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A comprehensive next generation sequencing tissue assay for Asian-prevalent cancers-Analytical validation and performance evaluation with clinical samples. | LitMetric

AI Article Synopsis

  • A new cancer diagnostic assay has been developed and validated using over 200 clinical specimens from various Asian cancer types, integrating both clinical data and curated biomarkers for improved diagnosis and treatment.
  • The assay employs hybrid-capture probes to analyze DNA changes from 572 cancer-related genes and 91 RNA fusion partners, successfully detecting important biomarkers like microsatellite instability (MSI) and tumor mutation burden (TMB).
  • Results show the assay has high accuracy with 100% specificity and 99.9% sensitivity, identifying actionable genetic alterations in 65% of samples, demonstrating its effectiveness for diagnosing and guiding treatment in prevalent Asian cancers.

Article Abstract

A well-validated diagnostic assay with curated biomarkers complements clinicopathological factors to facilitate early diagnosis and ensure timely treatment delivery. This study focuses on an Asian-centric cancer diagnostic assay designed and thoroughly validated against commercially available standard references and a cohort of over 200 clinical specimens spanning 12 diverse Asian-centric cancer types. The assay uses hybrid-capture probes capable of profiling DNA aberrations from 572 cancer-related genes and 91 RNA fusion partners. The panel can detect clinically-tractable biomarkers such as microsatellite instability (MSI) and tumor mutation burden (TMB). Analytical evaluation demonstrated 100% specificity and 99.9% sensitivity within a ≥5% VAF limit of detection (LoD) for SNV/Indels. RNA-based fusion features an LoD of ≥5 copies per nanogram input when evaluated against commercial references. Excellent linearity and concordance were observed when benchmarking against orthogonal methods in identifying MSI status, TMB scores and RNA fusions. Actionable genetic alterations were identified in 65% of the clinical samples. These results demonstrate a molecular diagnostic assay that accurately detects genomic alterations and complex biomarkers. The data also supports an excellent performance of this assay for making critical diagnoses and well-informed therapeutic decisions in Asian prevalent cancers.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532579PMC
http://dx.doi.org/10.3389/fmolb.2022.963243DOI Listing

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