Non-Small Cell Lung Cancer Testing on Reference Specimens: An Italian Multicenter Experience.

Lung Molecular pathology Tumor biomarker

Journal

Oncology and therapy

ISSN: 2366-1089

Titre abrégé: Oncol Ther

Pays: New Zealand

ID NLM: 101677510

Informations de publication

Date de publication:
11 Jan 2024

Historique:

received: 08 09 2023

accepted: 02 11 2023

medline: 11 1 2024

pubmed: 11 1 2024

entrez: 10 1 2024

Statut: aheadofprint

Résumé

Biomarker testing is mandatory for the clinical management of patients with advanced non-small cell lung cancer (NSCLC). Myriads of technical platforms are now available for biomarker analysis with differences in terms of multiplexing capability, analytical sensitivity, and turnaround time (TAT). We evaluated the technical performance of the diagnostic workflows of 24 representative Italian institutions performing molecular tests on a series of artificial reference specimens built to mimic routine diagnostic samples. Sample sets of eight slides from cell blocks of artificial reference specimens harboring exon 19 EGFR (epidermal growth factor receptor) p.E746_AT50del, exon 2 KRAS (Kirsten rat sarcoma viral oncogene homologue) p.G12C, ROS1 (c-ros oncogene 1)-unknown gene fusion, and MET (MET proto-oncogene, receptor tyrosine kinase) Δ exon 14 skipping were distributed to each participating institution. Two independent cell block specimens were validated by the University of Naples Federico II before shipment. Methodological and molecular data from reference specimens were annotated. Overall, a median DNA concentration of 3.3 ng/µL (range 0.1-10.0 ng/µL) and 13.4 ng/µL (range 2.0-45.8 ng/µL) were obtained with automated and manual technical procedures, respectively. RNA concentrations of 5.7 ng/µL (range 0.2-11.9 ng/µL) and 9.3 ng/µL (range 0.5-18.0 ng/µL) were also detected. KRAS exon 2 p.G12C, EGFR exon 19 p.E736_A750del hotspot mutations, and ROS1 aberrant transcripts were identified in all tested cases, whereas 15 out of 16 (93.7%) centers detected MET exon 14 skipping mutation. Optimized technical workflows are crucial in the decision-making strategy of patients with NSCLC. Artificial reference specimens enable optimization of diagnostic workflows for predictive molecular analysis in routine clinical practice.

Identifiants

DOI: 10.1007/s40487-023-00252-5 PMID: 38200361

pubmed: 38200361

doi: 10.1007/s40487-023-00252-5

pii: 10.1007/s40487-023-00252-5

doi:

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : Regione Campania

ID : Monitoraggio ambientale, studio ed approfondimento della salute della popolazione residente in aree a rischio-In attuazione della D.G.R. Campanian.180/2019

Organisme : Regione Campania

ID : POR Campania FESR 2014-2020 Progetto "Sviluppo di Approcci Terapeutici Innovativi per patologie Neoplastiche resistenti ai trattamenti-SATIN

Organisme : Ministero della Salute

ID : This work has been partly supported by a grant from the Italian Health Ministry's research program (ID: NET-2016-02363853National Center for Gene Therapy and Drugs based on RNA Technology MUR-CN3 CUP E63C22000940007 to DS

Informations de copyright

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