Medibio’s (ASX:MEB, OTCMKTS:MDBIF) depression diagnostic test has achieved excellent performance in a prospective study, ahead of its FDA confirmatory study.
The company has developed an objective testing system to assist in the screening, diagnosis and treatment effectiveness of depression, chronic stress and other mental health disorders.
Sleep and other circadian measures provide a powerful lens into mental wellbeing. Medibio’s solution leverages the science linking sleep and mental health.
The MACH-3 study was designed as the first prospective assessment of the Medibio-DX depression algorithm under more challenging conditions recommended by the FDA.
These conditions are aligned with product deployment in the primary care setting, an important market in the U.S., where a tremendous need exists for improving the diagnosis of depression.
The study has been successfully concluded, with an overall accuracy of 82%, specificity of 84%, and sensitivity of 78%.
These results represent an outstanding study outcome, far exceeding current clinical diagnostic performance.
In the primary care setting, where more than half of depression is diagnosed and treated, accuracy ranges from 30-50%.
This is a pivotal achievement for Medibio as it continues to meet and exceed key milestones.
The company is entering confirmatory validation study with the FDA this month, and is well positioned for FDA clearance next year.
According to the World Bank, depression and anxiety disorders cost the world nearly US$1 trillion annually.