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Literature DB >> 26014592

The FDA and genomic tests--getting regulation right.

Barbara J Evans¹, Wylie Burke, Gail P Jarvik.

Abstract

Entities: Chemical Disease Gene Species

Mesh：

Year: 2015 PMID： 26014592 PMCID： PMC4464691 DOI： 10.1056/NEJMsr1501194

Source DB: PubMed Journal: N Engl J Med ISSN： 0028-4793 Impact factor: 91.245

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10 in total

1. Genetic testing and FDA regulation: overregulation threatens the emergence of genomic medicine.

Authors: James P Evans; Michael S Watson
Journal: JAMA Date: 2015-02-17 Impact factor: 56.272

2. FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science.

Authors: Joshua Sharfstein
Journal: JAMA Date: 2015-02-17 Impact factor: 56.272

3. A new initiative on precision medicine.

Authors: Francis S Collins; Harold Varmus
Journal: N Engl J Med Date: 2015-01-30 Impact factor: 91.245

4. Development of the clinical next-generation sequencing industry in a shifting policy climate.

Authors: Margaret A Curnutte; Karen L Frumovitz; Juli M Bollinger; Amy L McGuire; David J Kaufman
Journal: Nat Biotechnol Date: 2014-10 Impact factor: 54.908

5. CLIA program and HIPAA privacy rule; patients' access to test reports. Final rule.

Authors:
Journal: Fed Regist Date: 2014-02-06

6. Actionable, pathogenic incidental findings in 1,000 participants' exomes.

Authors: Michael O Dorschner; Laura M Amendola; Emily H Turner; Peggy D Robertson; Brian H Shirts; Carlos J Gallego; Robin L Bennett; Kelly L Jones; Mari J Tokita; James T Bennett; Jerry H Kim; Elisabeth A Rosenthal; Daniel S Kim; Holly K Tabor; Michael J Bamshad; Arno G Motulsky; C Ronald Scott; Colin C Pritchard; Tom Walsh; Wylie Burke; Wendy H Raskind; Peter Byers; Fuki M Hisama; Deborah A Nickerson; Gail P Jarvik
Journal: Am J Hum Genet Date: 2013-09-19 Impact factor: 11.025

7. Clinical interpretation and implications of whole-genome sequencing.

Authors: Frederick E Dewey; Megan E Grove; Cuiping Pan; Benjamin A Goldstein; Jonathan A Bernstein; Hassan Chaib; Jason D Merker; Rachel L Goldfeder; Gregory M Enns; Sean P David; Neda Pakdaman; Kelly E Ormond; Colleen Caleshu; Kerry Kingham; Teri E Klein; Michelle Whirl-Carrillo; Kenneth Sakamoto; Matthew T Wheeler; Atul J Butte; James M Ford; Linda Boxer; John P A Ioannidis; Alan C Yeung; Russ B Altman; Themistocles L Assimes; Michael Snyder; Euan A Ashley; Thomas Quertermous
Journal: JAMA Date: 2014-03-12 Impact factor: 56.272

8. Taxonomizing, sizing, and overcoming the incidentalome.

Authors: Isaac S Kohane; Michael Hsing; Sek Won Kong
Journal: Genet Med Date: 2012-02-09 Impact factor: 8.822

9. Large numbers of individuals are required to classify and define risk for rare variants in known cancer risk genes.

Authors: Brian H Shirts; Angela Jacobson; Gail P Jarvik; Brian L Browning
Journal: Genet Med Date: 2013-12-19 Impact factor: 8.822

10. ACMG clinical laboratory standards for next-generation sequencing.

Authors: Heidi L Rehm; Sherri J Bale; Pinar Bayrak-Toydemir; Jonathan S Berg; Kerry K Brown; Joshua L Deignan; Michael J Friez; Birgit H Funke; Madhuri R Hegde; Elaine Lyon
Journal: Genet Med Date: 2013-07-25 Impact factor: 8.822

10 in total

31 in total

1. Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science.

Authors: Barbara J Evans
Journal: Am J Law Med Date: 2016-11

2. Integrating next-generation sequencing into pediatric oncology practice: An assessment of physician confidence and understanding of clinical genomics.

Authors: Liza-Marie Johnson; Jessica M Valdez; Emily A Quinn; April D Sykes; Rose B McGee; Regina Nuccio; Stacy J Hines-Dowell; Justin N Baker; Chimene Kesserwan; Kim E Nichols; Belinda N Mandrell
Journal: Cancer Date: 2017-02-13 Impact factor: 6.860

3. Clinical Application of Targeted Deep Sequencing in Solid-Cancer Patients and Utility for Biomarker-Selected Clinical Trials.

Authors: Seung Tae Kim; Kyoung-Mee Kim; Nayoung K D Kim; Joon Oh Park; Soomin Ahn; Jae-Won Yun; Kyu-Tae Kim; Se Hoon Park; Peter J Park; Hee Cheol Kim; Tae Sung Sohn; Dong Il Choi; Jong Ho Cho; Jin Seok Heo; Wooil Kwon; Hyuk Lee; Byung-Hoon Min; Sung No Hong; Young Suk Park; Ho Yeong Lim; Won Ki Kang; Woong-Yang Park; Jeeyun Lee
Journal: Oncologist Date: 2017-07-12

Review 4. Precision reproductive medicine: multigene panel testing for infertility risk assessment.

Authors: Stephen C Collins
Journal: J Assist Reprod Genet Date: 2017-05-03 Impact factor: 3.412

5. Payer Coverage for Hereditary Cancer Panels: Barriers, Opportunities, and Implications for the Precision Medicine Initiative.

Authors: Julia R Trosman; Christine B Weldon; Michael P Douglas; Allison W Kurian; R Kate Kelley; Patricia A Deverka; Kathryn A Phillips
Journal: J Natl Compr Canc Netw Date: 2017-02-10 Impact factor: 11.908

6. A framework to rank genomic alterations as targets for cancer precision medicine: the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT).

Authors: J Mateo; D Chakravarty; R Dienstmann; S Jezdic; A Gonzalez-Perez; N Lopez-Bigas; C K Y Ng; P L Bedard; G Tortora; J-Y Douillard; E M Van Allen; N Schultz; C Swanton; F André; L Pusztai
Journal: Ann Oncol Date: 2018-09-01 Impact factor: 32.976

7. Performance of ACMG-AMP Variant-Interpretation Guidelines among Nine Laboratories in the Clinical Sequencing Exploratory Research Consortium.

Authors: Laura M Amendola; Gail P Jarvik; Michael C Leo; Heather M McLaughlin; Yassmine Akkari; Michelle D Amaral; Jonathan S Berg; Sawona Biswas; Kevin M Bowling; Laura K Conlin; Greg M Cooper; Michael O Dorschner; Matthew C Dulik; Arezou A Ghazani; Rajarshi Ghosh; Robert C Green; Ragan Hart; Carrie Horton; Jennifer J Johnston; Matthew S Lebo; Aleksandar Milosavljevic; Jeffrey Ou; Christine M Pak; Ronak Y Patel; Sumit Punj; Carolyn Sue Richards; Joseph Salama; Natasha T Strande; Yaping Yang; Sharon E Plon; Leslie G Biesecker; Heidi L Rehm
Journal: Am J Hum Genet Date: 2016-05-12 Impact factor: 11.025

8. Developing context-specific next-generation sequencing policy.

Authors: Margaret Ann Curnutte; Karen L Frumovitz; Juli M Bollinger; Robert M Cook-Deegan; Amy L McGuire; Mary A Majumder
Journal: Nat Biotechnol Date: 2016-05-06 Impact factor: 54.908

9. Power to the People: Data Citizens in the Age of Precision Medicine.

Authors: Barbara J Evans
Journal: Vanderbilt J Entertain Technol Law Date: 2017

10. Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine.

Authors: Robert C Green; Katrina A B Goddard; Gail P Jarvik; Laura M Amendola; Paul S Appelbaum; Jonathan S Berg; Barbara A Bernhardt; Leslie G Biesecker; Sawona Biswas; Carrie L Blout; Kevin M Bowling; Kyle B Brothers; Wylie Burke; Charlisse F Caga-Anan; Arul M Chinnaiyan; Wendy K Chung; Ellen W Clayton; Gregory M Cooper; Kelly East; James P Evans; Stephanie M Fullerton; Levi A Garraway; Jeremy R Garrett; Stacy W Gray; Gail E Henderson; Lucia A Hindorff; Ingrid A Holm; Michelle Huckaby Lewis; Carolyn M Hutter; Pasi A Janne; Steven Joffe; David Kaufman; Bartha M Knoppers; Barbara A Koenig; Ian D Krantz; Teri A Manolio; Laurence McCullough; Jean McEwen; Amy McGuire; Donna Muzny; Richard M Myers; Deborah A Nickerson; Jeffrey Ou; Donald W Parsons; Gloria M Petersen; Sharon E Plon; Heidi L Rehm; J Scott Roberts; Dan Robinson; Joseph S Salama; Sarah Scollon; Richard R Sharp; Brian Shirts; Nancy B Spinner; Holly K Tabor; Peter Tarczy-Hornoch; David L Veenstra; Nikhil Wagle; Karen Weck; Benjamin S Wilfond; Kirk Wilhelmsen; Susan M Wolf; Julia Wynn; Joon-Ho Yu
Journal: Am J Hum Genet Date: 2016-05-12 Impact factor: 11.025