Quality, Regulation and Clinical Utility of Laboratory-developed Molecular Tests (AHRQ)

Excerpt: Available through the Agency for Healthcare Research and Quality (AHRQ) Web site. In this report, we use the term "molecular test" (MT) interchangeably with the term "molecular genetic test." We adopted the definition of molecular genetic test recommended by the Genetic Work Group of the Clinical Laboratory Improvement Advisory Committee. The Work Group defined a genetic molecular test as "an analysis performed on human DNA or RNA to detect heritable or acquired disease-related genotypes, mutations, or phenotypes for clinical purposes." According to this definition, cytogenetic tests, which are  performed on human chromosomes, and biochemical genetic tests, which analyze human proteins and ...