Genetic test
Genetic test means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if the analysis detects genotypes, mutations, or chromosomal changes. Genetic test does not include an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition.
Source
45 CFR § 160.103
Scoping language
Except as otherwise provided, the following definitions apply to this subchapter: