News
News
Cancer Lymph Node Metastasis Test System Using the OSNA™ Method Expanded to Cervical Cancer and Endometrial Cancer
- Acquisition of Partial Change to Approval for LYNOAMP™ CK19 in Japan -
Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces 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.
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.
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.
Product Overview
| Product name: | LYNOAMP™ CK19 (generic name: Cytokeratin 19mRNA kit) | ||
| Intended use: |
Detection of cytokeratin 19 (CK19) mRNA in the regional lymph nodes of breast, colorectal, stomach, non-small cell lung, cervical and endometrial cancers.
(Assist in the diagnosis of lymph node metastasis of breast, colorectal, stomach, non-small cell lung, cervical and endometrial cancer)
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| Registration number: | 23000EZX00019000 (Medical device registration number in Japan) |
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Reference
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Press release dated May 10, 2018: “Sysmex Launches New Products in Its System for the Testing of Cancer Lymph Node Metastasis Using the OSNA™ Method: Gene Amplification Detector RD-200 and LYNOAMP™ CK19”
https://www.sysmex.co.jp/en/news/2018/180510.html |
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Terminology
| 1 |
OSNA (One-Step Nucleic Acid Amplification) method:
A technique developed by Sysmex that does not require extraction or purification of nucleic acid in the pre-treatment process, enabling one-step amplification.
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| 2 |
Equalization of medical care:
Rectifying disparities in healthcare technologies so that standardized and specialized healthcare can be received at any location nationwide.
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Sysmex’s Materiality
| Sysmex has identified “Resolution of medical issues through products and services” as one of the issues that we prioritize (materiality), and is working to develop and supply products with high clinical value. Leveraging our proprietary technology and the global network that we have cultivated thus far, we continue to strive to contribute to the development of healthcare and the healthy lives of people. | |
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- The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising or medical advice. The information contained in this news release is current as of the date of the announcement but may be subject to change without prior notice.