Expert opinion on NSCLC small specimen biomarker testing — Part 2: Analysis, reporting, and quality assessment
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Published:2022-07-20
Issue:3
Volume:481
Page:351-366
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ISSN:0945-6317
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Container-title:Virchows Archiv
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language:en
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Short-container-title:Virchows Arch
Author:
Penault-Llorca Frédérique, Kerr Keith M., Garrido Pilar, Thunnissen Erik, Dequeker Elisabeth, Normanno Nicola, Patton Simon J., Fairley Jenni, Kapp Joshua, de Ridder Daniëlle, Ryška Aleš, Moch HolgerORCID
Abstract
Abstract
The diagnostic work-up for non-small cell lung cancer (NSCLC) requires biomarker testing to guide therapy choices. This article is the second of a two-part series. In Part 1, we summarised evidence-based recommendations for obtaining and processing small specimen samples (i.e. pre-analytical steps) from patients with advanced NSCLC. Here, in Part 2, we summarise evidence-based recommendations relating to analytical steps of biomarker testing (and associated reporting and quality assessment) of small specimen samples in NSCLC. As the number of biomarkers for actionable (genetic) targets and approved targeted therapies continues to increase, simultaneous testing of multiple actionable oncogenic drivers using next-generation sequencing (NGS) becomes imperative, as set forth in European Society for Medical Oncology guidelines. This is particularly relevant in advanced NSCLC, where tissue specimens are typically limited and NGS may help avoid tissue exhaustion compared with sequential biomarker testing. Despite guideline recommendations, significant discrepancies in access to NGS persist across Europe, primarily due to reimbursement constraints. The use of increasingly complex testing methods also has implications for the reporting of results. Molecular testing reports should include clinical interpretation with additional commentary on sample adequacy as appropriate. Molecular tumour boards are recommended to facilitate the interpretation of complex genetic information arising from NGS, and to collaboratively determine the optimal treatment for patients with NSCLC. Finally, whichever testing modality is employed, it is essential that adequate internal and external validation and quality control measures are implemented.
Funder
Amgen (Europe) GmbH University of Zurich
Publisher
Springer Science and Business Media LLC
Subject
Cell Biology,Molecular Biology,General Medicine,Pathology and Forensic Medicine
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