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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Our data and previous tsst indicate that high coverage depth is essential to improve the detection of low-level targets [ 1819 ]. Using NGS, rare e.

LeuArg variants for the lowest target copies. Coefficients of variation indicated good intralaboratory and interlaboratory repeatability and reproducibility but increased for decreasing concentrations. For the cobas assay, the mean, standard deviation, coefficient of variation CVmedian value, minimum value, and maximum value of data from the peer egrf and the standard deviation index of the kutation from the laboratory were provided in the evaluation reports.

Individual laboratories should optimize NGS performance to maximize clinical utility. TM testing included pyrosequencing, digital PCR, and several allele-specific PCR platforms, using four levels of spiked materials [ 25 ].

Data were interpreted by the cobas z software if positive and negative controls showed valid results. Molecular testing of EGFR is required to predict the response likelihood to targeted therapy in non-small cell lung cancer.

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. From November to Juneseven clinical diagnostic laboratories participated in the EQA program. Careful interpretation is particularly important for p.

Plasma EGFR genotyping methods by laboratories participating in pilot external quality assurance. The workflow of the study process is shown in Supplementary Figure S1. Indexed in Science Citation Index Expanded. In AprilEQA materials were made and distributed to each laboratory. In Juneevaluation reports were distributed to participating laboratories. There was sufficient coverage at all target mutations to detect variants with allele frequencies of 0.


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

In our pilot EQA, the cobas assay showed a higher detection rate and lower imprecision for exon 19 deletion and p. LR HDand p. Circulating tumor DNA ctDNA carries the 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 ].

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. Amplification and detection were performed using the cobas z analyzer Roche Molecular Systems, Inc. LR in LOD level 4 material.

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

All results obtained using the cobas assay were concordant except for detection of EGFR exon 19 deletion and p. The analytical sensitivities of the cobas assay were not identical for the different target mutations, similar to previous reports [ 1415 ]. EQA is critical for quality assurance and continuous improvement of individual laboratory performance [ 9 ]. Each laboratory director requested the amount of EQA material needed according to mutatoon number of methods planned for plasma EGFR testing.

The number of reactions per test method among participating laboratories was LR detection rate Analysis of circulating tumor DNA in plasma may complement limitations of tumor coobas. Correlations between SQI from cobas assay and mutant allele frequency were analyzed using Spearman rank-correlation test.



BioMed Research International

Thus, this assay can be used for rapid and reliable plasma ctDNA analysis in clinical diagnostic laboratories. TM and exon 20 insertion. This finding is an important issue for detection of p. The cobas assay showed reliable and robust test performance in all laboratories.

The precision of SQI is summarized in Table 4.

The cobas® EGFR Mutation Test

To receive news and publication updates for BioMed Research International, enter your email address in the box below. These test samples had expected mutant allele frequencies of 3.

Larger trial including more genotyping platforms including digital PCR with our sample preparation protocol is worthy of further investigation.

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. The authors declare that there are no conflicts of interest regarding the publication of mutatiin paper.

Therefore, SQI could be useful for patient monitoring. Prediction models may be applied to estimate the plasma mutation load for diagnostic or research purposes. Details are provided in Supplementary Table S1. We performed a pilot external quality assurance EQA scheme to harmonize circulating tumor DNA testing among laboratories. Unacceptable response rate in pilot external quality assurance scheme.

Therefore, highly sensitive methodologies have been developed to detect low abundance epidermal growth factor receptor EGFR mutations, including p. All values were two-sided, and values less than 0. All targeted mutations were called in levels 1—4 materials at similar allele frequencies to what were expected.