HPV MOLECULAR DIAGNOSTICS AND CERVICAL CYTOLOGY

Fuente: Prevalence
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Disclosures and Disclaimers

• I serve on a Merck Data and safety Monitoring Board (compensated)
• I have a non-disclosure agreement with Roche to help analyze data from the ATHENA trial.
• I have received HPV assays / testing for research from Qiagen and Roche at a reduced cost or no cost.
• The views expressed are my own and do not represent those of the ASCP or any other organization.

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Today's Talk

• Natural History of HPV: rational Basis for Cervical Cancer Prevention
• Evidence for HPV Testing in Screening
• Management of HPV-positive Women
• Reaching those who do not come through the clinic doors

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My Basic Principles of Screening

• The goal of screening is not to find disease. Most diseases are too rare to succeed. Rather, screening is to rule out diseases in the generally healthy population and identify a subset who need further evaluation. If the screen is good, the subset will be very enriched for disease, i.e. better PPV.
• In the case of cervical cancer prevention, we want a positive screen to identify those women who have or may develop CIN3, which can be treated before it becomes invasive. CIN3 itself is NOT disease; it is a marker of cancer risk.
• We want a negative screen to provide an acceptable degree of reassurance against cancer until the next screen.

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Why Not Genotype For All HPV Types?

• What would be done with knowing that a lesser oncogenic HPV genotype is present? Can you imagine giving the community physicians read out on 13 carcinogenic HPV genotypes?
• Most women (>80%) who test HPV pos/pos have a type-specific, persistent HPV infection (Castle et al, BMJ, 2009)
• Type-specific detection does not predict CIN2+ or CIN3+ better thahn pooled detection (Gage et al, JCM, 2011; Marks et al, JCM, 2012). HPV pos/pos is a very strong predictor of CIN3+ (Kjaer et al, JNCI, 2011)

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Final Comments

• Using HPV testing as the primary screen effectively rules out disease in most women and shifts the use of Pap testing from the entire population to the 5-15% of women who have the necessary cause of cervical cancer, HPV.
• Pap testing can be used among HPV-positive women to decide which women are in immediate need of colposcopy. Other biomarkers such asHPV 16/18 detection and in the future p 16 immunocytochemistry can be used to complement Pap testing to increase the sensitivity of disease detection among HPV positives.
• There is no proven benefit of HPV and Pap contesting versus HPV testing alone for screening.
• The biggest reductions in cervical cancer will be achieved by reaching underserved populations.