Genetic Test Law and Legal Definition

Genetic test is the procedure of examining the genes of a patient, which includes analysis of human DNA, RNA, chromosomes, proteins or metabolites in order to analyze the cause of a hereditary disease, genotypes, mutations or chromosomal changes. Genetic test does not include any other medical examinations that do not look for human genetic material. Drug and alcohol tests do not come under the definition of genetic test. Genetic test is also called as DNA based test and it is the latest and most sophisticated techniques used for testing genetic disorders.

According to 42 USCS § 300gg-91 (d) (17) (A) genetic test means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.

The term genetic test does not mean:

(i) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes; or

(ii) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved [42 USCS § 300gg-91 (d)(17)(B)].