Medibio (ASX:MEB) has announced that a DSM-V 1 diagnosis will be included as a primary comparator for the purposes of assessing the efficacy of its depression algorithms, MEB-001.
The company said its clinical team proposed the International Neuropsychiatric Interview (MINI) as a diagnostic tool to satisfy the FDA's request whilst minimising the burden of conduct for the validation trial.
The FDA has confirmed that the MINI can be used to support the trial clinician diagnosis.
Managing director Claude Solitario said, "Medibio welcomes the confirmation by the FDA for MEB-001 to be compared to a mental health diagnosis. This will significantly enhance our De Novo application and, depending upon the results of the trial, may present an opportunity to upgrade MEB001's Indication for Use from a screening tool to a screening/diagnostic tool.
"The request by the FDA to add a clinical diagnosis as a primary comparator to MEB-001 will result in the technology being one major step closer to recognition as a diagnostic tool, a mission Medibio has been working towards for many years, and one that would represent a groundbreaking development in the diagnosis, treatment and management of mental health conditions."
