EEMAPS study shows mtm’s p16/Ki-67 dual immuno-staining superior to Pap and HPV testing for identifying cervical disease
mtm laboratories announced the presentation of a study showing that dual staining for p16 and Ki-67 can pinpoint the underlying high-grade cervical disease with a high degree of sensitivity and specificity in women with ASC-US or LSIL cytology results. This study used the advanced biomarker combination CINtec® PLUS that was launched by mtm on March 8 2010 in Europe and the full results will be presented today at the 17th International Congress of Cytology, Edinburgh.
ASC-US and LSIL define equivocal and mild to moderate abnormal cytology findings on Pap tests, and may represent 5-8% of all cervical cytology cases. While most of these findings are negative for high-grade disease, 15-20% of LSIL and 6-10% of ASC-US will harbour high-grade disease. Together, these two categories of cytology represent the source for about 60% of all cases of high-grade cervical disease in women. Unfortunately, due to the low rates of underlying disease these Pap cytology results are not adequate predictors to determine which ASC-US or LSIL cases require intervention. In addition, adjunctive HPV testing has limitations due to poor specificity.
In the EEMAPS study, residual materials from a previous pan-European retrospective cytology study were used to prepare additional slides for p16 and Ki-67 dual immuno-staining. A total of 362 ASC-US and 415 LSIL cases with corresponding biopsy results and HPV test results were available for analysis. The presence of one or more dual-stained cervical epithelial cell(s) defined a positive test result with CINtec® PLUS , independent from morphology interpretation. The clinical results showed that the sensitivity of the dual stain for high-grade disease was 92.2% (71/77) for ASC-US, and 94.2% (129/137) for LSIL cases, which is equivalent to the sensitivity results obtained for HPV testing. However, specificity was significantly higher for CINtec® PLUS as compared to HPV testing; 80.6% vs. 36.3% for ASC-US and 68.0% vs. 19.1% for LSIL. CINtec® PLUS is the first test that provides high sensitivity and high specificity for underlying high-grade cervical disease in a single product, irrespective of women’s age and HR-HPV type of infection.
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