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 specified conditions are met: it is a defined computer-based problem-solving operation; the reported result is the calculated output (not an intermediary); the result cannot be obtained without the process; inputs derive from the submitted biological sample; and the process is either required for the analytical result or, if post-analytical, is independently reasonable and necessary. Routine intermediary computations (eg, NGS variant calling), calculations using only clinical data, or post-processing computations not shown to be independently reasonable and necessary are not considered algorithmic components for coding or valuation.

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