Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, announced last week that it has received marketing approval from the National Medical Products Administration for its EB virus BNLF2b antibody (P85 Ab) detection kit, which utilizes the magnetic particle chemiluminescence method. This product is a collaborative achievement between Wantai Bio and Xiamen University in China.
Previously, a research team led by Xia Ningshao from Xiamen University made a groundbreaking discovery of a new serological marker for nasopharyngeal carcinoma—the total antibody against the hypothesized protein encoded by the BNLF2b gene (P85 Ab). This novel biomarker, P85 Ab, offers higher sensitivity, specificity, and positive predictive value for nasopharyngeal carcinoma screening and complements existing diagnostic protocols, enhancing the effectiveness of screening processes.
A prospective cohort study for nasopharyngeal carcinoma screening, conducted by a team from Xiamen University and including 24,852 subjects, evaluated the performance of the P85 Ab kit. The study demonstrated that the sensitivity of the P85 Ab kit was 97.9% and the specificity was 98.3%. Compared to existing screening methods, the detection rate of early nasopharyngeal carcinoma increased by 26.3% (97.4% vs. 71.1%), and the positive predictive value more than doubled (10.0% vs. 4.3%). With the addition of dual-antibody testing following positive P85 Ab screening, the specificity rose to 99.8%, and the positive predictive value increased to 44.6%. This indicates that approximately every 2 individuals requiring nasopharyngeal endoscopy can be diagnosed with nasopharyngeal carcinoma, significantly reducing the number of necessary examinations. These results were published in the New England Journal of Medicine in 2023. The follow-up screening for this study is ongoing, and as of the end of 2023, the screening population has expanded to 51,000 people, with results highly consistent with the published findings.- Flcube.com
