Automation of examinations to detect breast cancer lymph node metastasis: a first in Japan

- Acquisition of approval from the MHLW for the manufacture and sale of our in-vitro diagnostic agent used for detection of breast cancer lymph node metastasis -
Information contained in the press release is current as of the date of the announcement,but may be subject to change without prior notice.

On June 6, 2008, Sysmex Corporation (HQ: Kobe Japan; President: Hisashi Ietsugu) acquired approval from the Ministry of Health, Labour and Welfare (MHLW) to manufacture and sell a reagent used for detecting breast cancer metastasis to the lymph nodes as an in-vitro diagnostic agent. During surgery for early-stage breast cancer, it has been normal procedure to determine whether or not cancer has metastasized to the lymph node by performing a histopathological diagnosis based on microscopic observation. By integrating use of the reagent with our dedicated analyzer this procedure can now be performed automatically in Japan for the first time.



The onset of the aging society is accompanied by increasing cases of cancer and lifestyle-related diseases. At the same time, there is mounting interest in maintaining quality of life (QOL) and good health over the entire span of a human life. In addition, in the U.S. and Europe as well as in Japan, authorities are deploying medical policies that represent a shift of emphasis from therapy to prevention, in order to extend healthy lifespan and curtail medical costs.

Realizing that examinations will assume even more importance for early detection of disease and prevention of recurrence, we at Sysmex have focused on the life science field from early on. We are applying our technical expertise gained in life science to the creation of examination technology that can contribute to improving patient QOL. Such improvement in QOL is needed by patients throughout the world, so we believe that the new technology will generate new markets and help to equalize medical services.* Paying particular attention to the area of cancer, we are developing new examination techniques that utilize technology used for analyzing the action of genes and proteins and enables disease management for cancer.

Where surgery is used for early-stage breast cancer, it has been normal procedure to make a histopathological diagnosis twice (during and after the operation) in order to determine whether or not the cancer has spread to the lymph nodes. The findings of these two examinations provide a basis for decisions regarding subsequent treatment options such as the extent of excision required and post-operative adjuvant therapy. This procedure is associated with several drawbacks, however, such as the need to perform the procedure within a limited time during the operation and the difficulty of determining the presence or absence of metastasis. The situation is compounded by the shortage of skilled pathologists, and has become one of the problems confronting the treatment of breast cancer.

Based on the one-step nucleic acid amplification (OSNA) method that Sysmex developed, our system for rapid detection of breast cancer lymph node metastasis (comprising the gene amplification detector RD-100i used in conjunction with the gene amplification reagent LYNOAMP BC) delivers results with the same level of precision as the conventional procedure in about 30 minutes. Intra-operative detection of metastasis to the lymph nodes in surgery for early-stage breast cancer enables excision of the affected lymph node during the same operation, and therefore helps to lighten the burden on patients by lessening the need for resurgery while lowering the risk of recurrence. Furthermore, the automation and simplification of the biopsy make it possible to obtain objective results that are not dependent on the skill level of the operator. As such, the system will reduce the workload imposed on pathologists and help to standardize the diagnosis and treatment of breast cancer.

For the future, we are going to work for the prompt market introduction and diffusion of the system and also strive to extend the application of this technology to the detection of metastasis in gastric, colon, and other types of cancer.

* Rectification of regional disparities in respect of medical technology, to enable all patients throughout Japan to receive standardized and specialized medical care.