Built on Laboratory-Stage Validation
The Unibioscience prototype has completed laboratory-stage proof-of-concept validation under controlled conditions. The study supports technical feasibility and preliminary analytical performance.
298
Laboratory datasets evaluated
90–94%
Sensitivity range
85–89%
Specificity range
7
Cancer areas evaluated
Cancer Areas Evaluated
Colorectal
Prostate
Ovarian
Breast
Pancreatic
Liver
Thyroid
Laboratory validation is not final clinical validation. Clinical performance must be confirmed through prospective studies in the intended-use population.
Targeted Cancer Areas Evaluated
The Unibioscience platform is currently in laboratory-stage validation, focusing on the detection of specific biological signals associated with the following cancer types.
Colorectal Cancer
Monitoring for early-stage colorectal cancer risk signals through specific biomarker immunoassays.
Prostate Cancer
Early risk awareness for prostate cancer via targeted biomarker detection in blood samples.
Ovarian Cancer
Structural risk insights for ovarian cancer based on early biological changes.
Breast Cancer
Longitudinal monitoring of breast cancer risk signals using AI-supported analysis.
Pancreatic Cancer
Early risk awareness for pancreatic cancer through sensitive biomarker testing.
Liver Cancer
Thyroid Cancer
Identifying early risk signals for liver cancer using structured risk insights.
Monitoring thyroid cancer risk signals in the context of early biological changes.
Laboratory validation is not final clinical validation. Clinical performance must be confirmed through prospective studies in the intended-use population.
Regulatory Development Path & IVDR Alignment
The Unibioscience platform is progressing through a structured clinical development pathway, aligning with the European IVDR framework to ensure high-fidelity performance and clinical safety.
TRL 4: Laboratory Validation Evidence
- Completed laboratory-stage proof-of-concept validation using 298 datasets.
- Established analytical performance and biomarker signal detectability.
- Technical feasibility confirmed under controlled conditions.
TRL 5: Prototype Refinement
- Refinement of the AI risk engine and smartphone interpretation workflow.
- Preparation for relevant-environment validation in real-world settings.
- Optimization of device normalization algorithms for diverse user environments.
TRL 6: Prospective Clinical Validation
- Transitioning from laboratory to prospective clinical studies.
- Validation in the intended-use population for clinical performance.
- Ensuring safety and efficacy in a clinical setting.
IVDR Pathway: Documentation & Compliance
- Development of the Performance Evaluation Plan (PEP).
- Finalization of the Analytical Performance and Clinical Performance.
- Preparation of the Risk Management File (RMF).
- Implementation of the ISO 13485 Quality Management System (QMS).
- Technical documentation and software validation for AI components.
Important Disclaimer: The Unibioscience platform is currently in clinical development and is not approved for commercial use. It is intended to support early risk awareness and does not provide a definitive diagnosis. Any elevated-risk result should be confirmed through clinical evaluation and laboratory-based testing.
What Comes Next
The Unibioscience platform is transitioning from laboratory-stage validation toward structured clinical validation and full regulatory alignment.
Prospective Clinical Validation
Transitioning from laboratory proof-of-concept to prospective clinical studies in the intended-use population to confirm analytical and clinical performance.
ISO 13485 Quality Management System
Implementation of a comprehensive quality management system to ensure consistent manufacturing, testing, and data integrity across all production batches.
IVDR Technical Documentation
Development of a full IVDR-aligned technical documentation package, including Performance Evaluation Plans and Risk Management Files.
Software and AI Validation
Comprehensive validation of the AI risk engine and digital intelligence layer to ensure safety, security, and accuracy of longitudinal risk insights.
Usability and Human Factors
Ensuring the platform meets clinical usability standards through rigorous human factors testing and user experience optimization.
Manufacturing and Lot-to-Lot Validation
Finalizing manufacturing processes and conducting lot-to-lot consistency testing to support a scalable, high-quality production pipeline.
Need Deeper Technical Detail?
Detailed validation methodology, raw data structure, risk analysis, regulatory gap analysis and performance documentation are available through controlled technical access.
Access is restricted to qualified scientific reviewers, institutional partners and investors. All data is subject to strict confidentiality agreements.