Genomics|Features|Oversight of Genomic Medicine

Genomics|Features|Oversight of Genomic Medicine

Oversight of Genomic Medicine

Direct to Consumer Genetic Tests: Recent Oversight Developments - February 20, 2015

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

Oversight of Next Generation Sequencing - February 18, 2015

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