TrivarX (ASX: TRI) has delivered positive results from a US-based clinical trial that demonstrate clinically meaningful, objective detection of current major depressive episodes in veterans using the company’s single-lead electrocardiogram (ECG) technology.
The study screened veterans with suspected sleep apnoea and showed the single-lead algorithm achieved high sensitivity and solid specificity when benchmarked against gold-standard clinical assessments.
TrivarX’s ECG technology performs sleep staging and mental health screening from a single electrocardiogram lead, enabling integration into routine sleep studies without additional hardware or workflow disruption.
Conducted in partnership with the Greater Los Angeles Research and Education Foundation, and the US Veterans Affairs Greater Los Angeles Healthcare System, the trial aligns the program with priority veteran mental health initiatives, and the results reinforce the technology’s potential role in mental health screening.
High Diagnostic Performance
The trial assessed TrivarX’s single-lead algorithm against clinician-administered Mini International Neuropsychometric Interviews to evaluate its ability to identify a current major depressive episode.
Analysis included data from 57 of 60 enrolled participants that showed the single-lead algorithm achieved sensitivity of 97 percent and specificity of 64 percent.
The company’s established MEB-001 asset delivered sensitivity of 88 percent and specificity of 68 percent.
The results closely matched performance observed in TrivarX’s earlier Phase 2 program, which analysed 295 independent datasets and provided prior validation of both algorithms.
48 of the trial participants (80%) were male, with the remaining 12 patients female.
Management said the comparable performance between the single-lead algorithm and MEB-001 provides additional validation for a simplified, scalable screening platform.
Veteran Mental Health Need
The study also highlighted the high prevalence and co-existence of sleep disturbance, depression, and post-traumatic stress disorder among participating veterans.
Data showed current major depressive episodes co-existed with post-traumatic stress disorder in more than 70 percent of affected participants, underlining the need for objective and scalable screening tools.
TrivarX said the ability to embed screening into existing Veterans Affairs sleep clinics without adding operational burden directly supports early identification and population-level mental health initiatives.
Single-Lead Technology
TrivarX designed the single-lead algorithm as an extension of its lead asset MEB-001, extracting clinically relevant signals using only heart rate and heart rate variability metrics.
The company said the trial outcomes strengthen its commercial positioning by demonstrating real-world performance in a high-need clinical population.
“This novel approach capitalises on information that is collected as part of routine tests for sleep disorders, and adds to our ability to detect mental health symptoms in patients who might not otherwise undergo mental health screening,” principal investigator Dr Jennifer Martin said.
“These results represent a significant clinical validation milestone for TrivarX and provide compelling evidence of the real-world performance of our single-lead ECG algorithm in a high-need veteran population,” non-executive chair David Trimboli added.
“Achieving sensitivity of 97% for the detection of current major depressive episodes demonstrates the algorithm’s ability to objectively identify individuals who may otherwise remain undiagnosed using traditional screening approaches.”
