Sysmex Corporation (HQ: Kobe, Japan; President and CEO: Hisashi Ietsugu) announces its receipt of approval of an application from Japan's Ministry of Health, Labour and Welfare for extending the application of LYNOAMP BC, a diagnostic reagent used in its system for rapid detection of lymph node metastasis - a mainstay product in the Company's life science business - to stomach cancer, in addition to breast cancer and colon cancer on July 12, 2012.
Each year, throughout the world approximately 1 million people are said to be affected by stomach cancer. Japan accounts for approximately 110,000 of these patients, and the rate of death from this type of cancer is second only to lung cancer, for men and women alike. During treatment for stomach cancer, the existence of lymph node metastasis is one determinant of the cancer's progression. In addition to whether this metastasis occurs, knowing the number of metastases and their locations can help a physician decide on treatment methods, such as whether to excise a portion of the stomach or to use anti-cancer agents.
Sysmex introduced a system for the automated and rapid detection of breast cancer lymph node metastasis in 2008, and began offering related reagents and instruments, extending this application to colon cancer in 2010. Praised highly for its ability to determine the existence of breast cancer lymph node metastasis in only around 30 minutes, Sysmex's system has been adopted globally especially in regions such as Japan and Europe. Also playing a role in the standardization of rapid detection of lymph node metastasis is the 2011 edition of the Breast Cancer Examination Guidelines2, which is provided as a reference to physicians for diagnosing breast cancer.
The approval of extended application it has received allows Sysmex to provide the same reagents and instruments as are used for determining lymph node metastasis of breast cancer and colon cancer to determine the existence of lymph node metastasis of stomach cancer.
By developing the OSNA method3 used in its lymph-node metastasis rapid detection system4, Sysmex enables the rapid detection of metastasis over all lymph nodes. This system allows more rapid detection, making the rapid detection of stomach cancer lymph node metastasis more precise, and is expected to contribute to better decisions regarding treatment methods.
Going forward, Sysmex looks forward to further global development of its system for detecting lymph node metastasis using the OSNA method, as well as to its contribution to the standardization of rapid detection of lymph node metastasis in other types of cancer.
||Guidelines produced by the Japanese Breast Cancer Society as a reference for physicians regarding breast cancer examinations. The guidelines cover five areas - drug therapy, surgical procedures, radiation therapy, examination and diagnosis, and epidemiology and prevention - and are updated once every three years.
||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.
||A diagnostic system comprising the RD-100i gene amplification detector, a specific automated analyzer, and the LYNOAMP BC gene-amplification reagent, for which approval of extended application has been received.
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but may be subject to change without prior notice.