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U.S. Department of Health and Human Services

About FDA

Develop and Validate Genetic Biomarkers

Description: Develop research techniques to produce new biomarkers and evaluate existing biomarkers. This research has widespread interest and is a collaborative FDA effort involving CDER, CFSAN, CVM, and CDRH.

Definition: NCTR promotes personalized nutrition and medicine by developing a broad range of studies involving systems toxicology assessments to characterize biomarkers of health, disease risk and disease status. These biomarkers will aid the FDA in establishing risk measures for FDA-regulated products and assessing the benefits and potential risk of treatments in a personalized nutrition and medicine paradigm.

Developing and validating genetic biomarkers will better enable the FDA to identify persons most likely to benefit from, or experience adverse reactions to, particular drugs, devices, biologics, cosmetics and nutrients. This will reduce the rate of adverse events in patients.

Public Health Outcome: When developed and validated, this new assay which helps to distinguish between chemicals that can cause genetic damage/cancer and those that are safe will provide a better method for use in FDA product safety evaluations such as preclinical safety evaluation for pharmaceuticals.

Accomplishment: Phase 1: National Center for Toxicological Research (NCTR) scientists have authored an invited book chapter for an upcoming volume of Molecular Toxicology Protocols (Methods in Molecular Biology series). The chapter details methods for conducting the Pig-a gene mutation assay in mice and rats. The Pig-a assay is a flow-cytometer-based assay that can be used to assess the in vivo mutagenic potential of suspected toxicants. The assay is rapid, relatively inexpensive, and is functional across species (mice-to-human), making it a potentially valuable tool for regulatory safety assessments.

1. Phase 1

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Present and discuss genetic biomarker research to support personalized nutrition and health (to date) with the scientific community at the Society for Toxicology Meeting

3/31/2010

Completed 3/31/2010

2. Present and discuss genetic biomarker research to establish risk measures (to date) with the scientific community at the Society for Toxicology Meeting

3/31/2010

Completed 3/31/2010

3. Approve protocol for a new study to evaluate a new mutation biomarker for its utility in detecting chemically induced mutations at low levels of exposure

5/31/2010

Completed 5/31/2010

4. Complete discussions with collaborators in CDER, CFSAN, CVM, and CDRH to gain input into the development of a research program for new mutational and cancer biomarkers

5/31/2010

Completed 5/31/2010

5. Complete the evaluation of a new mutational biomarker using an initial set of chemicals in a multi-laboratory collaborative trial

6/30/2010

Completed 6/30/2010

6. Complete training of a postdoctoral fellow in specialized molecular techniques involved in cancer biomarker research

6/30/2010

Completed 6/30/2010

7. Complete and submit a manuscript for an overview of cancer biomarkers research

7/30/2010

Completed 7/30/2010

8. Complete and submit a manuscript to provide an overview of the current methodology for a new biomarker assay using the Pig-A gene; this gene mutation assay will detect the ability of chemicals/pharmaceuticals to induce genetic damage

7/30/2010

Completed 7/30/2010

2. Phase 2

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Complete a second set of experiments investigating the utility and capabilities of the new gene mutation assay using the Pig-A gene

9/30/2011

Completed 9/30/2011

2. Complete a third set of experiments

9/30/2012

Completed 9/30/2012

3. Complete the assessment of research findings for this project

1/1/2013

Completed 1/1/2013

4. Initiate an additional experiment with an additional chemical based on the assessment of research findings to date

8/1/2013

Completed 8/1/2013

5. Submit consensus assay on additional test compound

6/1/2014

Completed 6/1/2014

6. Assay an additional test compound

8/1/2014

Completed 9/2/2014

7. Develop draft technical report/manuscript/publication

1/1/2014

(1/1/2015)

On Track

8. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publication

TBD

Not Yet Started

9. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

TBD

Not Yet Started

10. Submit final technical report, manuscript and/or publication to a scientific journal

TBD

Not Yet Started

Footnotes

  • The dates in italics are modified milestone due dates that have been updated due to real-time delays. The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

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.

Glossary

biomarkers

measurable endpoints that are either precursors for or surrogate indicators for disease

CDER

Center for Drug Evaluation and Research

CFSAN

Center for Food Safety and Applied Nutrition

CVM

Center for Veterinary Medicine

CDRH

Center for Devices and Radiological Health

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.