Synbio International Inc. has executed a Master Services Agreement with CRO Services Pty Ltd, a leading Australian clinical research organization, to conduct a proof-of-concept clinical trial evaluating FacialDx's proprietary NIMS technology. The AI-powered facial analysis system identifies early-stage features associated with Post-Traumatic Stress Disorder and Major Depressive Disorder, two prevalent mental health conditions affecting millions globally. This trial represents a critical step toward clinical validation, which is essential for regulatory engagement and commercial adoption of the technology.
The study will assess the accuracy, reliability, and clinical utility of the technology under real-world conditions. While internal non-clinical testing has shown promising results, this partnership with Resonance Health brings extensive experience in conducting clinical studies and supporting medical technologies through regulatory pathways, including prior engagement with the U.S. Food and Drug Administration. Conducting the trial in Australia offers meaningful efficiencies in cost and timeline while maintaining internationally recognized clinical and ethical standards.
Mental health conditions represent significant challenges for healthcare systems, with approximately 150 million primary care visits in the United States annually involving mental health discussions. Current screening methods rely heavily on subjective questionnaires and self-reporting, which can be influenced by stigma, recall bias, and clinician interpretation. The NIMS technology aims to supplement clinical judgment by providing objective biological data derived from facial analysis. If validated, it could become the world's first objective screening test for mental health conditions, enabling earlier identification and more consistent screening across clinical and corporate settings.
Beyond initial screening, the technology may be used repeatedly over time to assist clinicians in objectively assessing patient progress and treatment response. The proactive, non-invasive, rapid, and scalable technology has potential applications across clinical healthcare settings, corporate wellness programs, and high-risk industries where early identification could improve safety, resilience, and productivity. According to Claudio Solitario, Chief Executive Officer of Synbio International, "Clinical validation is the foundation for regulatory engagement and commercial deployment. The need for objective, scalable mental health screening tools has never been greater - Major Depressive Disorder is now one of the leading causes of disability among Americans aged 15 to 44."
The trial is expected to commence in early 2026 and conclude later in the year, with data intended to inform future regulatory submissions and guide commercialization strategy. The technology's development represents a significant advancement in addressing the limitations of current mental health screening methods, potentially transforming how these conditions are identified and monitored across diverse settings. More information about the company's approach to AI-driven medical diagnostics can be found at https://www.synbiointl.com.
