Risks of presymptomatic direct-to-consumer genetic testing

New England Journal of Medicine

Volumn 363, Issue 12, 2010, Pages 1100-1101

  Annes, Justin P ^a,b   Giovanni, Monica A ^a   Murray, Michael F ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b Harvard University   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER HEALTH INFORMATION; DNA DETERMINATION; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; HEALTH CARE DELIVERY; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HUMAN; PATIENT SAFETY; PRIORITY JOURNAL; RISK FACTOR; SHORT SURVEY; DEVICE APPROVAL; GENETIC PREDISPOSITION; GENETICS; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; STANDARDS; UNITED STATES;

UNSPECIFIC MONOOXYGENASE;

ARYL HYDROCARBON HYDROXYLASES; DEVICE APPROVAL; GENETIC PREDISPOSITION TO DISEASE; GENETIC TESTING; GOVERNMENT REGULATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77956671195     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1006029     Document Type: Short Survey

References (5)

1. Food and Drug Administration. Medical devices. Letters to industry. (Accessed August 2, 2010, at http://www.fda.gov/MedicalDevices/ResourcesforYou/ Industry/ucm111104.htm.)
2. Holtzman NA. Promoting safe and effective genetic tests in the United States: work of the task force on genetic testing. Clin Chem 1999;45(5):732-8. (Also available at http://www.genome.gov/10001733.)
3. Food and Drug Administration. Medical devices. Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System - K042259. (Accessed August 2, 2010, at http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently- ApprovedDevices/ucm078879.htm.)
4. Wilson JMG, Jungner G. Principles and practice of screening for disease. WHO Chron 1968;22:473-83.
5. Andermann A, Blancquaert I, Beauchamp S, Déry V. Revisiting Wilson and Jungner in the genomic age: a review of screening criteria over the past 40 years. Bull World Health Organ 2008;86:317-9. (Pubitemid 351521860)