MolDX: Algorithm definition as a component of a laboratory test

An algorithm is considered a meaningful independent component of a laboratory test only when all specific conditions are met: it is an unambiguous computational problem-solving process using sample-derived analytical data, produces the calculated reported result (not an intermediary), yields results not achievable without it, and is required for the analytical result or is independently reasonable and necessary if post-analytical. Computational steps that are intermediary (e.g., NGS variant calling), that use only clinical (non-sample) data, or that are not independently validated or necessary are not considered valid algorithm components.

"An algorithm is a meaningful independent component when it is an unambiguous problem-solving operation that deploys a set of rules or calculations requiring computer processing."

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