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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Molecular testing of EGFR is required to predict the response likelihood to targeted therapy in non-small cell lung cancer.

Mutant allele frequencies were calculated from the submitted depth of coverage data from NGS Table 5.

TM and exon 20 insertion mutations were not detected in LOD level 4 material by any of the laboratories. The fraction of tumor-derived cell-free DNA cfDNA in blood plasma varies according to tumor stage, tumor burden, vascularization of the tumor, biological features of the tumor such as apoptotic rate, and the metastatic potential of the cancer cells [ 2 ].

BioMed Research International

LR HDand p. It was unclear whether unacceptable responses were due to the performance of specific NGS methods or the laboratory. Fourteen laboratories received two identical panels of 27 single-blinded plasma samples.

Circulating tumor DNA ctDNA carries kutation same molecular alterations as the tumor itself and can be used to select treatment, assess the emergence of drug resistance, and monitor lung cancer patients in routine clinical practice [ 1 ]. In a deep sequencing run, all four quality control samples were sequenced with high median coverage depth of more than 86,X.


To ensure optimal quality molecular testing, clinical laboratories should evaluate the technical performance of ctDNA testing according to the standards from formal accreditation bodies, such as Clinical Laboratory Improvement Amendments CLIA and ISO [ 89 ].

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

This finding is an important issue for detection of p. The analytical sensitivities of the cobas assay were not identical for the different target mutations, similar to previous reports [ 1415 ]. TM, and d p. All results obtained using the cobas assay were concordant except for detection of EGFR exon 19 deletion and p.

Unacceptable response rate in pilot external quality assurance scheme. This difference in assay performance according to target mutation might be due to the assay design and characteristics of the target regions [ 1415 ]. As a result, rigorous quality controls to avoid inappropriate patient treatment will become increasingly important in clinical diagnostic laboratories.

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. Comparison of mutant allelic frequency from two laboratories using different next-generation sequencing platforms.

LR in LOD level 4 material. LR than for ehfr.

TM and 70,X for p. 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.

Seven of nine cobas assays We performed a pilot external quality assurance EQA scheme to harmonize circulating tumor DNA testing among laboratories. LOD level 4 material, which had an expected mutant allele frequency of 0. In the present study, we confirmed the LODs of the cobas assay for each target mutation.


All specificities were LR mutations were not detected, despite the fact that total read coverage depth was not lower for these loci than other loci 65,X for p. Indexed in Science Citation Index Expanded.

The cobas® EGFR Mutation Test

Thus, this assay can be used for rapid and reliable plasma ctDNA analysis in clinical diagnostic teest. LeuArg variants for the lowest target copies. In Juneevaluation reports were distributed to participating laboratories.

Previous studies reported that it is challenging to detect the p. When a mutation was detected, semiquantitative index SQI values for each mutation are reported automatically by the software using the observed threshold cycle for the target mutation. Submitted qualitative results were evaluated as acceptable positive for expected mutations or negative for unexpected mutations or unacceptable negative for expected mutations or positive for unexpected mutationsaccording to the manufactured and validated target mutations in this study Table 1 and Supplementary Table S2.

In AprilEQA materials were made and distributed to each laboratory. Preparation of EQA Materials 2. All eight measurements of Test 4 material detected the exon 19 deletion.

Careful interpretation is particularly important for p.