ArticleJournal of clinical laboratory analysis2025
Analytical and Clinical Validation of Solo-Test Driver: A Targeted Amplicon-Based NGS Test-System for FFPE and cfDNA Analysis in Clinical Oncology Setting.
Article in Journal of clinical laboratory analysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
backgroundNext-generation sequencing (NGS) is increasingly integrated into cancer patient management, necessitating cost-effective, reliable tests for companion diagnostics. We present the validation of the Solo-test Driver panel, a custom NGS amplicon-based tool for DNA analysis of 34 oncogenes, addressing key clinical needs.
methodsThe panel's performance was validated for detecting SNVs, CNVs, and MSI. Analytical validation used 182 samples, while clinical validation involved 130 samples, both encompassing diverse tumor types and specimen formats.
resultsThe Solo-test Driver panel has the potential to identify an additional 18.3%, 16.5%, and 8.7% of RAS+ colorectal, PIK3CA+ breast, and EGFR+ lung cancer patients, respectively, when compared to FDA-approved PCR tests. Analytical validation demonstrated high intra-lab robustness (coefficient of variation of coverage uniformity 6.4%) and high inter-lab robustness (PCC of per-amplicon coverage 0.82, 0.84, 0.9 for three different labs). Estimated in silico sensitivity was 100% for detecting clinically actionable SNVs at 250x, corresponding to only 60,000 read pairs per sample. In vitro mixing experiments determined LoD starting from 3.3% VAF. Estimated in silico LoD ranged from 0.5% to 5% at 1000× (1% to 5% at 650x). Clinical validation demonstrated PPA/NPA of 100%/80%, 95%/100%, and 100%/100% for detecting MSI, SNVs, and CNVs, respectively.
conclusionsThe Solo-test Driver panel offers a reliable, cost-effective solution for detecting somatic alterations and genomic signatures, making it suitable for routine companion diagnostics in solid tumors.
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.