ReviewTherapeutic innovation & regulatory science2025
Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation.
Review in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Natural language processing to develop a standardized lexicon for precision medicine in oncology.Journal of managed care & specialty pharmacy · 2026Article
- Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based Circulating Tumor DNA Assays, Version 2.0.JCO precision oncology · 2026Article
- Genomic innovations in cancer prevention, diagnosis, prognosis and precision therapeutics.Frontiers in genetics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The U.S. Food and Drug Administration (FDA) recommends concurrent development of targeted therapies with an associated companion diagnostic (CDx) as the optimal approach to provide patient access to novel, safe, and effective treatments. However, CDx validation often relies on clinical samples from pivotal clinical trials for the drug, which can be challenging, particularly when there is limited sample availability. A review of Summary of Safety and Effectiveness Data (SSED) documents for CDx approved for non-small cell lung cancer (NSCLC) revealed that CDx for rare biomarkers often use alternative samples for validation. While the practice of using alternative samples for validation occurs, it is not always clear when these flexibilities are considered or how alternative samples should be used for validation. To address this, we propose the FDA establish guidance for the use of alternative sample sources for CDx validation, especially for rare biomarkers, to ensure timely and effective patient access to targeted therapies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.