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 Description | Milestone Date | Milestone Status | Milestone 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 Description | Milestone Date | Milestone Status | Milestone 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. Develop draft technical report/manuscript/publication |
TBD |
Not Yet Started | |
|
5. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publication |
TBD |
Not Yet Started | |
|
6. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system |
TBD |
Not Yet Started | |
|
7. Submit final technical report, manuscript and/or publication to a scientific journal |
TBD |
Not Yet Started |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
