Changes on the horizon for consumer genomics in the EU: Test results may no longer be available directly to consumers

Science

Volumn 346, Issue 6207, 2014, Pages 296-298

  Kalokairinou, Louiza ^a   Howard, Heidi Carmen ^b   Borry, Pascal ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b UPPSALA UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

AUTHORITARIANISM; EUROPEAN UNION; GENOMICS; MEDICAL GEOGRAPHY; PUBLIC HEALTH;

ALZHEIMER DISEASE; CARDIOVASCULAR DISEASE; CONSUMER; DEVICE APPROVAL; DEVICE SAFETY; DIAGNOSTIC EQUIPMENT; EUROPEAN UNION; GENETIC COUNSELING; GENETIC SCREENING; GENOMICS; HEALTH CARE INDUSTRY; HEALTH CARE PERSONNEL; HUMAN; HYPERLIPOPROTEINEMIA; IN VITRO DIAGNOSTIC; LAW; MARKETING; REVIEW; RISK MANAGEMENT; UNITED STATES; ARTICLE; CLASSIFICATION; CONSUMER ADVOCACY; FOOD AND DRUG ADMINISTRATION; GENETIC PRIVACY; GENETIC SERVICE; LEGAL ASPECT; PRACTICE GUIDELINE; RISK ASSESSMENT;

UNITED STATES;

CONSUMER ADVOCACY; EUROPEAN UNION; GENETIC PRIVACY; GENETIC SERVICES; GENETIC TESTING; GENOMICS; GUIDELINES AS TOPIC; HUMANS; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84908110122     PISSN: 00368075     EISSN: 10959203     Source Type: Journal    
DOI: 10.1126/science.1256396     Document Type: Review

References (15)

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2. In June 2014, it was announced that the FDA would review a premarket 510(k) application for Bloom syndrome submitted by the company. Such an application for a single disorder could be considered much simpler than an application (or many applications) for genome-wide testing, from which results are returned for a multitude of phenotypes.
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10. Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (2008); http://conventions.coe.int/Treaty/en/Treaties/Html/203.htm.
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