Here we review one of these companion tests, the Roche cobas® EGFR mutation test v2, from a methodological point of view, also exploring its. “The cobas® EGFR Mutation Test v2 is a companion diagnostic test that supports IRESSA® as an additional therapeutic option for patients and. The U.S. Food and Drug Administration (FDA) recently approved the cobas EGFR Mutation Test v2 as a companion diagnostic test with gefitinib.

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CS resistance mutation [ 20 ] or novel mutations in EGFRas well as other genes, can be identified [ 21 ].

This is an open access article distributed under the Creative Commons Attribution Licensewhich permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Thus, this assay can be used for rapid and reliable plasma ctDNA analysis in clinical diagnostic laboratories. Therefore, caution is warranted in the setting of tumor relapse, and additional efforts should be made to optimize the experimental conditions to increase the sensitivity of p.

Our data and previous reports indicate that high coverage depth is essential to improve the detection of low-level targets [ 1819 ]. Plasma EGFR genotyping methods by laboratories participating in pilot external quality assurance.

cobzs This finding is consistent with that of a previous study that evaluated clinical samples with NGS and the cobas assay [ 13 ]. Torrent Suite software provides molecular coverage depth as well as read coverage depth at target bases to increase detection sensitivity for low-frequency variants [ 1112 ]. Details are provided in Supplementary Table S1.


Therefore, highly sensitive methodologies have been developed to detect low abundance epidermal growth factor receptor EGFR mutations, including p. TM HDp. Previous studies reported that it is challenging to detect the p.

SQI showed a positive correlation mjtation mutant allele frequency derived from digital droplet PCR measurements. For all mutations, SQI values from the cobas assay exhibited a strong positive correlation with the expected mutant allele frequencies derived from digital droplet PCR measurements Spearman rank-correlation coefficient, 0. Seven of nine cobas assays None of the four target mutations were detected in level 4 material.

Recently, Haselmann et al. In Juneevaluation reports were distributed to participating laboratories. All eight measurements of Test 4 material detected the exon 19 deletion.

This difference in assay performance according to target mutation might be due to the assay design and characteristics of the target regions [ 1415 ]. In the era of companion diagnostics, more mutations will be used as predictive markers to determine patient eligibility for molecular-targeted therapies.

Analytical performance of the cobas EGFR mutation assay for Japanese non-small-cell lung cancer.

TM and 70,X for p. Using NGS, rare e. For all other variants, sensitivities varied between In our pilot EQA, the cobas assay showed a higher detection rate and lower imprecision for exon 19 deletion and p. We performed a pilot external quality assurance EQA scheme to harmonize circulating tumor DNA testing among laboratories.

Analytical performance of the cobas EGFR mutation assay for Japanese non-small-cell lung cancer.

To receive news and publication updates for BioMed Research International, enter your email address in the box below. Larger trial including more genotyping platforms including digital PCR with our sample preparation protocol is worthy of further investigation.


In AprilEQA materials were made and distributed to each laboratory. All results obtained using the cobas assay were concordant except for detection of EGFR exon 19 deletion and p. Correspondence should be addressed to Kyung-A Lee ; ca. Comparison of umtation allelic frequency from two laboratories using different next-generation sequencing platforms. Coefficients egfrr variation indicated good intralaboratory and interlaboratory repeatability and reproducibility but increased for decreasing concentrations.

Abstract Liquid biopsies to genotype the epidermal growth factor receptor EGFR for targeted therapy have been implemented in clinical decision-making in the field of lung cancer, but harmonization of detection methods is still scarce among clinical laboratories.

The cobas® EGFR Mutation Test

NGS generally requires more time than IVD, although it differs depending on batch constitution and the platform used. Data were mutatuon by the cobas z software if positive and negative controls showed valid results.

Copy numbers and frequencies of mutant alleles are provided in Supplementary Table S3. LR in LOD level 4 material.

Dots in the figure represent negative measurement ND or the SQI value of the positive measurement for a p. External quality assessment EQA is a way to standardize interlaboratory results and to monitor and improve testing processes across laboratories [ 10 ].