Insurance Coverage for Rapid Detection of Colorectal Cancer and Stomach Cancer Lymph Node Metastasis Based on the OSNA® Method
Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces that rapid detection of colorectal and stomach cancer lymph node metastasis based on the OSNA method*, which Sysmex developed, is covered by insurance effective October 1, 2013.
Sysmex has succeeded in using the OSNA method, a technology that Sysmex developed, to automate the rapid detection of molecular biological lymph node metastasis for breast, colorectal cancer and stomach cancer. Sysmex has obtained approval from Japan's Ministry of Health, Labour and Welfare for the manufacture and marketing of instruments and dedicated reagents for employing this method. In November 2008, the Sysmex system for rapid detection of breast cancer lymph node metastasis was covered under national health insurance.
As of October 1, 2013, in addition to breast cancer Sysmex systems employing the OSNA method for the rapid detection of colorectal cancer and stomach cancer lymph node metastasis are also being covered by this insurance.
The existence of lymph node metastasis is typically determined 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 the cancer has metastasized. However, this testing places a major burden on pathologists, and the medical arena is plagued by a shortage of pathologists.
Employing the OSNA method for the rapid detection of molecular biological lymph node metastasis involves using the RD-100i gene amplification detector and LINOAMP BC gene amplification reagent, allowing the existence of metastasis to be determined in as little as 30 minutes. As a result, testing is automated and more efficient and accurate. The accurate determination of colorectal cancer enables the selection of optimal treatment methods. For stomach cancer, this approach contributes to the diagnosis of metastasis, including selection of the lymph node dissection region and stomach excision region, and assists in the determination of treatment methods. Consequently, the method helps to reduce the burden on patients.
Going forward, Sysmex will work toward the further expansion of the market for the rapid detection of lymph node metastasis using the OSNA method, as well as the standardization of medical services and the development of personalized medicine.
|Outline of Insurance Coverage|
|Item of measurement:||Cytokeratin 19 (KRT19) mRNA|
|Measurement method:||OSNA method|
|Main purpose of measurement:||Detection of cytokeratin 19 (KRT19) mRNA in the regional lymph node of colorectal or stomach cancer (assist in the diagnosis of lymph node metastasis of colorectal or stomach cancer and determination of operating procedure and other treatment methods)|
|Point value:||2,400 (limited to once per course of treatment)|
|Diagnosis fee:||Hematological examination diagnosis fee: 125 points (limited to once a month)
* OSNA method: Abbreviation for One-Step Nucleic acid Amplification, a method developed by Sysmex. This method enables metastasis of a lymph node to be determined in approximately 30 minutes.