Challenge: An IVD startup needed scientific validity documentation for a novel biomarker with limited published evidence to support their IVDR Class C submission.

Solution: Our AI tools identified related research across multiple databases, including gray literature, preprints, and conference abstracts, while our scientific team extracted and analyzed all relevant data.Result: Produced a comprehensive scientific validity report that established sufficient theoretical basis for the biomarker, allowing the client to proceed with required clinical evidence generation for their Class C submission.