Press Release

Promoting Initiatives to Enhance Clinical Value of the OSNA® Method

- Further Raising Value by Improving Workflow in the Detection of Breast Cancer Lymph Node Metastasis -

   In 2008, Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) employed its proprietary technology, the One-Step Nucleic Acid Amplification (OSNA) method, in a system that-for the first time in Japan-enabled the automated rapid detection of breast cancer lymph node metastasis. Since that time, the Company has moved forward with initiatives to boost clinical value and introduce products on a global basis.
  Sysmex has commenced sales in the Japanese market of the Pretreatment System RP-10 as part of its aim to achieve further standardization and accelerate the detection of lymph node metastasis in different types of cancer.

  In cases of surgery for early-stage breast cancer, a histopathological analysis is conventionally performed twice (during and after the operation), in order to determine whether or not the cancer cells have spread to the lymph node. The results provide a basis for decisions on the scope of resection and post-operative treatment. However, various issues exist with regard to the detection of lymph node metastasis, including conducting tests during the limited duration of surgery, difficulty in determining small metastasis and a shortage of skilled pathologists.

  Against this backdrop, Sysmex developed the OSNA method to standardize and accelerate the detection of lymph node metastasis, thereby reducing the burden on pathologists and breast cancer patients alike.
  Using the OSNA method automates and simplifies examinations, making it possible to obtain objective results. As such, the system helps to lighten the burden on pathologists and equalize treatment for breast cancer. As the system can be used during surgery to determine the existence of lymph node metastasis, it helps to reduce the burden on the patient caused by a second surgery.

  Overseas entities rate the OSNA method highly for its precision and performance. For example, the Spanish Society of Senology and Mammary Pathology (SESPM) recommends use of the OSNA method in the detection of breast cancer lymph node metastasis in its diagnosis guidelines, and the U.K. National Institute for Health and Clinical Excellence (NICE) also recommends the method too. In Japan, the method received a recommendation grade of "A" in the Japanese Breast Cancer Society's breast cancer diagnosis guidelines as an alternative to pathological testing of sentinel lymph nodes.

  Application also continues to expand to other types of cancer. In 2013, insurance coverage commenced for the rapid detection of colorectal and stomach cancers based on the OSNA method. The OSNA method is published in some 60 scientific articles, further attesting to its clinical value.

  In its aim to further standardize and accelerate the detection of lymph node metastasis using the OSNA method, Sysmex has commenced sales in the Japanese market of the RP-10 pretreatment instrument, which conducts automatic lymph node fragmentation and solubilization.
  Testing that employs the OSNA method requires fragmentation and solubilization of the lymph node specimen, and presently homogenizing instruments* are used to conduct pretreatment manually.
  Using the RP-10 for pretreatment instead of a manual method can reduce measurement time by nearly 10%. This increases efficiency during surgery, improves the workflow of the person conducting the testing and reduces the burden on the patient.

  Going forward, Sysmex will strive to expand the market for testing systems that employ the OSNA method and work on initiatives to standardize the detection of lymph node metastasis in various cancer types.

New Product Overview
1. Product name: 
Pretreatment System RP-10
2. Features    
    (1) Configuration: Lymph node fragmentation/solubilization
    (2) Processing capacity:  Up to 4 lymph nodes/batch
    (3) Processing time: Approx. 1.5 minutes/batch
    (4) Size: 391 mm (W) x 267 mm (D) x 500 mm (H) 
    (5) Weight: Approx. 23 kg 
Pretreatment System PR-10
Pretreatment System PR-10

Homogenizing instrument: A homogenizer is an instrument that mechanically reduces particles (in solids) and droplets (in liquids) to extremely small sizes. Reducing the size of solid and liquid particles makes separation less likely and results in a more uniform state.

  • Information contained in the press release is current as of the date of the announcement,
    but may be subject to change without prior notice.

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