Press Release

Insurance Coverage of Lymph Node Metastasis Testing for Non-Small-Cell Lung Cancer Using the OSNA™ Method

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces that lymph node metastasis testing for non-small-cell lung cancer using the OSNA™ method, which Sysmex developed, is covered by insurance effective October 1, 2017.

Lymph node metastasis testing of cancer patients is typically performed during or after surgery when a pathologist prepares pathological samples from surgically removed lymph nodes and then views the samples under a microscope to determine whether cancer cells have metastasized (histopathological examination). However, this testing places a major work burden on pathologists, and the medical arena is plagued by a shortage of pathologists.

Sysmex has succeeded in using the One-Step Nucleic Acid Amplification (OSNA™) method, a technology that Sysmex developed, in a lymph node metastasis testing system that automates the detection of lymph node metastasis. We have worked to increase the types of cancer to which this testing can be applied. In November 2008, the use of the OSNA™ method for lymph node metastasis testing was covered under Japan’s national health insurance for breast cancer. In October 2013, coverage was expanded to include colorectal cancer and stomach cancer. 

Employing the OSNA™ method, the lymph node metastasis testing system uses the RD-100i gene amplification detector and LYNOAMP™ BC gene amplification reagent, allowing metastasis to be determined automatically in approximately 30 minutes, to at least the same level of precision as a histopathological examination using a permanent preparation1. This system is already used in routine testing at more than 100 healthcare institutions in Japan and more than 200 overseas. 

In addition to breast cancer, colorectal cancer and stomach cancer, lymph node metastasis testing using the OSNA™ method for non-small-cell lung cancer is now covered by Japan’s national health insurance.

As the provision of lymph node metastasis testing using the OSNA™ method for non-small-cell lung cancer enables highly precise intra-operative detection of metastasis to regional lymph nodes2, it allows for selective lymph node dissection3, reduces the dissection range and permits the selection of minimum lung resection ranges on patients. This helps reduce unnecessary lung resection and lymph node dissection, thereby lowering the likelihood of patients experiencing post-operative complications and a decrease in respiratory function, and shortening the hospitalization period, reducing the burden on patients and contributing to their quality of life. 

Going forward, Sysmex will work toward the further expansion of the global market for lymph node metastasis testing using the OSNA™ method, the standardization of lymph node metastasis testing and the development of personalized medicine. 


Outline of Insurance Coverage
Measurement parameter: Cytokeratin 19 (KRT19) mRNA
Measurement method: OSNA™ method
Main purpose of measurement: Detection of cytokeratin 19 (KRT19) mRNA in the regional lymph node of excised non-small-cell lung cancer (assist in the diagnosis of lymph node metastasis of non-small-cell lung cancer)
NHI points: 2,400 (limited to once per course of treatment)
1 Permanent preparation:
A sample of tissue excised during surgery that is fixed in formalin and used in the definitive post-operative diagnosis of cancer. Enables more accurate diagnosis than rapid intra-operative diagnosis using frozen samples. 
2 Regional lymph node:
Lymph node located near cancer that has a higher likelihood of cancer metastasis than other lymph nodes. 
3 Lymph node dissection:
Resection during surgery of a lymph node that is likely to have metastasized cancer, in order to curtail cancer recurrence.

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    but may be subject to change without prior notice.

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