Dataset Information

Comparison of the analytical performance between the Oncomine Dx Target Test and a conventional single gene test for epidermal growth factor receptor mutation in non-small cell lung cancer.

ABSTRACT:

Background

Next-generation sequencing (NGS) has been implemented in clinical oncology to analyze multiple genes and to guide targeted therapy; however, little is known about the performance of the Oncomine Dx Target Test compared with conventional single gene tests for detecting EGFR mutations. The objective of this study was to evaluate the performance of the Oncomine Dx Target Test compared with a PNA-LNA PCR clamp test to detect EGFR mutations.

Methods

We retrospectively reviewed consecutive patients with non-small cell lung cancer (NSCLC) from whom FFPE samples were simultaneously submitted for the Oncomine Dx Target Test, and a PNA-LNA PCR clamp test using the same specimen. We subsequently compared the analysis success rates and detection rates between the two tests.

Results

A total of 116 samples were identified. The success rates and detection rates of EGFR mutations in the total number of samples were 90% and 28%, respectively for the Oncomine Dx Target Test, and 100% and 35% for the PNA-LNA PCR clamp test. The Oncomine Dx Target Test was unable to analyze three samples (2%) due to the samples not passing the nucleic acid concentration threshold, and nine (8%) samples had invalid results. The exon 19 deletion was not detected by the Oncomine Dx Target Test in four cases (4%).

Conclusions

The analytical performance of the Oncomine Dx Target Test analysis for EGFR mutations may not be comparable with conventional single gene tests due to both invalid and false-negative results.

Key points

Significant findings of the study The success rate of the Oncomine Dx Target Test was significantly lower than the PNA-LNA PCR clamp test. Among the samples successfully analyzed, four exon 19 deletions were not detected by the Oncomine Dx Target Test. What this study adds The analytical performance of the Oncomine Dx Target Test may not be comparable with conventional single gene tests. We should revise the sampling procedures, and review the sample quality assessment methods, to improve the analytical performance.

SUBMITTER: Sakaguchi T

PROVIDER: S-EPMC7882374 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Comparison of the analytical performance between the Oncomine Dx Target Test and a conventional single gene test for epidermal growth factor receptor mutation in non-small cell lung cancer.

Sakaguchi Tadashi T Iketani Akemi A Furuhashi Kazuki K Nakamura Yuki Y Suzuki Yuta Y Ito Kentaro K Fujiwara Kentaro K Nishii Yoichi Y Katsuta Koji K Taguchi Osamu O Hataji Osamu O

Thoracic cancer 20201212 4

<h4>Background</h4>Next-generation sequencing (NGS) has been implemented in clinical oncology to analyze multiple genes and to guide targeted therapy; however, little is known about the performance of the Oncomine Dx Target Test compared with conventional single gene tests for detecting EGFR mutations. The objective of this study was to evaluate the performance of the Oncomine Dx Target Test compared with a PNA-LNA PCR clamp test to detect EGFR mutations.<h4>Methods</h4>We retrospectively review ...[more]

PMID: 33314600

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Project description:BackgroundThe Oncomine Dx Target Test (ODxTT) is a next-generation sequencing-based companion diagnostic test which has been recently developed; however, its analysis success rate could be improved, especially for small samples. The aim of this study was to identify the pathological factors associated with biopsy specimens that affect the analysis success rate of ODxTT.MethodsWe retrospectively investigated 119 cases subjected to ODxTT at Kanagawa Cancer Center. Data pertaining to the results of BRAF V600E mutation analysis in ODxTT and pathological factors based on microscope slides were collected. Pathological factors including tissue surface area, tumor cell count, and tumor content rate were assessed. We constructed receiver operating characteristic curves and determined the optimal cutoff values of each pathological factor. Multivariate logistic analysis was used to identify significant factors.ResultsA total of 98 of 119 samples were successfully analyzed (75.6%). The tissue surface area and tumor cell count were significantly higher in the group associated with analysis success (P?<?0.001 and P = 0.011, respectively), and their optimal cutoff values were 1.04?mm2 and 375 cells, respectively. A tissue surface area?>?1.04?mm2 and tumor cell count >375 cells had a positive effect on the analysis success rate of ODxTT (odds ratio [OR] 0.10; 95% confidence interval [CI]: 0.03-0.35; P?<?0.001 and OR 0.25; 95% CI: 0.07-0.90; P = 0.033, respectively).ConclusionsSelecting samples with a tissue surface area?>?1.04?mm2 and a tumor cell count >375 cells might improve the analysis success rate of ODxTT.Key pointsSignificant findings of the study: We found that a tissue surface area?>?1.04?mm2 and tumor cell count >375 cells had a positive effect on the analysis success rate of ODxTT in the analysis of biopsy tissue samples.What this study addsIt is sometimes necessary to assess genetic alterations with a small biopsy sample in daily practice. The criteria mentioned above will help to determine which tests should be performed, ODxTT or multiple single-gene testing.

Dataset Information

Comparison of the analytical performance between the Oncomine Dx Target Test and a conventional single gene test for epidermal growth factor receptor mutation in non-small cell lung cancer.

Background

Methods

Results

Conclusions

Key points

Publications

Comparison of the analytical performance between the Oncomine Dx Target Test and a conventional single gene test for epidermal growth factor receptor mutation in non-small cell lung cancer.

Similar Datasets

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