DxDATA

OUR FOCUS ON NEUROSCIENCE

We are discovering ground-breaking solutions for preserving human brain health. Neurological conditions are the leading cause of illness and disability worldwide and shortening of human life. Our goal is to develop immediate and accurate diagnostic tests to protect the human brain that makes us who we are, and prolong the quality of human life across the globe.

INTRODUCING 30-MINUTES TIME TO RESULT CE-MARKED TESTS FOR SUSPECTED mTBI PATIENTS

What is Traumatic Brain Injury (TBI)?

Traumatic brain injury (TBI) can be mild or severe and is defined as damage to the brain resulting from an external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile. 1

How is TBI Diagnosed?

Imaging tests such as an MRI or CT scan can be performed, but these cannot detect all TBIs. This is of particular concern for those TBIs categorized as mild. Patients with mild TBI may suffer acute brain injury termed diffuse axonal injury (DAI), also known as “shearing injury,” which is not visible on standard CT and MRI scans. DAI is defined as “diffuse damage to axons in the cerebral hemispheres, in the corpus callosum, in the brainstem, and sometimes also in the cerebellum resulting from a head injury.” 2

Why TBI Biomarker?

Brain injury biomarkers such as GFAP and UCH-L1 have effectively shown to help health care providers in providing immediate standard of care to evaluate and treat patients.

GFAP (Glial Fibrillary Acidic Protein)

Role in TBI: GFAP is released when astrocytes are damaged, making it a specific marker for astroglial injury, which occurs in moderate to severe TBI.

Blood levels of GFAP increase soon after injury and remain elevated longer than UCH-L1, providing a longer window for detection.

UCH-L1 (Ubiquitin C-terminal hydrolase-L1)

Role in TBI: UCH-L1 is released into the bloodstream following neuronal injury, making it a reliable marker for neuronal damage in TBI. Elevated levels of UCH-L1 in the blood can be detected within hours after an injury, helping doctors diagnose mild to moderate TBI and differentiate it from non-brain injuries.

Why DRG TBI Biomarkers?

**DRG’s TBI Tests are to be used in conjunction with other clinical information to aid doctors in the evaluation of patients, 18 years or older, with suspected mTBI.**

DRG’s TBI Tests Performance Results in Comparison to An FDA-Cleared TBI Test :

Positive Percent Agreement (PPA): 100%

Negative Percent Agreement (NPA): 87.3%

Sources/Citations

1 Maas AI, Stocchetti N, Bullock R (August 2008). “Moderate and severe traumatic brain  injuries in adults.” The Lancet. Neurology. 7(8): 728–741. doi:10.1016/S1474-4422 (08)70164-9. PMID 18635021. S2CID 14071224.

2 Adams JH, Doyle D, Ford I, et  al. Diffuse axonal injury in head injury: definition, diagnosis and grading. Histopathology.  1989;15:49-59.