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Clinical information

Lung cancer is the most common cancer worldwide, contributing for 13% of all cancer types. 85% of lung cancers are non-small cell lung cancers (NSCLC), of which histologically adenocarcinoma is the most prevalent.

EGFR mutations in exons 18-21 have been associated with sensitivity and resistance to a number of targeted anti-cancer therapeutics and testing is recommended in all patients with advanced NSCLC of a nonsquamous subtype.1  2  Exon 19 deletion and exon 21 (L858R, L861Q), exon 18 (G719X), and exon 20 (S768I) mutations are associated with sensitivity to EGFR tyrosine kinase inhibitors (TKI’s) whereas exon 20 insertion mutations may predict resistance to TKI’s. EGFR T790M mutation is the main cause of acquired resistance to TKI therapy and has been reported in about 55% of patients with disease progression after initial response to 1st or 2nd generation TKI’s.3  4  Prevalence of EGFR mutations in NSCLC adenocarcinomas is 10-15% in Western and up to 50% in Asian patients.5

Gene fusions represent an important class of gene rearrangements and have become important in NSCLC, as they are linked to responses to certain targeted therapies. Their accurate and fast detection is critical to guide therapy choices, which is the reason why testing for gene rearrangements such as gene fusions is included in international NSCLC testing guidelines (including ESMO and NCCN).

However, comprehensive testing of actionable gene rearrangements in NSCLC are often complex and can require different technologies.6 In order to test all needed biomarkers, laboratories usually have to use different instruments which are often not available within their own lab. Using different instruments also requires having enough biopsy samples of sufficient good quality, which can be difficult to obtain, especially in NSCLC patients.

  • 1National Comprehensive Cancer Network website. NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer Version 6. 2017. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 2018
  • 2Novello S. et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol (2016) 27 (suppl 5): v1-v27; Accessed August 2018
  • 3National Comprehensive Cancer Network website. NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer Version 6. 2017. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 2018
  • 4Novello S. et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol (2016) 27 (suppl 5): v1-v27; Accessed August 2018
  • 5Cooper WA et al. J Thorac Dis 2013; 5 (S5): S479-490. Molecular Biology of lung cancer
  • 6I.e. gene fusions and METex14 skipping. Techniques used to detect NTRK gene fusions include DNA-based next-generation sequencing (NGS), RNA-based NGS, reverse-transcriptase PCR (RT-PCR), fluorescence in situ hybridisation (FISH), and immunohistochemistry (IHC). Source: OncologyPro, ESMO, last consulted on 2 June 2022: https://oncologypro.esmo.org/oncology-in-practice/anti-cancer-agents-an…

In vitro diagnostic tests

IDYLLA™ FIRST

Guiding First-Line Therapy Decisions in NSCLC

Idylla First Lung Leaflet

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Idylla EGFR Mutation Test

Idylla EGFR Mutation Test

IdyllaTM EGFR provides fast, reliable information on the EGFR tumor mutation status reducing the clinical turnaround time from sample to result report significantly. This can make EGFR test results available at the same time as PD-L1 as recommended by the NCCN guidelines.1

Insufficient samples are a persistent problem in lung cancer genomic profiling resulting in a high invalid/ rejection rate. IdyllaTM EGFR only requires 1 tissue section (5-10 µm) per assay and shows a significant lower invalid rate compared to other methods.

IdyllaTM EGFR Mutation Test

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Idylla GeneFusion Panel

The Idylla™ GeneFusion Panel detects ALK, ROS1 and RET rearrangements and METex14 skipping alterations in one single cartridge, a wide range of actionable targets relevant in non-small cell lung cancer (NSCLC). Designed for use in clinical laboratories, the Panel provides comprehensive testing results within 180 minutes, significantly faster than currently available testing methods which often take days or even weeks before results are available.

Moreover, the Idylla™ GeneFusion Panel only requires a limited amount of sample, thereby saving valuable tissue specimens. The Panel demonstrated high concordance results in a clinical comparison study where ALK was compared with IHC and ROS1, RET and METex14 skipping were compared with NGS.1

Idylla GeneFusion Panel

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  • 1Data obtained from the clinical performance evaluation performed by Biocartis in view of the CE-marking. The clinical performance evaluation compared the Idylla™ GeneFusion Panel with IHC (VENTANA ALK (D5F3) Assay, Roche Diagnostics GmbH) for ALK; ROS1, RET and METex14 skipping were evaluated versus NGS (Oncomine™ Focus Assay, Thermo Fisher Scientific)
Idylla GeneFusion Panel Cartridge

Testimonial

Today, EGFR testing is a cumbersome process and it often takes several weeks before results are analyzed. This may lead to the administration of anti-EGFR therapy as second-line agents, which is less efficient than their use in first-line therapy. The IdyllaTM EGFR Mutation Test technology has the potential to change that: it is a cost-effective solution, ensuring reliable and fast detection of all relevant mutations

  • Prof Giancarlo Troncone

  • University of Napoli Federico II, Naples, Italy 

Prof Troncone