Human Papillomavirus E7 and p16 INK4a mRNA Multiplexed Quantification by a QuantiGene TM Proof-of-Concept Assay Sensitively Detects Infection and Cervical Dysplasia Severity.

The QG-POC assay is sufficiently sensitive to detect and quantify HPV-E7 and cellular mRNA species. Multiplexing allows the specific detection of at least 10 analytes in a single reaction. Determining the abundance of E7 and p16 transcripts when normalized to ACTB is informative about the presence of cervical dysplasia and potentially discriminates between low-grade and high-grade dysplasia and invasive cervical cancer. Further studies including more HPV genotypes and biomarkers are warranted.