In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents XVI

3.2 Tumor Diagnostic Reagents

Lymphoma, also known as malignant lymphoma, is a general term for a group of malignant tumors originating from the lymphopoietic system. It is one of the most common tumors in China. In 2020, there were 544,352 new cases of non-Hodgkin lymphoma (NHL) worldwide, ranking 13th among all new cases of malignancies. The immunoglobulin gene rearrangement test is one of the methods for the pathological diagnosis of lymphoma, but there has been a long-standing lack of approved products. Immunoglobulin Gene Rearrangement Detection Kit (Capillary Electrophoresis method) (Registration No.: G.X.Z.Z. 20,203,400,736) of Suzhou Yuntai Bio-Tech Ltd. is the first in vitro immunoglobulin gene rearrangement detection molecular diagnostic product approved in China, which can qualitatively in vitro detect clonal immunoglobulin gene rearrangement status in human formalin-fixed paraffin-embedded sections (FFPE) samples. It is used for the auxiliary diagnosis of B-cell non-Hodgkin lymphoma.

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