Liquid biopsy mutation panel for non-small cell lung cancer: analytical validation and clinical concordance

Author:

Schwartzberg Lee S.,Horinouchi HidehitoORCID,Chan David,Chernilo Sara,Tsai Michaela L.,Isla Dolores,Escriu Carles,Bennett John P.ORCID,Clark-Langone Kim,Svedman Christer,Tomasini Pascale,Alexander Gregory,Baehner Frederick L.,Bauer Thomas,Bergamaschi Anna,Crown John,Davison Deborah,Eberhard David A.,Gabrail Nashat,Han James,Irvin William,Lopatin Margarita,Orsini James,Sumrall Bradley T.,

Abstract

AbstractMolecular testing for genomic variants is recommended in advanced non-small cell lung cancer (NSCLC). Standard tissue biopsy is sometimes infeasible, procedurally risky, or insufficient in tumor tissue quantity. We present the analytical validation and concordance study of EGFR variants using a new 17-gene liquid biopsy assay (NCT02762877). Of 144 patients enrolled with newly diagnosed or progressive stage IV nonsquamous NSCLC, 140 (97%) had liquid assay results, and 117 (81%) had both EGFR blood and tissue results. Alterations were detected in 58% of liquid samples. Overall tissue-liquid concordance for EGFR alterations was 94.0% (95% CI 88.1%, 97.6%) with positive percent agreement of 76.7% (57.7%, 90.1%) and negative percent agreement of 100% (95.8%, 100%). Concordance for ALK structural variants was 95.7% (90.1%, 98.6%). This assay detected alterations in other therapeutically relevant genes at a rate similar to tissue analysis. These results demonstrate the analytical and clinical validity of this 17-gene assay.

Funder

Genomic Health

Publisher

Springer Science and Business Media LLC

Subject

Computer Science Applications,History,Education

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