On March 1, 2022, the National Device Review Center issued an announcement announcing that the anti-CD19-chimeric antigen receptor T cell detection kit (flow cytometry-PE) was independently developed and produced by Bioswan. The application for special review of innovative medical devices has been passed. This is the first CAR-T cell therapy clinical testing product in China to enter the innovative "green channel" so far. It only takes 35 working days from application acceptance to public announcement.

　　CAR-T cell therapy, mainly through genetic engineering technology, transforms T lymphocytes of tumor patients in vitro, generates tumor-specific CAR-T cells after mass culture in vitro, and then reinfuses them into the patient's body to attack cancer cells, and then achieve the goal of treating the disease. However, CAR-T therapy does not stop at cell infusion. CAR-T is a "living" drug, and its efficacy, acute and chronic side effects, risk of recurrence, etc., are closely related to the changes of CAR-T in the body. In 2021, the Expert Consensus on Clinical Management of CAR-T Cell Therapy for NHL Toxicity and Side Effects published by the expert organization of the Biotherapeutics Committee of China Research Hospital Association pointed out: the diagnosis of acute CRS, chronic CRS, abnormal proliferation of CAR-T cells, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) and other clinical acute toxic and side effects all require the detection of CAR-T proliferation in patients . It can be seen that after CAR-T cells are reinfused, the detection of CAR-T in patients is essential.

　　With the launch of two autologous CAR-T cell therapy products targeting human CD19, Fosun Kite's Yikaida and WuXi Junuo's Benoda, the need for accurate clinical detection has become more and more urgent. In order to solve this problem, Bioswan independently developed and applied for the first anti-CD19 CAR-T flow detection product in China. This is the product with the highest detection sensitivity to date.

　　About Bioswan

　　Bioswan was established in July 2018 and is a national high-tech enterprise. Bioswan focuses on accurate detection of cell therapy, providing CAR-T pharmaceutical companies and clinical institutions with sensitive and accurate detection products such as pharmacokinetics, ADA/Nab, single-cell sequencing, and mass cytometry, as well as providing overall solutions for R&D, quality control, and clinical testing , thereby contributing to better cell therapy.