Targeted Assessment of the EGFR Status as Reflex Testing in Treatment-Naive Non-Squamous Cell Lung Carcinoma Patients: A Single Laboratory Experience (LPCE, Nice, France)

Abstract

Background: Assessment of actionable EGFR mutations is mandatory for treatment-naïve advanced or metastatic non-squamous lung carcinoma (NSLC), but the results need to be obtained in less than 10 working days. For rapid EGFR testing, an EGFR-specific polymerase chain reaction (PCR) assay is an alternative and simple approach compared to next generation sequencing (NGS). Here, we describe how a rapid EGFR-specific PCR assay can be implemented in a single laboratory center (LPCE, Nice, France) as reflex testing in treatment-naïve NSLC. Methods: A total of 901 biopsies from NSLC with more than 10% of tumor cells were prospectively and consecutively evaluated for EGFR mutation status between November 2017 and December 2019 using the Idylla system (Biocartis NV, Mechelen, Belgium). NGS was performed for nonsmokers with NSLC wild type for EGFR, ALK, ROS1, and BRAF and with less than 50% PD-L1 positive cells using the Hotspot panel (Thermo Fisher Scientific, Waltham, MA, USA). Results: Results were obtained from 889/901 (97%) biopsies with detection of EGFR mutations in 114/889 (13%) cases using the Idylla system. Among the 562 EGFR wild type tumors identified with Idylla, NGS detected one actionable and one nonactionable EGFR mutation. Conclusions: Rapid and targeted assessment of EGFR mutations in treatment-naïve NSLC can be implemented in routine clinical practice. However, it is mandatory to integrate this approach into a molecular algorithm that allows evaluation of potentially actionable genomic alterations other than EGFR mutations.

A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy

“…The results of the present study demonstrated 100% sensitivity and specificity with the Idylla SARS-CoV-2 Test compared with two of the defined SOC tests used in the Nice area. Moreover, cross validation between two laboratories (CHU of Nice and the Naples Hospital) of Idylla platforms showed high concordance with negative and positive SARS-CoV-2 samples (16)(17)(18)(19).…”

What Is New in Biomarker Testing at Diagnosis of Advanced Non-Squamous Non-Small Cell Lung Carcinoma? Implications for Cytology and Liquid Biopsy

“…These genomic alterations are detectable on cytological samples and in liquid biopsies (LB) and are certainly the first mutations that are looked for in routine clinical practice for patients in care [63]. In this regard, many targeted sequencing methods, allowing for results in a short amount of time from cytological or blood specimens, have been used in many hospitals [64][65][66]. More recently, NGS methods have developed from these specimens, notably for EGFR status evaluation at baseline [67].…”

EGFR Status Assessment for Better Care of Early Stage Non-Small Cell Lung Carcinoma: What Is Changing in the Daily Practice of Pathologists?

“…The evaluation of mutations in EGFR can be performed by targeted sequencing or by "next generation sequencing" (NGS) (Figure 2A,B). The use of an NGS type of approach by most of the clinical trials (for example the ADAURA trial) that target only the L858R mutation and the exon 19 deletion in EGFR thus seems unnecessary since this evaluation can be done by presently commercialized RT-PCR tests, notably those developed within laboratories [66,67]. Rapid tests such as those proposed by Biocartis (Mechelen, Belgium) with the Idylla approach or by Roche Diagnostics (Basel, Switzerland) using the COBAS approach can be adapted, too [66][67][68].…”

“…The use of an NGS type of approach by most of the clinical trials (for example the ADAURA trial) that target only the L858R mutation and the exon 19 deletion in EGFR thus seems unnecessary since this evaluation can be done by presently commercialized RT-PCR tests, notably those developed within laboratories [66,67]. Rapid tests such as those proposed by Biocartis (Mechelen, Belgium) with the Idylla approach or by Roche Diagnostics (Basel, Switzerland) using the COBAS approach can be adapted, too [66][67][68]. These latter tests can detect a large number of mutations in EGFR, beyond the L858R mutation and the exon 19 deletion [62,67].…”