2021
DOI: 10.1002/onco.13905
|View full text |Cite
|
Sign up to set email alerts
|

Validation of a Circulating Tumor DNA-Based Next-Generation Sequencing Assay in a Cohort of Patients with Solid tumors: A Proposed Solution for Decentralized Plasma Testing

Abstract: Characterization of circulating tumor DNA (ctDNA) has been integrated into clinical practice. While labs have standardized validation procedures to develop single locus tests, the efficacy of on-site plasma-based next-generation sequencing (NGS) assays still need to be proven. In this retrospective study, we profiled DNA from matched tissue and plasma samples from 75 cancer patients. We applied the NGS test PGDx elio™ plasma resolve-RUO (EPR), which detects clinically relevant alterations in 33 genes and micro… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
1
1
1

Citation Types

0
8
0

Year Published

2022
2022
2024
2024

Publication Types

Select...
6

Relationship

0
6

Authors

Journals

citations
Cited by 14 publications
(8 citation statements)
references
References 32 publications
0
8
0
Order By: Relevance
“…NGS libraries were prepared from cfDNA and fragmented genomic WBC DNA using a target of 40 ng of sample input through end-repair, A-tailing and adapter ligation with custom molecular barcoded adapters. Subsequently, libraries were PCR amplified, and target enrichment was performed through in-solution hybrid capture using the PGDx elio plasma resolve 33-gene panel 17 , 32 . Finally, libraries were pooled and sequenced with 150-bp paired-end reads using the Illumina NextSeq 550 platform.…”
Section: Methodsmentioning
confidence: 99%
“…NGS libraries were prepared from cfDNA and fragmented genomic WBC DNA using a target of 40 ng of sample input through end-repair, A-tailing and adapter ligation with custom molecular barcoded adapters. Subsequently, libraries were PCR amplified, and target enrichment was performed through in-solution hybrid capture using the PGDx elio plasma resolve 33-gene panel 17 , 32 . Finally, libraries were pooled and sequenced with 150-bp paired-end reads using the Illumina NextSeq 550 platform.…”
Section: Methodsmentioning
confidence: 99%
“…Various technologies are commonly used for ctDNA genomic profiling in clinical settings. These include amplification-refractory mutation system (ARMS) polymerase chain reaction (PCR) or ARMS-PCR assays, , pyrophosphorolysis-activated polymerization (PAP) assays, , digital methods such as beads, emulsion, amplification, and magnetics (BEAMing), droplet digital PCR (ddPCR), , and next-generation sequencing (NGS) assays. , However, fluorescent assays typically exhibit lower analytical and clinical sensitivities, ranging from 75 to 100 copies/mL and 70% sensitivity, respectively . Digital PCR has proven to be more sensitive than ARMS-PCR assays; however, its multiplexing capability is limited, and it requires specialized equipment to partition samples into individual droplets .…”
Section: Gmr Biosensors For Cancer Screening and Detectionmentioning
confidence: 99%
“…The expected TAT for the currently commercially available ctDNA CGP assays is within 7-10 days [87,88], which coincides with the current observations. However, the current TAT can potentially be further shortened with a more flexible and decentralized sequencing system, which can be placed at the point of care and operated with minimal technical supervision [89][90][91]. Such an automated NGS system would need further analytical and clinical validation for its use in clinical settings.…”
Section: Shorter Turnaround Time (Tat) With Improved Clinical Trial E...mentioning
confidence: 99%