Campbell, CA, February 19, 2010 - Hunter Laboratories Presents Clinical Study on New HPV RNA Test that Improves Specificity and Can Be Used Effectively in Women Less Than 30 years Old

On Saturday at Eurogin 2010 in Monte Carlo, Monaco, Dede Pierry from Hunter Laboratories presented data on over 3000 women describing the improved performance of Hunter’s HPV E6, E7 mRNA test over currently available HPV tests. In particular, Hunter’s test demonstrated increased specificity for pre-cervical cancer and cervical cancer in women with abnormal Pap smears compared to currently available HPV DNA tests. In addition, the authors concluded that the Hunter HPV test is effective for cervical cancer screening in women under 30 because it detects the presence of pre-cervical cancer lesions rather than the presence or absence of of HPV. The Eurogin conference held in Monaco is one of the premier HPV conferences in the world attracting over 1000 attendees and thought leaders. Hunter Labs was selected for the following presentation:

INTRACELLULAR HPV E6, E7 mRNA QUANTIFICATION (HPV ONCOTECT) PREDICTS CIN 2/3 IN BIOPSIES BETTER THAN PAP SCREENING FOR WOMEN REGARDLESS OF AGE

Lack, B; Pierry, D; Chen, V; Fusco, J; and Weiss MD, G.

Objective: Current recommendations for cervical cancer screening involve the use of the Pap smear and HPV testing. The combination of these tests is necessary since cervical cytology (Pap) has relatively low sensitivity but high specificity and conversely HPV DNA testing has high sensitivity but low specificity for dysplasia and cancer. We wanted to investigate avenues for improvement over the current screening algorithm.

Methods: We analyzed 3133 liquid based cytology specimens from women aged 19 to 75 using HPV Oncotect E6, E7 mRNA detection kit and compared the results to cytology and in 200 cases referred to biopsy. In addition, p16 immunohistochemistry was performed on a subset of equivocal biopsy specimens.

Conclusion: We report the use of an intracellular HPV E6, E7 mRNA quantification platform (HPV OncoTect), a single test, shows greater sensitivity and specificity than pap for CIN 2/3 on biopsy. HPV Oncotect was positive in 69% of CIN 2 and 89%of CIN 3 cases in all women analyzed. The specificity of HPV OncoTect was 94.5%. In women <30 years old HPV Oncotect detected 90 % of CIN 2/3 indicating this could be a valuable diagnostic for the under 30 age group. The mRNA detection method outperformed cytology in 60% of HSIL cases and showed 50% correlation with p16 staining performed on biopsies. HPV Oncotect demonstrates similar sensitivity to HPV DNA and greater sensitivity than pap for the detection of CIN 2/3 in cervical biopsies. HPV Oncotect shows much greater specificity than both HPV DNA and pap for CIN 2/3. In cases where longitudinal biopsy data was available, the quantitative E6, E7 mRNA result was also able to predict CIN progression/regression. HPV Oncotect demonstrates a performance profile that might allow for use in primary cervical cancer screening.