Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces the launch of the Gene Amplification Detector RD-200 and the LYNOAMP™CK19 gene-amplification reagent, new products in its system for the rapid detection of cancer lymph node metastasis using the OSNA™ method1 developed by the Company. We will launch these products in Japan and plan a gradual rollout to other markets. By providing a new system with an enhanced sample processing capacity, we aim to promote the further popularization of the detection of cancer lymph node metastasis using the OSNA™ method, as well as contributing to the standardization of healthcare.
During cancer treatment, testing assists in accurately diagnosing whether lymph node metastasis has occurred, and is important in the determination of operating procedures and other treatment methods. This testing 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 type of testing presents a number of issues in medical settings: sample preparation places a burden on workers; sample quality depends on the skill of the person preparing the samples; and determining accuracy may differ by pathologist.
In 2006, Sysmex launched the Gene Amplification Detector RD-100i and the LYNOAMP™BC gene-amplification reagent for clinical use as a system for the testing of cancer lymph node metastasis using the OSNA™ method. This system allows for the testing to be performed within approximately 30 minutes, assisting in the diagnosis of lymph node metastasis. Automating and simplifying the testing enables the provision of objective test results that are independent of operator skill. In addition, this system lightens the burden on pathologists, promotes the equalization of diagnosis2, and contributes to the determination of treatment methods that take into account the burden on patients and their quality of life. Furthermore, our system for using the OSNA™ method to test for breast cancer, colorectal cancer, stomach cancer and non-small-cell lung cancer is the only test for lymph node metastasis using a genetics-based approach to receive insurance coverage in Japan. The system has been installed at more than 100 healthcare institutions, and is used by more than 200 institutions overseas.
In treating breast cancer, intraoperative diagnosis of the presence of lymph node metastasis helps determine the resection area. For this reason, shortening testing times further is desirable from the perspective of lightening the intraoperative burden on the patient. Also, when treating colorectal and stomach cancer, determining the metastasis of multiple lymph nodes resected from a patient is needed when choosing post-operative treatment methods. This situation calls for increasing the number of samples that can be measured simultaneously.
The Gene Amplification Detector RD-200 and LYNOAMP™ CK19 gene-amplification reagent maintain the same or higher levels of testing precision as histopathological examinations. In addition, compared with current systems for the detection of cancer lymph node metastasis, the new system increases the maximum number of samples that can be measured simultaneously (from 4 to 14 samples) and shortens measurement time by approximately 34% (when measuring four samples). By providing a new system that increases sample processing capacity in line with market needs, Sysmex aims to promote the globalization of testing for lymph node metastasis of breast, colorectal and stomach cancer, as well as contributing to test quality enhancement and standardization.
Going forward, Sysmex will continue working toward the further global rollout of its system for the detection of cancer lymph node metastasis using the OSNA™ method. In this way, we will encourage the development of personalized medicine, contributing to the standardization of healthcare and improvements in patient quality of life.
1 OSNA™ method: Abbreviation of One-Step Nucleic Acid Amplification method, developed by Sysmex, which enables detection of lymph node metastasis.
2 Equalization of diagnosis: Rectifying disparities in healthcare technologies so that standardized and specialized healthcare can be received at any location nationwide.