Recently, the application for registration of 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 (IFN)-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, developed independently by China and boasting its own intellectual property rights, possesses the capability to diagnose patients with systemic lupus erythematosus prior to the occurrence of vital organ involvement, which is of great significance to the prevention and treatment of systemic lupus erythematosus, improvement of patients' quality of life, and enhancement 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.