Testing Considerations

Tissue testing can be ordered for diagnosis, staging, and to identify actionable and emerging biomarkers1*

Testing Journey
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Detection

The primary purpose of specimens intended for initial diagnoses is to make an accurate diagnosis and preserve tissue for molecular studies

In resection specimens, the primary purpose is to classify the histologic subtype and determine staging1*
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Diagnosis & Staging

Broad molecular profiling should be carried out on samples to help identify patients that may be eligible for targeted therapies1*
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Treatment Decisions

Serial biopsies to track tumor evolution and response to therapy can be helpful in informing treatment decisions, but can carry challenges, including complications from invasive diagnostic procedures2

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Follow-up

Testing for a broad array of DNA, RNA, and protein biomarkers is important for informing disease management, but tissue insufficiency can be a challenge2

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*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Tissue Insufficiency

Tissue insufficiency in NSCLC impacts biomarker testing, which can inform disease management and the identification of patients that may be eligible for targeted therapies2–4

Overview
Technical Considerations
Patient Considerations
Disease Impact
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Tissue quantity and quality can vary across patient cases, making testing difficult2–4
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Tissue from patients may not be available for testing2
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Inability to perform testing due to tissue insufficiency may impact disease management2
These challenges can impact disease management and the identification of patients that may be eligible for targeted therapies2–4
Tissue quantity and quality can vary across patient cases, making testing difficult2–4
Of NSCLCs are resectable at the time of presentation
Of biopsies are inadequate for molecular testing due to insufficient tissue or amplifiable DNA
Biopsy specimens can be exhausted for other diagnostic purposes
Tumor sampling has generally moved towards less invasive procedures, which yield smaller samples
Tissue from patients may not be available for testing2
Patients may not have enough tissue for testing
Patients may lack biopsy-amenable lesions
Patients may not want to go through repeat biopsies
Inability to perform testing due to tissue insufficiency may impact disease management2
Diagnosis
Treatment selection
Understanding of tumor biology
Evaluation of treatment response or disease progression

NSCLC=non-small cell lung cancer.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Small Cell Lung Cancer (Version 7.2024) recommend broad molecular profiling to minimize tissue use and potential wastage in NSCLC1*

A major limitation in obtaining tissue molecular testing results for NSCLC occurs when minimally invasive techniques are used to obtain samples
Tissue yield may be insufficient for molecular, biomarker, and histologic testing. HCPs should procure sufficient tissue to enable all appropriate testing

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

ctDNA=circulating tumor DNA; FISH=fluorescence in situ hybridization; HCP=healthcare provider; IHC=immunohistochemistry; NGS=next-generation sequencing; NSCLC=non-small cell lung cancer; PD-L1=programmed death-ligand 1; RT-PCR=reverse transcription polymerase chain reaction.

Learn more about NSCLC
pathobiology and biomarkers
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References
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  2. Liam CK, Mallawathantri S, Fong KM. Is tissue still the issue in detecting molecular alterations in lung cancer? Respirology. 2020;25(9):933-943. doi:10.1111/resp.13823
  3. Fox AH, Nishino M, Osarogiagbon RU, et al. Acquiring tissue for advanced lung cancer diagnosis and comprehensive biomarker testing: a National Lung Cancer Roundtable best-practice guide. CA Cancer J Clin. 2023;73(4):358-375. doi:10.3322/caac.21774
  4. Kim L, Tsao MS. Tumour tissue sampling for lung cancer management in the era of personalised therapy: what is good enough for molecular testing? Eur Respir J. 2014;44(4):1011-1022. doi:10.1183/09031936.00197013
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