Validation of the biomarker toolkit using diagnostic colorectal cancer biomarkers – an evidence-based tool to support clinical adoption of biomarkers
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Background
Biomarkers offer valuable insights into diseases and bodily functions, yet many fail to achieve clinical implementation. Our recent research revealed a substantial translational gap, with only 0.94% of prognostic breast cancer biomarkers and 0.14% of diagnostic colorectal cancer biomarkers reaching clinical practice. To address this challenge, we developed the Biomarker Toolkit, designed to enhance translational outcomes by identifying cancer biomarkers most likely to succeed and highlighting areas requiring further research. This study aims to validate the Toolkit using a new dataset of diagnostic colorectal cancer biomarkers.
Methods
Systematic literature searches were conducted to identify clinical studies for successful and stalled diagnostic colorectal cancer biomarker groups. ‘Successful’ biomarkers were defined as those approved for diagnostic use in colorectal cancer by regulatory bodies. For the stalled cohort, a random selection of biomarkers associated with > 5 publications was drawn from a previous review, until the number of clinical studies in each cohort was equal. Each clinical study was examined for the presence or absence of 125 attributes present in the Toolkit, with a binary score (1 or 0) assigned accordingly. Total and category scores were calculated and compared between the successful and stalled biomarker groups, using Mann Whitney U Test, binary logistic and Cox regression analyses.
Results
Using the Toolkit, successful diagnostic colorectal cancer biomarkers demonstrated significantly higher total scores compared to the stalled group (44.7% versus 25.1%, p < 0.001). Successful biomarkers exhibited higher clinical utility scores even before receiving regulatory approval (42.1% versus 20.2%, p < 0.001). Additionally, the frequency and diversity of clinical utility publications for successful biomarkers continued to rise beyond the initial five-year period following the first biomarker publication.
Conclusions
This study provides independent validation of the Biomarker Toolkit, having been initially validated using prognostic breast cancer biomarkers. The significantly higher Toolkit scores observed in successful diagnostic colorectal cancer biomarkers, particularly in clinical utility, even before regulatory approval, underscore the Toolkit’s strong potential for predicting translational success.
Biomarkers offer valuable insights into diseases and bodily functions, yet many fail to achieve clinical implementation. Our recent research revealed a substantial translational gap, with only 0.94% of prognostic breast cancer biomarkers and 0.14% of diagnostic colorectal cancer biomarkers reaching clinical practice. To address this challenge, we developed the Biomarker Toolkit, designed to enhance translational outcomes by identifying cancer biomarkers most likely to succeed and highlighting areas requiring further research. This study aims to validate the Toolkit using a new dataset of diagnostic colorectal cancer biomarkers.
Methods
Systematic literature searches were conducted to identify clinical studies for successful and stalled diagnostic colorectal cancer biomarker groups. ‘Successful’ biomarkers were defined as those approved for diagnostic use in colorectal cancer by regulatory bodies. For the stalled cohort, a random selection of biomarkers associated with > 5 publications was drawn from a previous review, until the number of clinical studies in each cohort was equal. Each clinical study was examined for the presence or absence of 125 attributes present in the Toolkit, with a binary score (1 or 0) assigned accordingly. Total and category scores were calculated and compared between the successful and stalled biomarker groups, using Mann Whitney U Test, binary logistic and Cox regression analyses.
Results
Using the Toolkit, successful diagnostic colorectal cancer biomarkers demonstrated significantly higher total scores compared to the stalled group (44.7% versus 25.1%, p < 0.001). Successful biomarkers exhibited higher clinical utility scores even before receiving regulatory approval (42.1% versus 20.2%, p < 0.001). Additionally, the frequency and diversity of clinical utility publications for successful biomarkers continued to rise beyond the initial five-year period following the first biomarker publication.
Conclusions
This study provides independent validation of the Biomarker Toolkit, having been initially validated using prognostic breast cancer biomarkers. The significantly higher Toolkit scores observed in successful diagnostic colorectal cancer biomarkers, particularly in clinical utility, even before regulatory approval, underscore the Toolkit’s strong potential for predicting translational success.
Date Issued
2026-12-01
Date Acceptance
2026-04-12
Citation
Journal of Translational Medicine, 2026, 24 (1)
ISSN
1479-5876
Publisher
BMC
Journal / Book Title
Journal of Translational Medicine
Volume
24
Issue
1
Copyright Statement
© The Author(s) 2026. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
License URL
Identifier
10.1186/s12967-026-08143-9
Publication Status
Published
Article Number
ARTN 895
Date Publish Online
2026-05-19