ArticleJCO precision oncology2026
Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based Circulating Tumor DNA Assays, Version 2.0.
Article in JCO precision oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Circulating tumor DNA (ctDNA) is a promising biomarker for cancer detection, treatment selection, and disease monitoring. As a result, an increasing number of diagnostic developers are pursuing liquid biopsy assays using next-generation sequencing (NGS) to detect ctDNA. To support clinical adoption, these assays must undergo rigorous analytical validation (AV) to facilitate regulatory approval, support market entry, and ultimately improve outcomes for patients with cancer. To this end, the BLOODPAC AV Working Group developed and published a set of generic AV protocols in September 2020. These included 11 protocols and 4 standard methods designed as a foundational resource for in vitro diagnostic developers, support validation discussions with regulatory bodies, promote alignment between pharmaceutical and diagnostic partners, and help reduce regulatory review cycles by standardizing expectations for study design. In 2023, after over 2 years of practical application, BLOODPAC launched an open comment period (April-July 2023) to gather user feedback. Nine institutions provided comments, which were reviewed by the Working Group and aggregated with feedback received from the (US) Food and Drug Administration via presubmission process. This input informed the development of the updated version to ensure the protocols remain practical, scientifically robust, and aligned with current technologies. This paper outlines the feedback process, reviews key challenges identified, and summarizes the resulting changes. It presents the second iteration (version 2.0) of the BLOODPAC generic AV protocols, reaffirming the consortium's commitment to maintaining their relevance, usability, and scientific rigor.
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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.