Will the FDA/CDER qualify an epigenetic clock or other biomarker of aging as a drug-development tool by 30 Jun 2029?
Chance it happens
40%Belief the predicted event happens at all — every “yes / by-a-date” outcome added together. “Other” is tracked as its own third slice.
Outcomes
Resolution criteria
The FDA accepts a biomarker of aging into its Biomarker Qualification Program (BQP) as a drug-development tool. Resolution horizon: 2029-06-30. Source: FDA BQP.
Evidence & context
Trials, publications and reports our research found on this prognosis. Each links to the original source.
This is a 2025 news/article summary discussing the FDA's Biomarker Qualification Program and reporting that the agency has only qualified eight biomarkers, with slow progress since the 21st Century Cures Act. It bears on the forecast because it directly describes the pace and output of the BQP, informing how likely FDA/CDER may be to qualify an aging biomarker by June 30, 2029.
This appears to be a scholarly article hosted on PubMed Central about the FDA/CDER Biomarker Qualification Program. It bears on the prediction because it discusses BQP timelines and process, which are directly relevant to judging whether an aging biomarker could be qualified by 30 Jun 2029.
This appears to be a scientific publication describing DunedinPACE, a DNA methylation biomarker intended to measure pace of aging. It is relevant because development and validation of aging biomarkers is a prerequisite to any future FDA Biomarker Qualification Program acceptance as a drug-development tool.
This appears to be a scientific publication describing and validating DunedinPACE, a DNA methylation biomarker intended to measure pace of aging. It is relevant because the existence and validation of candidate aging biomarkers bears directly on whether one could later be accepted by FDA/CDER's Biomarker Qualification Program as a drug-development tool.
This is a 2026 medRxiv preprint evaluating several epigenetic aging measures, including DunedinPACE, in relation to cognitive decline in older adults. It is indirect but relevant evidence because it reflects ongoing validation and comparative performance assessment of epigenetic clocks as candidate aging biomarkers, which informs their plausibility for eventual FDA biomarker qualification.
This is a TruDiagnostic company blog discussing epigenetic clocks, especially DunedinPACE, and argues about their suitability as age-related biomarkers. It bears on the forecast indirectly because it reflects commercial and scientific positioning around candidate aging biomarkers, but it is not FDA qualification evidence itself.
This appears to be an FDA/CDER explainer about the Biomarker Qualification Program, the exact program named in the resolution criteria. It is relevant because it can clarify how qualification works and what standards a biomarker of aging would need to meet, though it is not itself evidence that any aging biomarker has been qualified.