The First CAR-T Companion Test Product Entered The National Special Review of Innovative Medical Devices

Recently, the Center for Medical Device Evaluation (CMDE) of the State Drug Administration announced the results of the special review application for innovative medical devices (No. 2 of 2022), showing that Shanghai Xingwan Biotechnology Co., Ltd. The anti-CD19-chimeric antigen receptor T cell detection kit (flow cytometry-PE) independently developed and produced by Xingwan Bio has passed the special review application for innovative medical devices.

This is also 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 publicity.

Star Bay Bio was established in July 2018, focusing on the accurate detection of cell therapy, providing CAR-T pharmaceutical companies and clinical institutions with detection products such as pharmacokinetics, ADA/Nab, single-cell sequencing, mass cytometry, as well as research and development, quality control, Total solution for clinical testing.

For CAR-T cell therapy, the detection of CAR-T cells in patients is very important. CAR-T therapy mainly uses genetic engineering technology to transform T lymphocytes of tumor patients in vitro, generate tumor-specific CAR-T cells after mass culture in vitro, and then inject them back into patients to attack cancer cells, thereby achieving the treatment of diseases. The goal. 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 Toxic and Side Effects of CAR T Cell Treatment of NHL was published by the expert organization of the Special Committee of Biotherapeutics of the Chinese Research Hospital Association, pointing out that acute CRS, chronic CRS, abnormal proliferation of CAR-T cells, hemophagocytic The diagnosis of clinical acute toxic and side effects such as lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) requires the detection of CAR-T proliferation in patients.

Therefore, after the CAR-T cells are reinfused, the detection of CAR-T in the patient is essential, and the sensitivity of the anti-CD19 CAR-T flow detection product independently developed and declared by Xingwan Bio can reach 1/100,000. Compared with Novartis' clinical testing level (1/1000), it has been significantly improved. At present, 2 CAR-T products have been approved in China, and many CAR-T products are under development. It may help the clinical accurate detection of these drugs.