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Effective November 1, 2008, coverage under the Japanese national health insurance program was extended to detection of breast cancer lymph node metastasis by the One-Step Nucleic acid Amplification (OSNA) method developed by Sysmex Corporation (HQ: Kobe, Japan; President: Hisashi Ietsugu).
The detection system, which consists of a dedicated reagent (Gene Amplification Reagent LINOAMP BC) and analyzer (Gene Amplification Detector RD-100i) licensed by the Ministry of Health, Labour and Wefare on June 6, 2008 for manufacture and sale, represents the first Japanese technology of this type to automate metastasis determination and to be covered under national health insurance.
In cases of surgery for breast cancer, a histopathological analysis is conventionally done twice (during and after the operation) in order to determine whether or not the cancer has spread to the lymph node. The results provide footing for decisions on the scope of resection and type of post-operative treatment. At present, however, there are various issues, including the difficulty of determining metastasis within the limited time during surgery. The situation is compounded by a shortage of skilled pathologists, and is regarded as one of the major problems facing treatment of breast cancer.
The aforementioned system (RD-100i plus LINOAMP BC) for rapid detection of breast cancer metastasis in the lymph node applying the OSNA method determines the presence or absence of metastasis by detection of the cytokeratin 19 mRNA in the lymph node. It enables a decision on metastasis with a very high degree of accuracy in the space of about 30 minutes.
The ability to tell whether or not cancer has metastasized to the lymph node in the course of surgery makes it possible to dissect axillary lymph nodes that might have metastasis during the same operation. As such, it alleviates the burden on the patient due to resurgery and lowers the risk of local recurrence. In addition, it enables sure selection of the proper method of treatment for possible distant metastasis. Furthermore, automation and simplification of the examination make it possible to obtain objective results that are not dependent on the skill level of the operator. As such, the system will help to lighten the burden on pathologists and equalize treatment for breast cancer.
As for future action, in addition to promoting steady marketing of the system, we are going to take steps aimed at enabling application of this technology for metastasis examinations for gastric, colorectal, and other types of cancer.
Outline of insurance coverage
Item of measurement: cytokeratin (CK) 19 mRNA
Measurement method: OSNA method
Main purpose of measurement: detection of cytokeratin (CK) 19 mRNA in the regional lymph node of breast cancer (use to assist diagnosis of breast cancer metastasis in lymph node)
Point value: 2000
Diagnosis fee: hematological examination diagnosis fee - 125 points (limited to once a month)
Product profile
Outline of lymph node metastasis examination
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