Sysmex Receives Regulatory Approval in China of an in Vitro Diagnostic Reagent to Help Diagnose Breast Cancer Lymph Node Metastasis Using the OSNATM Method -Aiming to Introduce a System to Test for Breast Cancer Lymph Node Metastasis into the Chinese
(WorldNews Health)

Jan. 22, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) received regulatory approval on December 9, 2019 from China`s National Medical Products Administration (NMPA) for LYNOAMPTM BC, an in vitro diagnostic reagent. Our system to test for breast cancer lymph node metastasis using the OSNATM method has received Class III1 regulatory approval as the first product for lymph node metastasis testing using a molecular biological technique. The Japanese Breast Cancer Society`s Breast Cancer Clinical Practice Guideline has described a lymph node metastasis testing system for breast cancer using the OSNATM method as an alternative to the H&E staining test2 for the...