FAQs on Biomarker testing | iD.Lung | Healthcare Professionals

Why is biomarker testing important for patients with NSCLC?

Biomarker testing gives HCPs an insight into each patient’s disease, helping them to select the most appropriate treatment for their tumour.

To learn more, visit the iD Lung website page on Biomarker Testing in Lung Cancer

Which biomarkers should I test
for in a patient with early-stage
(Stage I–III) NSCLC?

Some guidelines recommend routine testing
for EGFR mutations, ALK gene fusions, and
PD-L1 protein expression in patients with
early-stage* NSCLC.^1-3

To learn more, visit the iD Lung website page on Biomarker Testing in Lung Cancer

Which biomarkers should I test for in
a patient with advanced or metastatic
(Stage IV) NSCLC?

Most guidelines recommend patients
with advanced NSCLC should be tested for clinically actionable biomarkers. These may include EGFR mutations, ALK gene fusions, ROS1 gene rearrangements, BRAF mutations, KRAS G12C mutations, MET exon 14 skipping mutations, RET gene rearrangements,
HER2 mutations, NTRK1/2/3 gene fusions,
and PD-L1 protein expression.^1,3

To learn more, visit the iD Lung website page on Biomarker Testing in Lung Cancer

When should biomarker testing be
carried out for in a patient with NSCLC?

Patients with NSCLC should receive biomarker testing at initial diagnosis and when the disease has progressed.^{1, 4}

To learn more, visit the iD Lung website page on Biomarker Testing in Lung Cancer

Who is responsible for
implementing biomarker testing for
patients with NSCLC?

The HCP who is responsible for organising biomarker testing may vary between
countries and institutions. Typically, an oncologist will identify the biomarker tests needed for each patient. In some cases, a pathologist may order biomarker tests; this practice, known as reflex testing, may be performed in order to obtain biomarker testing results in a timely manner to inform treatment decisions.^{5, 6}

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Which specimens are used to test for molecular biomarkers in NSCLC?

Tumour tissue is the gold standard for biomarker testing in NSCLC. For certain biomarker tests, cytological or plasma samples may be used in the absence of a tumour biopsy.^1,4,7,8

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Which specimens are used to test for
PD-L1 protein expression in NSCLC?

FFPE tumour tissue samples are routinely used to determine PD-L1 protein expression^9–16
FFPE cytological samples obtained by fine-needle aspiration may be used with the VENTANA PD-L1 (SP263) Assay.¹⁷

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How are tissue and cytological specimens obtained for biomarker testing in NSCLC?

Biopsies may be obtained using surgical and non-surgical methods. Surgical techniques include VATS (using a thoracoscope) and mediastinoscopy.^18,19 Cytological samples can be obtained by bronchial brushing (using a bronchoscope), EUS-FNA (using an endoscope), and EBUS-TBNA (using an endobronchial ultrasound probe).^20–22 Plasma samples can also be used to collect ctDNA for biomarker testing.²³

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How do I test for molecular biomarkers
in NSCLC?

Methods of biomarker testing for genomic alterations in NSCLC include: RT-PCR (to detect point mutations, 
insertions and deletions);^1,24 FISH (to detect translocations, insertions and deletions),²⁵ IHC (to detect fusions and rearrangements)^26–29, and NGS (to detect mutations, insertions, deletions, copy number alterations and 
gene rearrangements).²⁴

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How do I test for
PD-L1 protein expression?

IHC is used to determine PD-L1 protein expression. ³⁰ To determine PD-L1 expression status, processed samples are stained with
PD-L1 antibodies using an automated staining platform. A scoring system is then used to determine whether the tumour is PD-L1 positive or negative. The type of PD-L1 antibody, staining procedure, and scoring algorithm used differs between PD-L1 IHC assays. ^9-16

To learn more, visit the iD Lung website page on Technical Considerations

*Per NCCN Guidelines^®, testing in early-stage NSCLC is recommended for Stages IB-IIIA, IIIB (T3,N2)

ABBREVIATIONS:
ALK, anaplastic lymphoma kinase; BRAF, B-Raf proto-oncogene; ctDNA, circulating tumour DNA; EBUS-TBNA, endobronchial ultrasound-guided transbronchial needle aspiration; EGFR, epidermal growth factor receptor; EUS-FNA, endoscopic ultrasound-guided fine needle aspiration; FAQ, frequently asked question; FFPE, formalin-fixed, paraffin-embedded; FISH, fluorescent in situ hybridisation; HCP, healthcare professional; HER2, human epidermal growth factor receptor 2; KRAS, Kirsten rat sarcoma virus; MET, MET proto-oncogene, receptor tyrosine kinase; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer; NTRK, neurotrophic receptor tyrosine kinase; PD-L1, programmed cell death ligand-1; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1; RT-PCR, real-time polymerase chain reaction; VATS, video-assisted thoracoscopic surgery

REFERENCES:

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®)
for Non-Small Cell Lung Cancer V.11.2024. © National Comprehensive
Cancer Network, Inc. 2024. All rights reserved. Accessed October 28, 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.
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