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Performance of a new system using a one-step nucleic acid amplification assay for detecting lymph node metastases in breast cancer

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Abstract

One-step nucleic acid amplification (OSNA) for CK19 mRNA is an intraoperative diagnostic procedure for detection of lymph node metastasis. Automated Gene Amplification Detector RD-200 and the LYNOAMP CK19 gene amplification reagent as components of a new OSNA system have been developed. As an improvement over a conventional system, the new system can analyze 14 samples per run, evaluate two lymph nodes in ~ 17 min, and reduce inhibition of reactions. This study was aimed at evaluating clinical performance of the new system by comparing it with performance of histopathological analysis and a conventional OSNA system. A total of 150 lymph nodes in 63 breast cancer patients (T1–3) who underwent sentinel lymph node biopsy or axillary lymph node dissection were examined intraoperatively with the new OSNA system, the conventional system, and histopathological analysis. In comparison with histopathological analysis, sensitivity, specificity, and concordance rate of the new system were 93.9, 98.8, and 96.7%, respectively. In comparison with the conventional system, similar corresponding values were obtained: 96.9, 98.8, and 98.0%, respectively. The results show that clinical performance of the new OSNA system is equivalent to that of histopathological diagnosis and the conventional OSNA system. The new system is superior to the conventional one because of processing of a greater number of samples, shorter testing time, and the absence of inhibited reactions.

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Funding

All the funding was provided by the Sysmex Corporation.

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Authors and Affiliations

  1. Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2-E10 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan

    Kenzo Shimazu, Tomonori Tanei & Shinzaburo Noguchi

  2. Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan

    Yasuhiro Tamaki

  3. Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan

    Toshiaki Saeki, Akihiko Osaki & Takahiro Hasebe

  4. Department of Pathology, International University of Health and Welfare, Chiba, Japan

    Yasuhiko Tomita

  5. Gene Testing Business, Sysmex Corporation, Kobe, Japan

    Motonari Daito & Mayuko Kobayashi

Authors
  1. Kenzo Shimazu
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  2. Tomonori Tanei
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  3. Yasuhiro Tamaki
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  4. Toshiaki Saeki
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  5. Akihiko Osaki
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  6. Takahiro Hasebe
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  7. Yasuhiko Tomita
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  8. Motonari Daito
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  9. Mayuko Kobayashi
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  10. Shinzaburo Noguchi
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Corresponding author

Correspondence to Kenzo Shimazu.

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Conflict of interest

KS. has received honoraria from AstraZeneca, Novartis and Sysmex. Y.T. has received honoraria from AstraZeneca, Eisai, Pfizer, Allergan, Johnson & Johnson. T.S and A.O. have received research funding AstraZeneca, Eisai, Ono, Kyowa Hakko, Daiichi-Sankyo, Taiho, Chugai, Nippon Kayaku, Bayer, MSD, Nihon-Mediphysics, Hamamatsu-photonics and Parexel on the other studies. S.N. has been an advisor for AstraZeneca, Novartis and Taiho, has received honoraria from Sysmex, AstraZeneca, Chugai, Nippon Kayaku, Novartis and Takeda, and has received research funding from Sysmex, AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Nippon Kayaku, Novartis, Ono, Pfizer, Taiho and Takeda on the other studies. S.N. hold the joint patents with Sysmex on subjects not related to this study. M.D. and M.K. are employees of Sysmex Corporation. The other Authors do not declare any conflict of interest related to this study.

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The study protocol was approved by the institutional review boards of all participating institutions.

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Informed consent was obtained from all patients included in the study.

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Shimazu, K., Tanei, T., Tamaki, Y. et al. Performance of a new system using a one-step nucleic acid amplification assay for detecting lymph node metastases in breast cancer. Med Oncol 36, 54 (2019). https://doi.org/10.1007/s12032-019-1277-x

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  • DOI: https://doi.org/10.1007/s12032-019-1277-x

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