Literature DB >> 25965745

Precision medicine and the FDA's draft guidance on laboratory-developed tests.

Thomas J Hwang1, Lisa Soleymani Lehmann2, Aaron S Kesselheim3.   

Abstract

Mesh:

Year:  2015        PMID: 25965745     DOI: 10.1038/nbt.3221

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN: 1087-0156            Impact factor:   54.908


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  7 in total

1.  American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer.

Authors:  Debbie Saslow; Diane Solomon; Herschel W Lawson; Maureen Killackey; Shalini L Kulasingam; Joanna Cain; Francisco A R Garcia; Ann T Moriarty; Alan G Waxman; David C Wilbur; Nicolas Wentzensen; Levi S Downs; Mark Spitzer; Anna-Barbara Moscicki; Eduardo L Franco; Mark H Stoler; Mark Schiffman; Philip E Castle; Evan R Myers
Journal:  Am J Clin Pathol       Date:  2012-04       Impact factor: 2.493

2.  Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer.

Authors:  Eunice L Kwak; Yung-Jue Bang; D Ross Camidge; Alice T Shaw; Benjamin Solomon; Robert G Maki; Sai-Hong I Ou; Bruce J Dezube; Pasi A Jänne; Daniel B Costa; Marileila Varella-Garcia; Woo-Ho Kim; Thomas J Lynch; Panos Fidias; Hannah Stubbs; Jeffrey A Engelman; Lecia V Sequist; WeiWei Tan; Leena Gandhi; Mari Mino-Kenudson; Greg C Wei; S Martin Shreeve; Mark J Ratain; Jeffrey Settleman; James G Christensen; Daniel A Haber; Keith Wilner; Ravi Salgia; Geoffrey I Shapiro; Jeffrey W Clark; A John Iafrate
Journal:  N Engl J Med       Date:  2010-10-28       Impact factor: 91.245

3.  Cancer: Missing the mark.

Authors:  Lizzie Buchen
Journal:  Nature       Date:  2011-03-24       Impact factor: 49.962

4.  FDA pushes for control over laboratory-developed tests.

Authors:  Mark Ratner
Journal:  Nat Biotechnol       Date:  2014-09       Impact factor: 54.908

5.  Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.

Authors:  Thomas J Hwang; Jerry Avorn; Daniel Carpenter; Aaron S Kesselheim
Journal:  Health Aff (Millwood)       Date:  2014-02       Impact factor: 6.301

6.  Multitarget stool DNA testing for colorectal-cancer screening.

Authors:  Thomas F Imperiale; David F Ransohoff; Steven H Itzkowitz; Theodore R Levin; Philip Lavin; Graham P Lidgard; David A Ahlquist; Barry M Berger
Journal:  N Engl J Med       Date:  2014-03-19       Impact factor: 91.245

7.  Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnosis of Lyme disease.

Authors:  Christina Nelson; Sally Hojvat; Barbara Johnson; Jeannine Petersen; Marty Schriefer; C Ben Beard; Lyle Petersen; Paul Mead
Journal:  MMWR Morb Mortal Wkly Rep       Date:  2014-04-18       Impact factor: 17.586

  7 in total
  3 in total

Review 1.  Stool DNA methylation assays in colorectal cancer screening.

Authors:  Tanya Kadiyska; Alexander Nossikoff
Journal:  World J Gastroenterol       Date:  2015-09-21       Impact factor: 5.742

2.  Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing.

Authors:  Annette S Kim; Angela N Bartley; Julia A Bridge; Suzanne Kamel-Reid; Alexander J Lazar; Neal I Lindeman; Thomas A Long; Jason D Merker; Alex J Rai; David L Rimm; Paul G Rothberg; Patricia Vasalos; Joel T Moncur
Journal:  JAMA Oncol       Date:  2018-06-01       Impact factor: 31.777

3.  Crosstalk between DNA methylation and gene expression in colorectal cancer, a potential plasma biomarker for tracing this tumor.

Authors:  Mohammad Amin Kerachian; Ali Javadmanesh; Marjan Azghandi; Afsaneh Mojtabanezhad Shariatpanahi; Maryam Yassi; Ehsan Shams Davodly; Amin Talebi; Fatemeh Khadangi; Ghodratollah Soltani; Abdorasool Hayatbakhsh; Kamran Ghaffarzadegan
Journal:  Sci Rep       Date:  2020-02-18       Impact factor: 4.379

  3 in total

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