An extensive research and development (R&D) program by mental health technology company TrivarX (ASX: TRI) has advanced the company’s proprietary artificial intelligence-backed algorithm MEB-001 for the screening of current major depressive episode (cMDE).

The algorithm can accurately conduct sleep staging and screen for cMDE in subjects through a single-channel electrocardiogram, using heart rate and heart rate variability metrics as biomarkers.

Proof-of-concept testing on 295 subjects in a Phase 2 sleep signal analysis for cMDE produced results including high sensitivity (87%) and specificity (67%) that are considered key parameters required to build an effective screening tool.

Increased applications

TrivarX non-executive chair David Trimboli said the newly developed algorithm would present increased potential applications, including multiple hardware platforms and scenarios outside of sleep centres.

“MEB-001 has been shown to deliver promising performance metrics, which will be further validated across data generated from our upcoming pivotal trial,” he said.

“It will also have the potential to lead to US regulatory clearance, which will strengthen our commercialisation opportunities.”

Mr Trimboli said the requirement for only two biomarkers could potentially increase patient reach for MEB-001 and unlock opportunities in remote patient monitoring, specialist consumer devices and consumer wearables.

Work is now underway to advance a series of sponsored clinical trials, testing and licensing opportunities using MEB-001.

Pre-submission meeting

In September, TrivarX requested a pre-submission meeting with the US Food and Drug Administration (FDA) for the proposed pivotal clinical trial to test the effectiveness of MEB-001 in screening for cMDE.

The meeting is expected to finalise the trial protocol and is the final requirement before TrivarX can submit the algorithm for FDA approval via the De Novo pathway.

Several prominent US sleep centres and research organisations are reported to have expressed interest in collaborating on the trial, which Mr Trimboli said could help fast-track completion at high-volume sites.

The pre-submission meeting will be held before year-end, with the trial to commence soon after.

There is currently no clinically backed screening solution for cMDE, which is commonly underdiagnosed or misdiagnosed.