Advanced Cell Diagnostics, Inc. (ACD) today announced the results of its clinical study utilizing RNAscope™ technology to detect human papillomavirus (HPV) E6/E7 mRNA in routine clinical specimens of head and neck cancer. HPV status determined by the RNAscope™ HPV test was highly predictive of patient outcome and highly concordant with that determined by existing methods. Significantly, the RNAscope™ test under development demonstrated 16% higher detection sensitivity than the HPV DNA test used in the study.
These results will be presented today at the 100th annual meeting of United States & Canadian Academy of Pathology (USCAP 2011). The RNAscope™ HPV test detects E6/E7 mRNA from seven high risk HPV genotypes known to be associated with certain head and neck cancers. The study included 211 head and neck cancers from the oropharynx (base of tongue and throat). It compared the RNAscope™ test with two other tests detecting HPV DNA and the cellular protein p16. RNAscope™ identified 78% of the cases to be positive for HPV, compared to 62% and 79% by the HPV DNA and p16 assays, respectively. HPV-positive tumors as determined by RNAscope™ were associated with 77% lower risk of death following standard therapies (hazard ratio = 0.23, p < 0.001 for overall survival and disease-specific survival), compared to HPV-negative tumors.
"To determine whether a tumor is caused by HPV, it requires more than just detecting the presence or absence of the virus. Detecting transcriptionally active HPV in the tumor cells is critical to establish its presence as clinically significant," said Dr. James Lewis Jr. of Washington University in St. Louis, the principal investigator in this collaborative study. "The RNAscope™ assay uniquely addresses this clinical need by detecting the viral E6/E7 mRNAs and allowing their direct visualization in the tumor cells," continued Dr. Lewis.
"The incidences of HPV-associated head and neck cancers are increasing rapidly in the US and worldwide, and the clinical community has been looking for a robust, definitive HPV test," said Dr. Xiao-Jun Ma, Chief Scientific Officer of ACD, "E6/E7 mRNA has long been recognized as the best biomarker for HPV-associated cancers, but its detection by RT-PCR has been limited to research use only due to the complexity of dealing with formalin-fixed paraffin-embedded (FFPE) tissue specimens. This study demonstrated that RNAscope™ is well suited for bringing E6/E7 mRNA testing into the clinic."
"ACD aims to empower pathologists in molecular diagnostics by making RNAscope™ seamlessly compatible with routine FFPE tissue specimen and with existing workflow in pathology labs," commented Dr. Yuling Luo, President & CEO of ACD. Dr. Luo continued, "The outcome of this study is the first concrete evidence that we have made significant progress toward this goal."