Human papillomavirus detection
A multiplex qPCR assay for HPV16 and HPV18 nucleic acids provides rapid, sensitive, and specific detection in clinical pathology labs, overcoming the limitations of current OPSCC diagnostics by using optimized oligonucleotide sets for improved genomic coverage and cost-effective implementation.
Patent Information
- Application Number
- PCT/US2025/047892
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-09-30
- Filing Date
- 2025-09-25
- Publication Date
- 2026-04-02
AI Technical Summary
Current diagnostics for oropharyngeal squamous cell carcinoma (OPSCC) associated with high-risk HPV lack sensitivity, specificity, and cost-effectiveness, and are impractical for clinical implementation, leading to inadequate management and screening, and existing HPV biomarkers are not optimized for rapid, flexible use in clinical pathology laboratories.
Development of a multiplex single-tube qPCR assay for detecting HPV16 and HPV18 nucleic acids using oligonucleotide sets with high sequence identity, allowing for rapid, sensitive, and specific detection in a single step, suitable for clinical pathology laboratories, without requiring digital PCR instruments.
The assay achieves high analytical sensitivity and specificity, with a rapid turnaround time, suitable for clinical pathology laboratories, and improved genomic coverage, addressing the limitations of existing diagnostics.