VeraSci, a provider of scientific and biotechnology services, revealed on Thursday that it has received a US Food and Drug Administration (FDA) grant to conduct further research on VRFCAT (Virtual Reality Functional Capacity Assessment Tool), its proprietary functional capacity assessment.
VRFCAT was recently accepted into the FDA's COA Qualification Program as a measure of functional capacity for schizophrenia treatment trials.
The project will use qualitative research methods to establish the clinical meaningfulness of this measure to patients, family members and peer support specialists. This will help to advance VRFCAT through the FDA qualification process.
VRFCAT is an eCOA task that simulates key instrumental activities of daily living in a realistic and interactive virtual environment. The tool, which has demonstrated sensitivity to accepted measures of cognitive and functional deficits in multiple CNS disorders, was developed in the company's Innovation Lab to improve clinical trials by detecting functionally meaningful improvements in patients' everyday lives.
According to the company, VRFCAT has numerous advantages when compared to conventional assessments and meets the highest psychometric standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.
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