COBAS EGFR MUTATION TEST PDF

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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SQI showed a positive correlation with mutant allele frequency derived from digital droplet PCR measurements.

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

Plasma EGFR genotyping methods by laboratories participating in pilot external quality assurance. Comparison of mutant allelic frequency from two laboratories using different next-generation sequencing platforms.

The precision of SQI is summarized in Table 4. Unacceptable response rate in pilot external quality assurance scheme.

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

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 ].

In the era of companion diagnostics, more mutations will be used as predictive markers to determine patient eligibility for molecular-targeted therapies. Previous studies reported that it is challenging to detect the p. Molecular testing of EGFR is required to predict the response likelihood to targeted therapy in non-small cell lung cancer.

Using NGS, eggr e.

A month after mutaion the EQA materials, all results were emailed from each laboratory to an organizing director.

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Materials and Methods 2. Thus, this assay can be used for rapid and reliable plasma ctDNA analysis in clinical diagnostic laboratories. Fourteen laboratories received two identical panels of 27 single-blinded plasma samples. LeuArg variants for the lowest target copies. Correspondence should be addressed to Kyung-A Lee ; ca.

Individual laboratories should optimize NGS performance to maximize clinical utility.

TM and exon 20 insertion mutations were not detected in LOD level 4 material by any of the laboratories. It was unclear whether unacceptable responses were due to the performance of specific NGS methods or the laboratory. For the cobas assay, the mean, standard deviation, coefficient of variation CVmedian value, minimum value, and maximum value of data from egtr peer group and the standard deviation index of the data from the laboratory were provided in the evaluation reports.

Jutation results from the cobas assay were positively correlated with allele frequencies derived from digital droplet PCR measurements and showed good reproducibility among laboratories. To receive news and publication updates for BioMed Research International, enter your email address in the box below. The cobas assay showed reliable mutstion robust test performance in all laboratories.

In our pilot EQA, the cobas assay showed a higher detection rate and lower imprecision for exon 19 deletion and p. 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.

Details are provided in Supplementary Table S2. NGS generally requires more time than IVD, although it differs depending on batch constitution and the platform used. 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.

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 ]. These test samples had expected mutant allele frequencies of 3. 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.

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LR HDand p. Prediction models revealed a significant correlation for all variants between the predefined copy number and the observed semiquantitative index values, which reflect the samples’ plasma mutation load. There was sufficient coverage at all target mutations to detect variants with allele frequencies of 0. All specificities were TM and 70,X for p. LOD level 4 material, which had an expected mutant allele frequency of 0. Therefore, highly sensitive methodologies have been developed to detect low abundance epidermal growth factor receptor EGFR mutations, including p.

TM mutation in relapsed tumors because of tumor heterogeneity [ 6 ]. The analytical sensitivities of the cobas assay were not identical for the different target mutations, similar to previous reports [ 1415 ].

Abstract Liquid biopsies to genotype the epidermal sgfr 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. Introduction 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 ].

Preparation of EQA Materials 2.