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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BioMed Research International

This finding is an important issue for detection of p. However, coverage depth results from two laboratories indicate that more read coverage depth is required to detect low-frequency variants in samples. Prediction models may be applied to estimate the plasma mutation load egr diagnostic or research purposes. LOD level 4 material, which had an expected mutant allele frequency of 0. Larger trial including more genotyping platforms including digital PCR with our sample preparation protocol is worthy of further investigation.

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

Individual laboratories should optimize NGS performance to maximize clinical utility. Indexed in Science Citation Index Expanded. Each laboratory director requested the amount of EQA material needed according to the number of methods planned for plasma EGFR testing.

The analytical sensitivities of the cobas assay were not identical for the different target mutations, similar to previous reports [ 1415 ].

The precision of SQI is summarized in Table 4. Copy numbers and frequencies of mutant alleles are provided in Supplementary Table S3. Tes data and previous reports indicate that high coverage depth is essential to improve the detection of low-level targets [ 1819 ].

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Results from two laboratories were consistent with the expected mutant allele frequencies calculated from absolute allele frequencies measured using digital droplet PCR. All specificities were External quality assessment EQA is a way to standardize interlaboratory results and to monitor and improve testing processes fest laboratories [ 10 ].

TM and exon 20 insertion. 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, mutattion the metastatic potential of the cancer cells [ 2 ]. Materials and Methods 2. Submitted qualitative xobas 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 cobas® EGFR Mutation Test

The workflow of the study process is shown in Supplementary Figure S1. 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.

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 ]. In the present study, we confirmed the LODs of the ehfr assay for each target mutation.

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Table of Contents Alerts.

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

TM HDp. From November to Juneseven clinical conas laboratories participated in the EQA program. Unacceptable response rate in pilot external quality assurance scheme. TM mutation in relapsed tumors because of tumor heterogeneity [ 6 ]. LR HDand p. Exon 19 deletion and exon 20 insertion mutations were detected at 0.

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 ].

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.

Tumor-derived ctDNA often represents a small percentage of the total cfDNA and can be present at allele fractions as low as 0. For the cobas assay, the mean, standard deviation, coefficient of variation CVmedian value, minimum value, and maximum value of data from the peer group and the standard deviation index of the data from the laboratory were provided in the evaluation reports.

Cobzs of variation indicated good intralaboratory and interlaboratory repeatability and reproducibility but increased for decreasing concentrations.