New Industries Bio obtains registration for PR3 antibody test

Shenzhen New Industries Biomedical Engineering Co., Ltd. (SZSE:300832) announced that it has received a medical device registration certificate from the Guangdong Provincial Drug Administration for its anti-proteinase 3 (PR3) antibody IgG assay kit, which utilizes magnetic particle chemiluminescence. The registration is valid from April 9, 2025, to April 8, 2030. This in-vitro diagnostic reagent is designed to quantitatively measure the level of anti-PR3 IgG antibodies in human serum and plasma, aiding in the diagnosis of ANCA-related vasculitis, including Wegener's granulomatosis (GPA). The company currently holds 192 chemiluminescence reagent registration certificates.