Analytical validation of protein-based multiplex assays: A workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics

Clinical Chemistry

Volumn 56, Issue 2, 2010, Pages 237-243

  Rodriguez, Henry ^a   Težak, Živana ^a   Mesri, Mehdi ^a   Carr, Steven A ^a   Liebler, Daniel C ^a   Fisher, Susan J ^a   Tempst, Paul ^a   Hiltke, Tara ^a   Kessler, Larry G ^a   Kinsinger, Christopher R ^a   Philip, Reena ^a   Ransohoff, David F ^a   Skates, Steven J ^a   Regnier, Fred E ^a   Leigh Anderson, N ^a   Mansfield, Elizabeth ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

TUMOR MARKER;

ASSAY; CANCER DIAGNOSIS; CLINICAL ASSESSMENT; DIAGNOSTIC PROCEDURE; FOOD AND DRUG ADMINISTRATION; MASS SPECTROMETRY; MICROARRAY ANALYSIS; PROTEOMICS; REVIEW; RISK ASSESSMENT;

HUMANS; MASS SPECTROMETRY; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; PROTEOMICS; TUMOR MARKERS, BIOLOGICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VALIDATION STUDIES AS TOPIC;

EID: 75749119372     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2009.136416     Document Type: Review

References (7)

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2. FDA. Sec. 513. [21 USC §360c]. Classification of devices intended for human use; device classes. http://www.fda.gov/RegulatoryInformation/ Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCAct ChapterVDrugsandDevices/ ucm110188.htm (Accessed January 2010). See (a)(1) section.
3. FDA. Chapter I - Food and Drug Administration, Department of Health and Human Services. Subchapter H - Medical devices. Part 860 - Medical device classification procedures. Subpart A - General. Sec. 860.7 Determination of safety and effectiveness. In: FDA. CFR - Code of Federal Regulations Title 21. Title 21 - Food and drugs. Vol. 8. http:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfCFR/CFRSearch.cfm? FR860.7 (Accessed January 2010).
4. FDA. 510(k) Substantial equivalence determination decision summary. http://www.accessdata.fda.gov/cdrh-docs/reviews/K080252.pdf (Accessed January 2010). Summary for MammaPrint.
5. FDA. Chapter I - Food and Drug Administration, Department of Health and Human Services. Subchapter H - Medical devices. Part 820 - Quality system regulation. In: FDA. CFR - Code of Federal Regulations Title 21. Title 21 - Food and drugs. Vol. 8. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=820&showFR =1 (Accessed January 2010).
6. Addona T, Abbatiello SE, Skates SJ, Bunk DM, Schilling B, Spiegelman CH, et al., CPTAC Network. Multi-site assessment of the precision and reproducibility of multiple reaction monitoring-based measurements of proteins in plasma. Nat Biotechnol 2009;27:633-44.
7. Regnier FE, Skates SJ, Mesri M, Rodriguez H, Težak Ž, Kondratovich MV, et al. Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration. Clin Chem 2010; 56:165-71.