American Clinical Laboratory Association. (2013, June 4). Citizens petition to Food & Drug Administration.Google Scholar

American Clinical Laboratory Association. (2014). ACLA retains Attorneys Paul D. Clement and Lawrence H. Tribe to represent ACLA in opposing the FDA’s proposal to treat laboratory developed tests (LDTs) as medical devices. Retrieved from www.acla.com/acla-retains-attorneys-paul-d-clement-and-laurence-h-tribe-to-represent-acla-in-opposing-the-fdas-proposal-to-treat-laboratory-developed-tests-ldts-as-medical-devices/.Google Scholar

Arkansas Code § 6-18-702(d)(4).Google Scholar

Blood Screening of Newborns for Treatable Diseases and Disorders, Code of Massachusetts Regulations Title 105 § 270.006.Google Scholar

Board of Education v. Earls, 536 U.S. 822 (2002).Google Scholar

Boone v. Boozman, 217 F. Supp. 2d 938 (E.D. Ark. 2002).Google Scholar

Centers for Medicare and Medicaid Services. (2013, October 22). LDT and CLIA FAQs. Retrieved from www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/LDT-and-CLIA_FAQs.pdf.Google Scholar

Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a et seq.Google Scholar

College of American Pathologists. (2010, August 15). Comments to the Food and Drug Administration on oversight of laboratory developed tests.Google Scholar

Common Rule Definitions, 45 C.F.R. § 46.102.Google Scholar

Confidentiality of Records of Genetic Tests, New York Civil Rights Law § 79-l.Google Scholar

Douglas County v. Anaya, 694 N.W.2d 601, 608 (Neb. 2005).Google Scholar

E.M. ex rel. E.M. v. Pajaro Valley Unified School District Office of Administrative Hearings, 652 F.3d 999, 1004 (9th Cir. 2011).Google Scholar

Ferguson v. City of Charleston, 532 U.S. 67, 76 n.9 (2001).Google Scholar

Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.Google Scholar

U.S. Department of Health & Human Services. (2017, January 19). Federal Policy for the Protection of Human Subjects (the “Common Rule”) Final Rule. 82 Fed. Reg. 7,149.Google Scholar

Food and Drug Administration. (1997, November 21). Analyte Specific Reagents – Final Rule. 62 Fed. Reg. 62,243, 62,249.Google Scholar

Food and Drug Administration (2007, June 19). Guidance for industry and FDA staff: Pharmacogenetic tests and genetic tests for heritable markers. Retrieved from www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071075.pdf.Google Scholar

Food and Drug Administration. (2010, June 10). Letter to 23andMe. Retrieved from www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf.Google Scholar

Food and Drug Administration. (2014, January 17). FDA allows marketing for first-of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children. Retrieved from www.fda.gov/newsevents/newsroom/pressannouncements/ucm382179.htm.Google Scholar

Food and Drug Administration. (2014, October 3). Draft guidance for industry, Food and Drug Administration staff, and clinical laboratories. Framework for regulatory oversight of laboratory developed tests (LDTs). Retrieved from www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416685.pdf.Google Scholar

Food and Drug Administration. (2010, June 17). Oversight of Laboratory Developed Tests – Public Meeting & Request for Comments. 75 Fed. Reg. 34,463.Google Scholar

Food and Drug Administration. Premarket approval. Retrieved www.fda.gov/Medicaldevices/Deviceregulationandguidance/Howtomarketyourdevice/Premarketsubmissions/Premarketapprovalpma/Default.Htm.Google Scholar

Food and Drug Administration. (2013, November 22). Warning letter to 23andMe. Retrieved from www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm.Google Scholar

Food and Drug Administration. (2017, January 13). Discussion Paper on Laboratory Developed Tests (LDTs). Retrieved from www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LaboratoryDevelopedTests/UCM536965.pdf.Google Scholar

Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112–144, § 1143.Google Scholar

Genetic Information Privacy Act, Illinois Compiled Statutes ch. 410 § 513.Google Scholar

Hamburg, M. (2013, June 2). Commissioner’s address, Annual Meeting of the American Society of Clinical Oncology. Retrieved from www.fda.gov/NewsEvents/Speeches/ucm354888.htm.Google Scholar

Individuals with Disabilities Education Act, 20 U.S.C. § 1400 et seq.Google Scholar

Individuals with Disabilities Education Act Regulations, 34 C.F.R. pt. 300 et seq.Google Scholar

Larry P. by Lucille P. v. Riles, 793 F.2d 969, 976 (9th Cir. 1984).Google Scholar

Lewin, T. (2010, May 18). College bound, DNA swab in hand. New York Times, p. A14. Retrieved from www.nytimes.com/2010/05/19/education/19dna.html?_r=1&.Google Scholar

Massachusetts General Laws ch.76 § 15.Google Scholar

McCarthy v. Boozman, 212 F. Supp. 2d 945 (W.D. Ark. 2002).Google Scholar

Minnesota Statutes § 144.125, subdivision 4.Google Scholar

Nebraska Revised Statutes § 71–519.Google Scholar

Newborn Screening Saves Lives Reauthorization Act of 2014, H.R. 1281.Google Scholar

New Jersey v. T.L.O., 469 U.S. 325, 336–37 (1985).Google Scholar

Pergament, D. (2013, Spring). What does choice really mean? Prenatal testing, disability, and special education without illusions. Health Matrix, 23, 55–117.Google Scholar

Perrone, M. (2014, January 17). FDA approves genetic test that screens infants for predictors of mental disabilities. The Associated Press. Retrieved from www.ctvnews.ca/health/fda-approves-genetic-test-that-screens-infants-for-predictors-of-mental-disabilities-1.1644306#.Uw9UiFoshj8.email.Google Scholar

Sanders, R. (2010, August 12). U.C. Berkeley alters DNA testing program. Retrieved from http://newscenter.berkeley.edu/2010/08/12/dna_change/.Google Scholar

Sanders, R. (2010, September 10). Tempest in a spit cup. Retrieved from http://newscenter.berkeley.edu/2010/09/10/tempest_over_dna_testing/.Google Scholar

Sarata, A., & Johnson, J. (2014, March 27). Regulation of clinical tests: In vitro diagnostic (IVD) devices, laboratory developed tests (LDTs), and genetic tests. Retrieved from www.fas.org/sgp/crs/misc/R43438.pdf.Google Scholar

Shuren, J. (2010, July 22). Statement before the Subcommittee on Oversight and Investigations, U.S. House of Representatives. Retrieved from www.fda.gov/newsevents/testimony/ucm219925.htm.Google Scholar

Schmerber v. State of California, 384 U.S. 757, 767–68 (1996).Google Scholar

Secretary’s Advisory Committee on Genetics, Health & Society. (2008). U.S. system of oversight of genetic testing: A response to the charge of the Secretary of Health and Human Services. Retrieved from http://osp.od.nih.gov/sites/default/files/SACGHS_oversight_report.pdf.Google Scholar

Skinner v. Railway Labor Executives Assn., 489 U.S. 602, 618 (1989).Google Scholar

Slaughter, L. et al. (2013, August 9). Letter to the Honorable Sylvia Mathews Burwell, Director, Office of Management and Budget. Retrieved from www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Gray%20Sheet/39/33/OMB%20Letter%20080913.pdf.Google Scholar

Spiering v. Heineman, 448 F. Supp. 2d 1129 (D. Neb. 2006).Google Scholar

US Constitution, Amendments 1, 4, 14.Google Scholar

US House of Representatives, Report No. 114 – xxx, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2017 (2016, April 19).Google Scholar

Vernonia School District 47J v. Acton, 515 U.S. 646 (1995).Google Scholar