Regulatory considerations for companion diagnostic devices

Biomarkers in Medicine

Volumn 9, Issue 1, 2015, Pages 67-75

  Lee, Eunice Y ^a   Shen, Hsin Chieh Jennifer ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Assay; biomarker; codevelopment; in vitro companion diagnostic; medical device; personalized medicine; precision medicine; regulation

Indexed keywords

AFATINIB; BIOLOGICAL MARKER; CETUXIMAB; CRIZOTINIB; DABRAFENIB; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; IMATINIB; PANITUMUMAB; PERTUZUMAB; TRAMETINIB; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; VEMURAFENIB;

ACCURACY; BREAST CANCER; CLINICAL EFFECTIVENESS; COLORECTAL CANCER; COMPANION DIAGNOSTIC; DEVICE APPROVAL; DIAGNOSTIC EQUIPMENT; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL STROMAL TUMOR; HIGH THROUGHPUT SCREENING; HUMAN; IMMUNOHISTOCHEMISTRY; IMMUNOLOGY TEST KIT; IN SITU HYBRIDIZATION; MARKETING; MELANOMA; NON SMALL CELL LUNG CANCER; PERSONALIZED MEDICINE; PROTEIN EXPRESSION; RELIABILITY; REVIEW; SENSITIVITY AND SPECIFICITY; STOMACH CANCER; UNITED STATES; VALIDITY; DEVICES; DIAGNOSTIC TEST; GOVERNMENT REGULATION; NEOPLASMS; PROCEDURES;

BIOLOGICAL MARKERS; DIAGNOSTIC TESTS, ROUTINE; GOVERNMENT REGULATION; HUMANS; INDIVIDUALIZED MEDICINE; NEOPLASMS;

EID: 84921696495     PISSN: 17520363     EISSN: 17520371     Source Type: Journal    
DOI: 10.2217/bmm.14.98     Document Type: Review

References (33)

1. US FDA. Paving the Way for Personalized Medicine. www.fda.gov
2. US FDA. Guidance for Industry and Food and Drug Administration Staff-Companion Diagnostic Devices (2014). www.fda.gov
3. US FDA. Drugs@FDA-FDA Approved Drug Products. www.accessdata.fda.gov
4. US FDA. Premarket Approval (PMA)-Dako HercepTest. www.accessdata.fda.gov
5. Lesko LJ, Salerno RA. Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal, Pharmacogenomics 5(1), 25-30 (2004).
6. Lesko LJ, Salerno RA, Spear BB et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe workshop, J. Clin. Parmacol. 43(4), 342-358 (2003).
7. US FDA. Drug-Diagnostic Co-Development Concept Paper (2005). www.fda.gov
8. US FDA. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). www.fda.gov/companiondiagnostics
9. US FDA. Classify Your Medical Device. www.fda.gov
10. US FDA. Regulatory Controls. www.fda.gov
11. US FDA. Federal Food, Drug, and Cosmetic Act (FD&C Act). www.fda.gov
12. US FDA. De Novo Classification Request for Ferriscan R2-MRI Analysis System Decision Summary. www.accessdata.fda.gov/cdrh-docs/reviews/K124065.pdf
13. US FDA. Part 892 Subpart B-Diagnostic Devices. www.gpo.gov
14. US FDA. Types of Applications. www.fda.gov
15. US FDA. Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review. http://www.fda.gov
16. US FDA. Guidance for Industry and Food and Drug Administration Staff-Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (2014). www.fda.gov
17. US FDA. Medical Device User Fee Amendments 2012 (MDUFA III). www.fda.gov
18. Code of Federal Regulations, Part 814-Premarket Approval of Medical Devices. www.accessdata.fda.gov
19. US FDA. Guidance for Industry and FDA Staff-Premarket Approval Application Modular Review. www.fda.gov
20. Code of Federal Regulations, Part 820-Quality System Regulation. www.accessdata.fda.gov
21. US FDA. Bioresearch Monitoring Program (BIMO). www.fda.gov
22. Code of Federal Regulations, Part 812-Investigational Device Exemptions. www.accessdata.fda.gov
23. US FDA. Labeling Information for Vectibix (Panitumumab). www.accessdata.fda.gov
24. Douillard JY, Siena S, Cassidy J et al. Final results from PRIME: randomized Phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann. Oncol. 25(7), 1346-1355 (2014).
25. MacArthur DG, Manolio TA, Dimmock DP et al. Guidelines for investigating causality of sequence variants in human disease. Nature 508(7497), 469-476 (2014).
26. Biesecker LG, Green RC. Diagnostic clinical genome and exome sequencing. N. Engl. J. Med. 370(25), 2418-2425 (2014).
27. Wiita AP, Schrijver I. Clinical application of high throughput molecular screening techniques for pharmacogenomics. Pharmgenomics Pers. Med. 4, 109-121 (2011).
28. American Association for Cancer Research. Molecularly Informed Clinical Trials (2013). http://cancerprogressreport.org
29. Woodcock J, Griffin JP, Behrman RE. Development of novel combination therapies, N. Engl. J. Med. 364, 985-987 (2011).
30. US FDA. 510(k) Substantial Equivalence Determination Decision Summary (k132750). www.accessdata.fda.gov/cdrh-docs/reviews/K132750.pdf
31. US FDA. Evaluation of Automatic Class III Designation for MiSeqDx Platform Decision Summary (k123989). www.accessdata.fda.gov/cdrh-docs/reviews/K123989.pdf
32. US FDA. Evaluation of Automatic Class III Designation for MqSeqDx Universal Kit 1.0 Decision Summary (k133136). www.accessdata.fda.gov/cdrh-docs/reviews/K133136.pdf
33. US FDA. 510(k) Substantial Equivalence Determination Decision Summary (k124006). www.accessdata.fda.gov/cdrh-docs/reviews/K124006.pdf