TrivarX’s Single-Lead ECG Algorithm Hits 97% Sensitivity in Veteran Depression Trial

Clinical Trial Validates Innovative Mental Health Screening

TrivarX Limited (ASX, TRI) has unveiled promising results from a clinical trial assessing its novel single-lead ECG algorithm designed to detect current major depressive episodes (cMDE) in US veterans. Conducted in partnership with the Greater Los Angeles Research and Education Foundation and the US Veterans Affairs Greater Los Angeles Healthcare System, the study highlights the technology’s potential to transform mental health screening by offering an objective, data-driven approach.

The trial enrolled 60 veterans suspected of sleep apnoea, with 57 participants included in the final analysis. The single-lead algorithm demonstrated a remarkable 97% sensitivity in identifying depressive episodes, significantly outperforming traditional subjective screening methods. Specificity was moderate at 64%, indicating some false positives but underscoring the algorithm’s strong ability to flag at-risk individuals early.

Addressing Veteran Mental Health Challenges

Beyond depression detection, the study reaffirmed the high prevalence of coexisting conditions such as post-traumatic stress disorder (PTSD) and sleep disturbances among veterans; 72% and 77% respectively. This intersection of mental health challenges underscores the urgent need for scalable, objective tools that can be embedded into existing clinical workflows without adding operational complexity.

TrivarX’s technology leverages heart rate and heart rate variability metrics from a single ECG lead, enabling seamless integration into sleep clinics and other healthcare settings. This compatibility aligns closely with the US Department of Veterans Affairs’ priorities for early identification and improved access to mental health care, potentially facilitating population-level monitoring and personalised intervention strategies.

Commercial and Regulatory Implications

The trial results not only validate TrivarX’s single-lead algorithm but also reinforce the company’s broader commercial strategy. The algorithm’s performance was consistent with, and in some cases exceeded, that of the company’s established MEB-001 asset, which requires more complex multi-lead ECG data. This positions TrivarX favorably for regulatory approvals and adoption within large healthcare systems.

Management expressed optimism about the technology’s role in bridging gaps in mental health screening. Principal Investigator Dr Jennifer Martin highlighted the algorithm’s ability to detect symptoms in patients who might otherwise go unscreened, while Non-executive Chairman David Trimboli emphasised the milestone’s significance in validating real-world performance within a high-need veteran population.

As mental health continues to be a critical focus for healthcare providers and policymakers, TrivarX’s innovation offers a promising pathway to more objective, accessible, and scalable screening solutions.