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U.S. Department of Health and Human Services

About FDA

Integrated Techniques, Approaches, and Technologies for the Characterization of Genomic and Proteomic Biomarkers Measures

Description: Development of techniques to analyze biological specimens for biomarkers of disease or therapeutic response. Results of OR's project will support CVM's ONADE in establishing/evaluating efficacy claims for new animal drug applications. The data generated will be used in the review and evaluation of the efficacy of new and existing veterinary therapeutics.

Definition: In vivo diagnosis of several diseased states relies on the use of biomarkers, which are substances produced in the body used to examine specific aspects of one's health. Here, the Office of Research is evaluating biomarkers of inflammation of the goat mammary gland. A proteomic analysis, which is the study of proteins, of milk from the mammary glands of infected goats would provide a preliminary assessment of the properties and specificity of biomarkers that could successfully be used to develop treatments for mastitis.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Initiate research protocol to further investigate protein biomarkers of mastitis


Completed 5/31/2010

2. Initiate animal phase of study to determine biomarkers of inflammation


Completed 8/12/2010

3. Initiate investigation of genetic biomarkers of inflammation


Completed 10/1/2010

4. Initiate the study of protein biomarkers of inflammation


Completed 11/1/2010

5. Develop general approaches and analytical techniques for proteomic analysis of complex biological matrices


Completed 12/30/2010

6. Complete identification and data of protein biomarkers of inflammation in the goat mammary gland




Completed 9/24/2012

7. Publish manuscript





Completed 5/2013 and 6/2013

8. Provide CVM reviewers with biomarker response patterns data that may be used by industry to support anti-inflammatory claims for new veterinary drugs



Completed 11/2/2012

9. Provide expert consultation to CVM reviewers for evaluation or proteomic data submitted in support of new animal drug applications



Completed 11/2/2012


  • The dates in italics under the milestone due dates are modified due dates which had to be updated due to real-time delays. The milestone status reflects the modified dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.



measurable characteristics that indicate the transition between biological states (i.e. healthy or diseased)


Office of New Animal Drug Evaluation

In vivo

in the living organism


inflammation of breast tissue

proteomic analysis

the study of proteins

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.