Science & Validation
Laboratory-stage evidence supporting the transition toward structured clinical validation and IVDR-aligned development.
298
Laboratory datasets evaluated
90–94%
Sensitivity range
85–89%
Specificity range
7
Cancer areas evaluated
The Unibioscience prototype has completed laboratory-stage proof-of-concept validation under controlled conditions. The study supports technical feasibility and preliminary analytical performance. It does not replace prospective clinical validation, which remains required before regulatory approval or commercial use.
Cancer Areas Evaluated
Colorectal
Liver
Prostate
Thyroid
Ovarian
Breast
Pancreatic
Regulatory Development Path
Our development path aligns with the IVDR framework, progressing from laboratory validation to prospective clinical studies.
TRL 4
Laboratory validation evidence established
TRL 5
Prototype refinement and relevant-environment validation preparation
TRL 6
Prospective clinical validation in preparation
IVDR Pathway
Performance evaluation plan, analytical performance, clinical performance, risk management file, QMS and technical documentation
Need Deeper Technical Detail?
Detailed validation methodology, raw data structure, risk analysis, regulatory gap analysis and performance documentation are available through controlled technical access.