Genetic Testing

The Genetic Testing categories are for laboratories performing procedures for the purpose of providing information for the diagnosis of a genetic disease or its carrier state or risk assessment for drug metabolism and/or hemostasis. Predisposition testing for inherited cancers; tests using genetic markers to monitor disease progression, therapeutic response, preimplantation diagnosis; and pharmacogenetics applications are all included in the Genetic Testing category. In addition, this category includes the use of genetic markers to test for zygosity for pregnancy management and maternal cell contamination in the context of genetic diagnosis. Some applications of these methodologies are excluded from approval in the genetic testing category, such as paternity testing, forensic testing, somatic changes in tumor tissue (molecular oncology) and tissue typing services.