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Genomics|Features|Oversight of Genomic Medicine

Oversight of Genomic Medicine

Oversight of Genomic Tests - July 8, 2015

Regulatory changes raise troubling questions for genomic testing.
Evans BJ et al. Genet. Med. 2014 Nov 16(11) 799-803

FDA's draft guidance on laboratory-developed tests increases clinical and economic risk to adoption of pharmacogenetic testing.
Levy KD et al. J Clin Pharmacol 2015 Jul 55(7) 725-7

The FDA and genetic testing.
Litwack ED et al. N. Engl. J. Med. 2015 May 27.

The FDA and genomic tests - getting regulation right
Evans BJ et al, NEJM, May 27, 2015

Public Workshop - Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests, February 20, 2015

Cutting the Gordian Helix - Regulating genomic testing in the era of precision medicine.
Lander Eric S et al. N. Engl. J. Med. 2015 Feb 17.

In NEJM, Lander lauds steps at FDA to build new regulatory framework for genomic tests,Genome Web, Feb 18 [by free subscription only]

Regulatory changes raise troubling questions for genomic testing.
Evans Barbara J et al. Genet. Med. 2014 Nov (11) 799-803

FDA regulation of laboratory-developed diagnostic tests: Protect the public, advance the science.
Sharfstein Joshua et al. JAMA 2015 Feb 17. (7) 667-668

Genetic testing and FDA regulation: Overregulation threatens the emergence of genomic medicine.
Evans James P et al. JAMA 2015 Feb 17. (7) 669-670

FDA outlines plan for expected $10M under President's Precision Medicine Plan, Genome Web, Feb 18 [by free subscription only]

Direct to Consumer Genetic Tests: Recent Oversight Developments - February 24, 2015

The shifting sands of direct-to-consumer genetic test regulation, by Philippa Brice, PHG Foundation, Feb 23

FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome FDA Press Release, Feb 19

FDA. eases access to DNA tests of rare disorders  by Andrew Pollack, New York Times, Feb 19

FDA approves marketing of 23andMe's carrier test for Bloom syndrome and Bloom syndrome only.by Cecile Janssens, A. Cecile J.W. Janssens Blog, Feb 20

FDA eases access to DNA screening for inherited diseases  by Mathew Perone, Big Story, Feb 19

FDA clearance of DTC genetic test gets mixed reviews by Ricki Lewis, Medscape Medical News, Feb 20

US regulators try to tame 'wild west' of DNA testing
Experts, regulators mull how to foster technologies without posing undue risk to patients. Erika Check Hayden, Nature News, February 20, 2015

Association for Molecular Pathology Position Statement:
Direct Access Genetic Testing (Direct to Consumer Genetic Testing),  [PDF 119.84 KB] February 2015

NCI paper: Public awareness of direct-to-consumer genetic tests: Findings from the 2013 U.S. Health Information National Trends Survey.
Agurs-Col lins T et al. J Cancer Educ. 2015 Jan 20.

A new approach to assessing affect and the emotional implications of personal genomic testing for common disease risk.
O'Neill SC, et al. Public Health Genomics. 2015 Jan 21.

Design, methods, and participant characteristics of the Impact of Personal Genomics (PGen) Study, a prospective cohort study of direct-to-consumer personal genomic testing customers.
Carere DA, et al. Genome Med. 2014 Dec 3;6(12):96

Ethical considerations regarding classroom use of personal genomic information.
Parker LS, Grubs R. J Microbiol Biol Educ. 2014 Dec 15;15(2):191-6.

Personal genomes, participatory genomics and the anonymity-privacy conundrum.
Scaria V. J Genet. 2014 Dec;93(3):917-20

Direct to consumer genetic testing—is all knowledge power? By Margaret McCartney, BMJ 2015; 350,  26 January 2015

Who should have access to your DNA? By Eric Topol, the Medium, Jan 22