FDA perspective on companion diagnostics: An evolving paradigm

Clinical Cancer Research

Volumn 20, Issue 6, 2014, Pages 1453-1457

  Mansfield, Elizabeth A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER DIAGNOSIS; COMPANION DIAGNOSTICS; DIAGNOSTIC EQUIPMENT; DIAGNOSTIC TEST; DIAGNOSTIC TEST APPROVAL; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; MOLECULAR DIAGNOSIS; MOLECULARLY TARGETED THERAPY; NEOPLASMS; STANDARDS; UNITED STATES;

ANTINEOPLASTIC AGENT;

ANTINEOPLASTIC AGENTS; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; MOLECULAR TARGETED THERAPY; NEOPLASMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896537994     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-1954     Document Type: Review

References (6)

1. FDA Guidance for Industry: Pharmacogenomic Data Submissions [homepage on the Internet]. Silver Spring, MD: FDA; 2005. [cited 2013 Oct 31]. Available from: http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126957. pdf.
2. FDADrug-DiagnosticCo-DevelopmentConceptPaper [homepageonthe Internet]. SilverSpring,MD:FDA;2005. [cited2013Oct31].Available from: http://www.fda.gov/ downloads/drugs/scienceresearch/researchareas/pharmacogenetics/ucm116689.pdf.
3. FDA Draft Guidance for Industry and Food and Drug Administration Staff. In Vitro Companion Diagnostic Devices. Silver Spring, MD: FDA; 2011. [cited 2013 Oct 31] Available from: http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf.
4. Byron SK, Crabb N, George E, Marlow M, Newland A. The health technology assessment of companion diagnostics: experience of NICE. Clin Cancer Res 2014;20:1469-76.
5. Pignatti F, Ehmann F, Hemmings R, Jonsson B, Nuebling M, Papaluca-Amati M, et al. Cancer drug development and the evolving regulatory framework for companion diagnostics in the European Union. Clin Cancer Res 2014;20:1458-68.
6. Frampton GM, Fichtenholtz A, Otto GA, Wang K, Downing SR, He J, et al. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nat Biotechnol 2013; 31:1023-31.