Julia Engstrom Melnyk - The new role for HPV DNA testing cobas HPV Test as a first line cervical...

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For the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology -- if it is negative, women are rescreen in three years and if positive, are referred to follow-up examinations. Although this strategy has led to a tremendous reduction in the incidence of cervical cancer, some significant limitations exist. Cytology has low sensitivity for cervical cancer pre-cursors, has low reproducibility, and does not adequately assess long-term risk. HPV testing added to cytology as a co-test for women 30 years and older increases the sensitivity of cytology and addresses many of its limitation, but also significantly contributes to the complexity of management. Additionally, it does not address the women 25-29 who are still screened with cytology alone. In ATHENA, 28% of all CIN3+ lesions detected were in women 25-29 -- more high-grade disease was found in these 6,647 women than in the 22,006 women 40 years and older. Further, cytology-based screening, the only other option for women 25-29, was negative in more than 57% of these cases, suggesting that current screening with cytology is inadequate in identifying underlying CIN3+ lesions in this age group. This is highly relevant when assessing data from the National Cancer Institute's SEER Tumor Registry, which shows a sharp rise in the incidence of invasive cervical cancer between the ages of 25 and 34 years. Since the goal of cervical cancer screening is to prevent cervical cancer from developing, it important to identify high-grade cervical cancer precursors in women 25-29 years, so that the precursors can be treated prior to this up rise in cervical cancer incidence and cervical cancer may be prevented. As a solution, HPV DNA testing can be used as a first-line primary screen in women 25 and older to not only enhance screening sensitivity but also reduce the complexity of a co-test.