On October 12, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported the approval, as of October 7, 2022, of an application for a partial change to the manufacturing and marketing approval in Japan of its gene amplification reagent LYNOAMP CK19 marketed as a lymph node metastasis test reagent for breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, expanding its amplification to cervical cancer and endometrial cancer (Press release, Sysmex, OCT 12, 2022, View Source [SID1234621932]).

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Whether lymph node metastasis has occurred is an indicator of cancer progression during treatment for cervical cancer and endometrial cancer. Lymph node metastasis testing plays an important role in forming a medical treatment plan such as operating procedures and post-operative adjuvant therapy.

This testing is typically performed during or after surgery when a pathologist prepares samples from surgically removed lymph nodes, and then views the samples under a microscope to determine whether the cancer cells have metastasized. However, the test places a heavy workload on pathologists. Combined with a shortage of pathologists, this type of testing presents problems in medical settings.

Sysmex has employed its proprietary technology, the OSNA method,1 in rapidly detecting cancer lymph node metastasis, using its a gene amplification detector RD-100i and the reagent LYNOAMP BC, and has marketed them in in Japan since 2008. After gaining manufacturing and marketing approval for breast cancer in the same year, Sysmex strove to expand the system to further cancer types. In 2018, Sysmex launched the gene amplification detector RD-200 and the reagent LYNOAMP CK19, which shortens the testing process while increasing the number of samples that can be tested simultaneously. This has been approved by the national health insurance in Japan as the only lymph node metastasis testing system that adopts a molecular biological technique.

The system automates and simplifies cancer lymph node metastasis testing, and provides objective test results without relying on the examiner’s proficiency. This reduces the workload on pathologists and contributes to the equalization of medical care2 and the formulation of medical treatment plans, taking into account the burden on patients and their QOL.

Sysmex has now gained approval for a partial change to expand the application of LYNOAMP CK19, currently used as a lymph node metastasis test reagent for breast cancer, colorectal cancer, gastric cancer and non-small cell lung cancer, to cervical cancer and endometrial cancer. Through the provision of rapid and accurate results in lymph node metastasis testing, the system is expected to contribute to the formulation of appropriate medical treatment plans for patients with cervical or endometrial cancer.

Sysmex will continue working toward the further rollout of testing of lymph node metastasis using the OSNA method, contributing to the standardization of healthcare and improvement of patients’ QOL.