Highly Accurate Serological Biomarker for Early Detection of Nasopharyngeal Carcinoma

University of Pittsburgh researchers have developed a serological biomarker test for the risk prediction of Epstein-Barr virus (EBV)-associated nasopharyngeal carcinoma (NPC). This test utilizes a multiplex immunoblot method to measure IgA antibodies against the EBV nuclear antigen 1 (EBNA1) in human serum, achieving 100% sensitivity and 100% specificity up to three years before NPC diagnosis. This breakthrough offers a highly accurate tool for early detection and risk prediction of NPC, particularly in endemic regions.

Description

The innovative test involves cloning an EBV open-reading frame (ORF) mammalian expression library produced in human cells to survey EBV antibody reactivity. Using a multiplex immunoblot method, the test measures IgG, IgA, and IgM EBV antibodies normalized to the EBV protein expression level by detecting the introduced FLAG-epitope. This method overcomes the limitations of ELISA-based tests, which often suffer from false positives, and provides a high-throughput solution for NPC risk prediction.

Applications

• Early detection of nasopharyngeal carcinoma
• Risk prediction for EBV-associated cancers
• Screening tool for NPC in endemic populations
• Enhancing cancer prevention strategies

Advantages

This serological biomarker test offers unparalleled accuracy with 100% sensitivity and specificity, significantly reducing false positives and improving early detection of NPC. The multiplex immunoblot method provides a high-throughput and reliable solution for screening, making it a valuable tool for healthcare providers in endemic regions. By identifying individuals at risk up to three years before clinical diagnosis, this test can lead to timely interventions and better patient outcomes.

Invention Readiness

The technology is currently at the in vitro data stage. Initial studies have demonstrated the test's effectiveness in predicting NPC risk with high accuracy. Further validation and development are ongoing to refine the test and prepare it for clinical use.

IP Status

https://patents.google.com/patent/WO2023212703A1