Government
The Secretary’s Advisory Committee for Genetics, Health and Society (SACGHS), a section of the Health and Human Services department, has released a draft report of its investigation of the oversight systems for genetic testing, including its recommendations for improving these systems. The report calls for the development of enforcement methods against labs performing genetic tests for clinical purposes without Clinical Laboratory Improvement Amendments certification or making false or misleading claims about genetic tests. The improvement of organizational “pathways” within the public and private sectors for examining the validity and clinical utility of genetic tests are also recommended. Evidence of genetic tests’ clinical utility is a particular concern, as more public and private healthcare payers are calling for proof of the efficacy of drugs and genetic tests before approving them. Source: SACGHS