SAN ANTONIO, Feb. 28, 2011 /PRNewswire/ — 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
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