Recently, the innovative product IFI44L Gene Methylation Detection Kit (PCR-Melting Curve Method) of ShenZhen Sciarray Biotechnology Co., Ltd. was approved by China NMPA.

　　This product adopts PCR melting curve method to qualitatively detect the DNA methylation level of the promoter region of IFI44L (interferon-induced protein 44-like) gene in human whole blood samples, and it can be used as an auxiliary diagnostic tool for systemic lupus erythematosus (SLE) combined with other indexes. This product, independently developed in China with intellectual property rights, is suitable to diagnose patients with SLE prior to the occurrence of vital organ involvement, which is of great significance to the prevention and treatment of SLE, improvement of patients' quality of life, and increase of patients' survival rate.

　　The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.