Medical Devices

Public Workshop – Proteomics in the Clinic, June 13, 2014

The Food and Drug Administration (FDA) announced a public Workshop entitled: “Proteomics in the Clinic”. The topic discussed was the state of the art and challenges surrounding validation of proteomic methodologies for in vitro diagnostic tests.

Date, Time and Location:

This meeting was held June 13, 2014, beginning at 8:30 a.m. (EDT) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

FDA Campus Information

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Preliminary Agenda

TimeSubjectName of Speaker
8:30-8:35WelcomeAlberto Gutierrez (FDA)
8:35-8:50IntroductionJulia Lathrop (FDA)
8:50-9:15Prioritizing our Validation EffortsAndy Hoofnagle (UWashington)
9:15-9:35Development of omics-based tests for clinical use:  the challenge of achieving statistical robustness and clinical utilityLisa McShane (NCI)
9:55-10:15Validation of Assays for the Clinical Diagnostics LabRussell Grant (Labcorp)
10:15-10:45Questions for all speakers and BREAK 
10:45-12:30Community Initiatives Overview  
10:45-11:00NCI-Clinical Proteomic Tumor Analysis Consortium: Building A Standardized Proteogenomic Pipeline for Understanding Cancer BiologyEmily Boja (NCI)
11:00-11:15Translating Proteomics in Diabetes and Metabolic Diseases at the NIDDKSalvatore Sechi (NIDDK)
11:15-11:30Development and Usage of Reference Materials for Proteomics ResearchKaren Phinney (NIST)
11:30-11:45Human Proteome Organization InitiativesMaria Chan (FDA)
11:45-12:00Questions for all speakers 
12:45-13:10Working with FDA: Experiences in a Mock 510k Submission ProcessLeigh Anderson (SISPCAPA)
13:10-13:30Successful Validation and Clearance of MALDI-ToF MS for Microorganism identificationYvonne Shea (FDA)
13:30-15:00Clinical study design
Clinical and analytical issues related to assays producing a single score
Abraham Tzou (FDA) and Marina Kondratovich (FDA)
15:15-16:45Points for Discussion for Proteomic TechnologiesJulia Lathrop
16:45-17:00Wrap upMaria Chan

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Registration to Attend the Workshop:

As of June 4, 2014, online registration is now closed. On-site registration will be available.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661,

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Contact Us

For questions regarding workshop content please contact:

Julia Tait Lathrop, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66 Rm. 5534, Silver Spring, MD 20993, Tel: 240-402-5034, Email:

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Page Last Updated: 07/15/2014
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