Module 18 2021

06/02/2021

– demonstrate the following in accordance with Intended Use Statement:

Scientific Validity Analytical Performance

Clinical Performance

The association of an analyte to a clinical condition or a physiological state

The ability of a device to correctly detect or measure a particular analyte

The ability of a device to yield results that are correlated with a particular clinical condition or a pathological

process or state in accordance with the target population and intended user

Performance Indicators for IVDs

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Companion Diagnostics clinical performance studies

CDx CPSs can be pro- or retro-spective, normally conducted at an accredited central laboratory. Prospective studies involve testing clinical samples collected during a clinical trial Retrospective studies involve testing clinical samples collected from patients for research purposes

The route to an approved CDx is a simultaneous one between Pharma sponsor and Diagnostic sponsor

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