title: Analysis: Secretary's Advisory Committee on Genetics, Health, and Society Report falls short.
abstract: On April 30, 2008, the Secretary's Advisory Committee on Genetics, Health, and Society released its Report, "US System of oversight of genetic testing: a response to the charge of the Secretary of HHS." Positive features of this Report include recommendations for increased funding for the development and characterization of reference materials and methods; enhanced support for the growth and improvement of public reference sequence databases; encouragement for the implementation of electronic medical records; promotion of the efforts of clinical utility-oriented study groups such as the Evaluation of Genomic Applications in Practice and Prevention Working Group; and enforcement of the prohibitions against clinical testing by laboratories that lack Clinical Laboratory Improvement Amendments certification. The Committee reaffirmed recommendations set forth in its publication, "Coverage and reimbursement of genetic tests and services," that would expand Medicare coverage and increase payment rates for appropriately performed genetic tests. However, in its Report, the Secretary's Advisory Committee on Genetics, Health, and Society used an overly broad definition of genetic testing that is neither scientifically sound nor practically workable. This definition led to the Committee's inability to distinguish genetic tests from other complex laboratory assays. The Report has fallen short by unnecessarily advocating for Food and Drug Administration review of all laboratory developed tests and proposing the creation of a mandatory registry for all clinical laboratory tests.
authors.affiliation: Department of Oncologic Sciences, Molecular Diagnostics, H. Lee Moffitt Cancer Center and Research Institute, University of South Florida College of Medicine, Hematopathology and Laboratory Medicine, FL 33612, USA. roger0@adelphia.net
authors.forename: Roger D
authors.initials: RD
authors.lastname: Klein
mesh_terms: D026683:Advisory Committees; D019411:Clinical Laboratory Techniques / Q000592:standards*; D005820:Genetic Testing / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D006801:Humans; D011640:Public Policy; D014481:United States; D014483:United States Dept. of Health and Human Services