Press Release

Sysmex Becomes the First in Japan1 to Realize Automated Detection of Lymph Node Metastasis of Non-Small-Cell Lung Cancer

- Application of the OSNA® Method Expanded to Include Non-Small-Cell Lung Cancer, Following Application for Breast Cancer, Colorectal Cancer and Stomach Cancer -

  Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces its receipt on November 4, 2015, from the Ministry of Health, Labour and Welfare, of manufacturing and marketing approval for an expanded application of its LYNOAMP BC diagnostic reagent to the detection of lymph node metastasis of non-small-cell lung cancer. The reagent is already being marketed for use in the detection of lymph node metastasis of breast, colorectal and stomach cancer.

  Each year, throughout the world approximately 1.82 million people are said to be affected by lung cancer2. Japan accounts for approximately 130,000 of these patients, and the rate of death from this type of cancer tops the list for men, while it is the second leading cancer-related death for women, following colorectal cancer3.
  Depending on histological type, lung cancer is broadly divided into non-small-cell lung cancer and small-cell lung cancer. Non-small-cell lung cancer accounts for some 85% of lung cancer cases4. During treatment for non-small-cell lung cancer, the existence of lymph node metastasis and the location and number of metastases are one determinant of the cancer's progression. Knowing this information can help a physician decide on treatment methods, such as whether to excise a portion of the lung or to use anti-cancer agents. 
  Sysmex introduced an automated lymph-node metastasis rapid detection system5 for breast cancer in 2008. Highly praised for its ability to detect metastasis in around only 30 minutes, Sysmex’s system has been adopted globally by many institutions, particularly in regions such as Japan and Europe. In Japan, the method received a recommendation in the Japanese Breast Cancer Society’s Clinical Practice Guideline for Breast Cancer, Fiscal 2013 Edition6 as one of the detection methods of metastasis in sentinel lymph nodes, contribute to standardization the rapid detection of breast cancer lymph node metastasis. 
  Sysmex also automated the rapid detection of lymph node metastasis for colorectal cancer in 2010 and stomach cancer in 2012. 
  Having received approval to extend application of the rapid detection of lymph node metastasis to non-small-cell lung cancer, it will become possible to determine the existence of lymph node metastasis of this cancer by employing the same reagents and instruments as are currently used for breast cancer, colorectal cancer and stomach cancer. 
  The lymph node metastasis rapid detection system using the OSNA method7 developed by Sysmex shortens the time required to obtain results from the detection of lymph node metastasis, raises the precision of detection of non-small-cell lung cancer lymph node metastasis, and is expected to contribute to the determination of more appropriate treatment methods. 
  Going forward, Sysmex will strive to expand the global market for lymph node metastasis rapid detection systems that employ the OSNA method, and work toward standardizing the detection of lymph node metastasis of cancer.
1 Based on Sysmex’s research
2 Source: GLOBOCAN 2012
3 Source:
Cancer Statistics ’14, Foundation for Promotion of Cancer Research
4 Source:
More of What You Should Know about Lung Cancer, 2014 Edition, Cancer Net Japan 
5 Lymph node metastasis rapid detection system:
This diagnostic testing system comprises our RD-100i gene amplification detector-a specialized automated analyzer-and the LYNOAMP BC gene amplification reagent, for which the extended scope of application has been approved. 
6 Clinical Practice Guideline for Breast Cancer, Fiscal 2013 Edition:
  These are guidelines formulated by the Japanese Breast Cancer Society for physicians to refer to when treating breast cancer. The guidelines cover five areas: drug therapy methods, surgical treatment methods, radiation therapy methods, screening and diagnosis, and epidemiology and prevention. The guidelines are revised every three years. 
7 OSNA method: Abbreviation for One-Step Nucleic acid Amplification, a method developed by Sysmex. This enables metastasis of a single lymph node to be determined in approximately 30 minutes.
  • Information contained in the press release is current as of the date of the announcement,
    but may be subject to change without prior notice.

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