NEW YORK — Japanese diagnostics firm Sysmex said on Wednesday that it has received Class III approval from China’s National Medical Products Administration for its Lynoamp BC in vitro diagnostic reagent.
According to Sysmex, the reagent is used for the detection of cytokeratin 19 mRNA in sentinel lymph nodes removed during breast cancer surgery in order to diagnose lymph node metastasis. It is designed to run on the company's RD-100 gene amplification detector system using a proprietary one-step nucleic acid amplification method. Results whether lymph node metastasis has occurred can be achieved within about 30 minutes using Sysmex's technology, the company said.
Sysmex said that it is currently creating a framework for introducing Lynoamp BC-based breast cancer lymph node metastasis testing into the Chinese market.