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 whose output is the final test result, is required to obtain that result, and uses inputs derived from the submitted biological sample. Computational steps that are intermediary to analytical processes, use only clinical (non-sample) data, or are post-analytical but not independently reasonable and necessary are not considered algorithms under this policy.

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

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