Preclinical Evidence

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Scientific Validity: All in-vitro diagnostic medical devices are based on an analyte used to identify a clinical condition/physiological state; the aim of the scientific validity study is to establish the association of an analyte with a clinical condition/physiological state. If the association is well known for an analyte, determination of scientific validity is not necessary. On the other hand, scientific validity must be demonstrated for a new analyte and/or new intended use.

Analytical Validity: Analytical validity is an indicator of how well a test detects or measures a biomarker (e.g. chemical compound, hormone, genetic marker, etc.) in a sample such as blood and tissue. There are three main characteristics of analytically valid tests: high degree of specificity, preciseness, high measurement capabilities suitable for the intended use, accurateness, and high capability of regularly reproducing the same results, reliability.

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