A Call for Participatory Oversight

Byrne J , Edelson V , Friedland A , Terry SF (2007) Eyes on the Prize: Truthtelling About Genetic Testing. Washington, DC: Genetic Alliance.

FDA (2006a) Draft guidance for industry, clinical laboratories, and FDA Staff: In vitro diagnostic multivariate index assays. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071455.pdf

FDA (2006b) Draft guidances for industry and FDA Staff: commercially distributed analyte specific reagents. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071269.pdf

Horn EJ , Terry SF (2012) Regulating genetic tests: issues that guide policy decisions. Genet Test Mol Biomarkers, 16, 1-2.

Hudson K (2003) The vagaries of government regulation. Conscience, 24, 18.

Hudson K , Javitt GH (2006a) Personalized medicine: the perfect storm for improving genetic testing quality. Research Policy Alert. Available at: http://www.dnapolicy.org/resources/The_Perfect_Storm.pdf

Hudson K , Javitt G (2006b) FDA Regulation of Genetic Tests. Washington, DC: Genetics and Public Policy Center.

Hudson KL (2006) Genetic testing oversight. Science, 313, 1853.

Hudson K , Lurie P , Terry SF (2006a) Petition requesting a genetic testing specialty and standards for proficiency testing. Genetics and Public Policy Center, Public Citizen's Health Research Group, and Genetic Alliance. Available at: http://www.citizen.org/Page.aspx?pid=622

Hudson KL , Murphy JA , Kaufman DJ , Javitt GH , Katsanis SH , Scott J (2006b) Oversight of US genetic testing laboratories. Nat Biotechnol, 24, 1083-1090.

Javitt GH , Hudson K (2006) Public Health at Risk: Failures in Oversight of Genetic Testing Laboratories. Washington, DC: Genetics and Public Policy Center.

Popeo DJ , Samp RA (2006) Citizen's petition regarding FDA regulation of laboratory developed tests. Available at: http://www.wlf.org/upload/Clinical%20Labs-%20FDA%20Citizen%20Petition.pdf

Secretary's Advisory Committee on Genetics, Health, and Society. 2008. Report, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services. Available at: http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf

Simoncelli T (2013) Paving the way for personalized medicine: FDA's role in a new era of medical product development. Available at: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf

Zonno KD , Terry PF , Terry SF (2009) A measure of truth in genetic testing. Genet Test Mol Biomarkers, 13, 285-286.

Zonno KD , Terry SF (2009a) Registry of genetic tests: a critical stepping stone to improving the genetic testing system. Genet Test Mol Biomarkers, 13, 153-154.

Zonno KD , Terry SF (2009b) Transparency, openness, and genetic testing. Genet Test Mol Biomarkers, 13, 433-434.