T-NeuroDx, a biotechnology company focused on advancing early diagnostics for neurodegenerative disease, today announced the branding of AlzheimerGuard, a proprietary blood-based biomarker assay designed to detect Alzheimer’s disease years before clinical symptoms appear, representing a major step forward in the development of accessible early detection tools for Alzheimer’s disease.

The AlzheimerGuard assay detects hiT Cells™, a specific population of aberrant immune T cells in the blood stream that are associated with the mechanism of disease initiation and progression. The foundational research underlying the technology was led by Dr. Christopher Wheeler, Chief Science Officer of T-NeuroDx, and published in Proceedings of the National Academy of Sciences (PNAS) and showed that hiT Cells decline as Alzheimer’s disease progresses. Monitoring the cells through a simple blood test may allow clinicians and researchers to detect disease-related biological changes long before cognitive symptoms become apparent, providing a preclinical window of 13 to 20 years for intervention.

“Early detection is one of the most critical unmet needs in Alzheimer’s research,” said Michael Reed, CEO of T-NeuroDx. “AlzheimerGuard represents a revolutionary approach for identifying disease risk earlier and enabling new strategies for clinical trials, prevention, and treatment.”

T-NeuroDx has recently been awarded a Small Business Innovation Research (SBIR) grant, which is supporting the next phase of biomarker validation in a collaboration with the University of Southern California’s Alzheimer’s Therapeutic Research Institute (USC ATRI). Through this federally funded program, the company will analyze over 400 additional patient samples to further confirm the performance of the AlzheimerGuard assay and expand the underlying clinical dataset supporting its development. The resulting data will contribute to future peer-reviewed publications and help advance the diagnostic toward biomarker validation and clinical application.

“By expanding the dataset and validating this biomarker across a larger patient population, we are moving closer to providing clinicians and researchers with a powerful tool for early Alzheimer’s detection,” Dr. Wheeler said. Additional results from the SBIR-supported research are expected to be published in the near future.