Sysmex Corporation (HQ: Kobe, Japan; President: Hisashi Ietsugu) announces its success in using LINOAMP BC, its OSNA*1 diagnostic reagent, to extend OSNA’s application from breast cancer to colon cancer. The Company received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare on December 17. Following its approval in 2008 for detection of breast cancer lymph node metastasis, the use of this diagnostic reagent in conjunction with a specific automated analyzer now enables the detection of colon cancer metastasis—the first instance in Japan of automated detection of lymph node metastasis.
The incidence of cancer is rising each year, and currently is responsible for more than 30% of all deaths in Japan. Certain types of cancer—colon cancer, along with lung cancer and stomach cancer—are particularly prevalent.
Under the present method of diagnosing colon cancer lymph node metastasis, following an operation a pathologist makes surgical incisions in 12 or more lymph nodes to prepare pathological samples. The pathologist then views these samples under a microscope to determine whether the cancer has metastasized. Post-operative treatment is based on the results of these tests, but conducting detailed diagnosis on large numbers of lymph nodes places a major burden on the pathologist.
Applying the OSNA method developed by Sysmex to rapid lymph node metastasis detection*2 simplifies testing, while conducting diagnosis at a level of precision equivalent to that achieved by the recommended method for the Japanese Classification of Colorectal Carcinoma (Japanese Society for Cancer of the Colon and Rectum)*3. Automating this testing allows diagnosis to be performed at the same level of precision, but in less time than was required for conventional systems.This contributes to objective and appropriate decisions on post-operative treatment, reduces the burden on pathologists and contributes to the standardization*4 of post-operative treatment of colon cancer.
This testing for lymph node metastasis of colon cancer can be conducted using the same instrument and reagent that Sysmex began offering in 2008 as a breast cancer lymph node metastasis testing system.
Sysmex will continue working to expand the market for rapid lymph node metastasis detection systems, thereby helping to promote the standardization of lymph node metastasis detection. In addition, the Company will continue its research and development of lymph node metastasis testing using the OSNA method on other types of cancer, including stomach cancer.
*1 Abbreviation for One-Step Nucleic Acid Amplification, a method developed by Sysmex. Enables metastasis at a single lymph node to be determined in approximately 30 minutes.
*2 Sysmex has received manufacturing and marketing approval for a detection system comprising the LINOAMP BC gene amplification reagent and the RD-100i gene amplification detector, a specific automated analyzer.
*3 Method for analyzing excised lymph nodes at 2mm intervals to determine metastasis.
*4 Correction for disparities, such as healthcare technology that enables patients to receive the same level of specialized treatment nationwide, regardless of location.