Owlstone Medical can facilitate access to a worldwide network of clinical and hospital partners, to validate the biomarkers in patient groups that are representative of the intended use population.
Prior to validation, analysis of candidate VOC biomarkers is performed in a larger patient cohort to verify the performance of the classifier, and further refine the classifier if needed.
Following successful verification of the classifier, an external blinded validation is performed in a larger patient cohort representative of the intended use population.
External blinded test validation
We demonstrate the verified test’s utility against a clinically-relevant, blinded patient population.
The aim of external blinded test validation is to validate both the VOC biomarker algorithm and the analytical instrumentation that together comprise a diagnostic test ready for regulatory approval.
Through Owlstone Medical’s network of clinicians, hospitals and research centres we are able to provide access to large patient populations that reflect the intended use of the biomarkers. Our experts are on hand to provide advice and guidance on the research protocol, securing ethics, sample collection and storage and managing the project to meet your individual requirements.
Our electronic case report forms and patient outcome data are held securely in our cloud-hosted data repository.
To validate the biomarker test all data is blinded to our statisticians who run the test. Once the data has been processed and putative results determined, an independent clinician provides the blinding key only after the test classification is reported, allowing full confidence in the validity and reproducibility of the results.