The Neural-Injury Assessment Test™ is performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory, reflecting compliance with rigorous federal and industry standards for laboratory quality, analytical performance, and ongoing quality assurance. The biomarkers included in the test are supported by a growing body of scientific literature and research related to traumatic brain injury, neurotoxicity, neuroinflammation, and neurological health.

The Neural-Injury Assessment Test™ is performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratory. The biomarkers included in the test are supported by a growing body of scientific literature and research related to traumatic brain injury, neurotoxicity, neuroinflammation, and neurological health.

As part of CLIA and CAP requirements, the laboratory validates its testing methods, maintains comprehensive quality control procedures, participates in proficiency testing when applicable, and undergoes routine inspections to help ensure testing continues to meet established performance standards.

These certifications help ensure that laboratory testing is performed in a controlled, highly regulated environment using validated analytical methods.

FDA approval and CLIA validation serve different regulatory purposes and should not be confused.

The FDA regulates commercially manufactured diagnostic devices and test kits. In contrast, Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) regulate how clinical laboratories develop, validate, perform, and maintain laboratory testing.

The Neural-Injury Assessment Test™ is a Laboratory Developed Test (LDT) performed exclusively within Brazos Neuroscience's CLIA-certified and CAP-accredited laboratory. Unlike commercially distributed FDA-cleared diagnostic kits, Laboratory Developed Tests are analytically validated by the laboratory to demonstrate that they produce accurate, reliable, and reproducible results for their intended clinical use.

As part of this validation process, laboratories evaluate analytical performance characteristics such as accuracy, precision, reproducibility, reportable range, specimen stability, linearity, quality control, and potential sources of analytical interference. CLIA and CAP also require ongoing quality assurance, routine inspections, and proficiency testing to help ensure continued laboratory performance.

Importantly, FDA approval and CLIA/CAP validation represent different regulatory pathways. With regard to Laboratory Developed Test (LDT) reporting, federal regulations require laboratories to include a statement indicating that the assay was developed by the laboratory, along with information describing the method and performance characteristics necessary for clinical use. Accordingly, reports for the Neural-Injury Assessment Test™ include the following required statement: 'This test was developed and its performance characteristics determined by Brazos Neuroscience. It has not been cleared or approved by the U.S. Food and Drug Administration.'

This statement reflects the distinct regulatory framework governing Laboratory Developed Tests and should not be interpreted as an indication that the test is less scientifically rigorous or less reliable than an FDA-cleared or FDA-approved test. Rather, it reflects the regulatory pathway under which the test was developed, analytically validated, and is performed within a CLIA-certified and CAP-accredited laboratory.

Like all laboratory testing, Neural-Injury Assessment Test™ results should be interpreted by a healthcare provider alongside a patient's medical history, symptoms, physical examination, imaging, and other relevant clinical information."

The Neural-Injury Assessment Test™ is designed to objectively measure proteins associated with neurologic injury-related biological processes, including astroglial injury, neuronal injury, axonal injury, neuroinflammation, and tissue recovery. Biomarkers such as GFAP, UCH-L1, S100B, and neurofilament proteins are analytically measurable and have been associated in the scientific literature with neurologic injury and recovery trajectories.

The test is designed to provide accurate, reliable, and clinically meaningful biological information to support clinical decision making. It is not intended to function as a standalone diagnostic tool but rather as one component of a broader clinical evaluation interpreted alongside a patient's medical history, symptoms, physical examination, imaging studies, and other relevant clinical information.