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 conditions are met: it is a computer-based unambiguous calculation whose output is the test result (not an intermediary), uses inputs derived from the submitted biological sample, and is necessary for the result or independently reasonable and necessary if post-analytical. Computation that is merely intermediary (e.g., NGS variant calling), uses only clinical data, lacks sample-derived input, or is not independently justified does not qualify as an algorithm component.

"The algorithm is an unambiguous problem-solving operation that deploys a set of rules or calculations requiring computer processing."

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