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Published on: April 11, 2016
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and
Kaku Saito1,2, Mamoru Narukawa3
1Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan. kakuxchloe0109@gmail.com.
Background:
Companion diagnostics (CDxs) are central to precision oncology, enabling identification of patients most likely to benefit from targeted therapies. Their quantitative impact on anticancer drug development timelines and regulatory outcomes has not been fully defined, and co-development often poses logistical and regulatory challenges.
Methods:
We reviewed 354 oncology indications across 127 anticancer drugs approved by the U.S. Food and Drug Administration between 2014 and 2024. Indications were classified by CDx requirement. Clinical, molecular, and regulatory features were compared between CDx and non-CDx indications. Multivariable logistic regression analysis identified factors associated with CDx adoption, and multivariable linear regression restricted to new molecular entities assessed associations with development timelines.
Results:
CDx-associated approvals increased steadily, comprising 43% of all oncology indications by 2022. CDx use was significantly associated with low-prevalence biomarkers (odds ratio [OR] 49.07), intermediate-prevalence biomarkers (OR 6.88), enzyme targets (OR 14.56), kinase targets (OR 5.18), and solid tumors (OR 3.65) compared with high-prevalence biomarkers, receptor targets, and hematologic tumors. Neither sponsor size nor orphan drug designation influenced CDx adoption. In regression models of new molecular entities, CDx presence was associated with a mean reduction in development time of 379.5 days (p = 0.006), similar in magnitude to Breakthrough Therapy Designation. Accelerated timelines were largely attributable to increased likelihood of early-phase approvals.
Conclusion:
CDx co-development enriches trial populations and facilitates initial approvals, particularly for molecularly defined solid tumors with low- or intermediate-prevalence biomarkers. Early, indication-specific integration of CDx, combined with regulatory accelerators, provides a pragmatic strategy to enhance trial efficiency, shorten development timelines, and expand timely patient access to life-prolonging therapies.
Insights
Companion diagnostics (CDx) accelerate anticancer drug development, reducing timelines by over 300 days. Integrating CDx early streamlines clinical trials and improves patient access to targeted therapies.
Area of Science:
- Oncology
- Biomarkers
- Drug Development
Background:
- Companion diagnostics (CDx) are crucial for precision oncology, identifying patients for targeted therapies.
- The quantitative impact of CDx on drug development timelines and regulatory outcomes requires further definition.
- Co-development of CDx and therapeutics presents logistical and regulatory challenges.
Purpose of the Study:
- To quantify the impact of companion diagnostics (CDx) on anticancer drug development timelines.
- To identify factors associated with CDx adoption in oncology.
- To assess the relationship between CDx and regulatory outcomes for new molecular entities.
Main Methods:
- Review of 354 oncology indications for 127 anticancer drugs approved by the FDA (2014-2024).
- Classification of indications by CDx requirement and comparison of clinical, molecular, and regulatory features.
- Multivariable regression analyses to identify factors associated with CDx adoption and impact on development timelines.
Main Results:
- CDx-associated approvals increased significantly, reaching 43% of oncology indications by 2022.
- CDx use was strongly linked to low-prevalence biomarkers, enzyme/kinase targets, and solid tumors.
- CDx presence reduced development time by a mean of 379.5 days, primarily through earlier phase approvals.
Conclusions:
- CDx co-development enhances trial populations and facilitates initial approvals, especially for molecularly defined solid tumors.
- Early, indication-specific CDx integration with regulatory accelerators improves trial efficiency and shortens development timelines.
- This strategy expands timely patient access to life-prolonging precision oncology therapies.
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