Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration

Author:

Regnier Fred E1,Skates Steven J2,Mesri Mehdi3,Rodriguez Henry3,Težak Živana4,Kondratovich Marina V4,Alterman Michail A5,Levin Joshua D4,Roscoe Donna4,Reilly Eugene4,Callaghan James4,Kelm Kellie4,Brown David6,Philip Reena4,Carr Steven A7,Liebler Daniel C8,Fisher Susan J9,Tempst Paul10,Hiltke Tara3,Kessler Larry G11,Kinsinger Christopher R3,Ransohoff David F12,Mansfield Elizabeth4,Anderson N Leigh13

Affiliation:

1. Department of Chemistry, Purdue University, West Lafayette, IN

2. Dana-Farber/Harvard Cancer Center, Massachusetts General Hospital, Boston, MA

3. Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health, Bethesda, MD

4. Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD

5. Center for Biologics Evaluation and Research, OCTGT/DCGT/TVBB, Bethesda, MD

6. Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD

7. Broad Institute of MIT and Harvard, Cambridge, MA

8. Jim Ayers Institute for Precancer Detection and Diagnosis, Vanderbilt University Medical Center, Nashville, TN

9. Biomolecular Center and Mass Spectrometry Center, University of California, San Francisco, San Francisco, CA

10. Protein Center, Memorial Sloan-Kettering Cancer Center, New York, NY

11. School of Public Health and Community Medicine, University of Washington, Seattle, WA

12. University of North Carolina at Chapel Hill, Chapel Hill, NC

13. Plasma Proteome Institute, Washington, DC

Abstract

Abstract As a part of ongoing efforts of the NCI-FDA Interagency Oncology Task Force subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the National Cancer Institute have submitted 2 protein-based multiplex assay descriptions to the Office of In Vitro Diagnostic Device Evaluation and Safety, US Food and Drug Administration. The objective was to evaluate the analytical measurement criteria and studies needed to validate protein-based multiplex assays. Each submission described a different protein-based platform: a multiplex immunoaffinity mass spectrometry platform for protein quantification, and an immunological array platform quantifying glycoprotein isoforms. Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays.

Funder

National Cancer Institute

NIH

Publisher

Oxford University Press (OUP)

Subject

Biochemistry, medical,Clinical Biochemistry

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