MolDX: Algorithm definition as a component of a laboratory test

An algorithm qualifies as a meaningful, independent laboratory test component only when it is a computer-based, unambiguous problem-solving operation whose calculated output (not an intermediary) is necessary to produce the reported result, and whose inputs derive from the submitted biological specimen. Computation that is merely variant-calling within NGS pipelines, uses only clinical (non-analytical) data, or is post-processing not independently established as reasonable and necessary is not considered an algorithm under this policy.

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

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