to strengthen our research team and expand our translational programs from the clinical sample collection to a prototype kit.” Harel adds, “From our public searches Medicortex Finland is the only Finnish company in the last 12 years to get a DoD grant.”

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