39 years old
Sees her practitioner on a regular basis
No prior abnormal cytology results
No prior HPV testing
Sooner rather than later
Pooled high-risk HPV-positive woman with normal Pap cytology
Claudia’s doctor recently became part of a regional pilot program to evaluate primary screening for high-risk HPV (hrHPV).
Her doctor explains that hrHPV testing is much more sensitive than Pap cytology. When a woman has a negative hrHPV test result, doctors can be very confident that cervical disease is not present. Cytology, on the other hand, is known to miss disease in some cases, and while many doctors rely on the technique, they know a negative Pap cytology result may not always be a reliable indicator of the absence of disease.
Claudia agrees to have the hrHPV test. Her doctor collects a liquid-based cytology (LBC) specimen for the hrHPV testing. Claudia’s hrHPV test results are positive for pooled hrHPV. Her doctor also receives hrHPV genotyping results as part of the pilot program; Claudia is negative for the HPV 16 and HPV 18 genotypes most strongly associated with the development of pre-cancerous lesions. To determine if any cervical cytologic abnormalities are present, the laboratory subsequently runs a Pap cytology test on Claudia’s liquid-based cytology specimen. The Pap cytology results are normal.
Claudia’s doctor is presented with inconclusive test results that make it difficult to make a clear plan to help manage her patient. In a hrHPV primary screening program, women like Claudia with a positive pooled hrHPV test and a negative Pap cytology test would be managed by more frequent follow up, possibly culminating with a colposcopy. This can mean additional visits for the patient and additional anxiety about test results. A colposcopy could help provide more clarity about any changes to her cervical tissue, but the procedure ultimately turns out to be unwarranted for most women. This is because most hrHPV infections do not persist and lead to precancerous dysplasia, but rather resolve on their own over time.
The pilot program protocol stipulates that women like Claudia, who have a positive hrHPV result and normal (negative) Pap cytology result, return for follow-up hrHPV testing at 12 months.
How biomarkers could help
Using a dual-stain p16/Ki-67 biomarker test instead of a Pap cytology test to triage Claudia’s initial HPV test result could potentially spare her the anxiety of protracted retesting and even the need for colposcopy. Because Pap cytology can sometimes miss disease, Claudia’s doctor would be much more confident in prescribing a plan to manage her.
The co-expression of p16 and Ki-67 is strongly linked to pre-cancerous changes in the cervix, so a negative result can indicate that such changes are not present. In this case, colposcopy would be unnecessary, and the patient can be followed up according to appropriate guideline screening intervals.
A positive p16/Ki-67 result, conversely, would warrant immediate colposcopy. This would also help Claudia and her doctor avoid retesting and the anxiety associated with inconclusive results.
Explore transforming HPV infections
Explore hrHPV primary screening
Explore p16/Ki-67 dual biomarker testing
- ACOG, ASCCP, ASCP, and ACS state that HPV DNA tests specific for HPV type 16 or HPV 16/18 can be used as an adjunct in women with negative Pap test results, but who have tested positive for hrHPV by an assay testing for 13 or 14 high-risk types, in women aged 30 years or older. 3, 4
- Moreover, new professional guidelines from ACOG, ASCCP, ASCP, and ACS suggest that women with normal cytology who are HPV type 16 or HPV 16/18 positive be referred directly for colposcopy.3, 4
Co-testing in women aged 30-65
The American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) jointly issued guidelines for the prevention and early detection of cervical cancer in March 2012. The American Congress of Obstetricians and Gynecologists (ACOG) issued a new practice bulletin on screening for cervical cancer in November 2012. The harmonized ACS, ASCCP, and ASCP guidelines, as well as the ACOG practice bulletin on screening for cervical cancer, state that co-testing using HPV testing in addition to a Pap test every 5 years is preferable to using a Pap test alone every 3 years for women ages 30–65 years.3, 4
Review detailed recommendations from the guidelines.
Role of genotyping when screening3, 4
ACOG, ASCCP, ASCP, and ASC now recommend that in women 30-65 years of age, individual genotyping for HPV 16 or HPV 16 and 18 be considered when women have a normal cytology (Pap test) result but have positive results on a test for “pooled” high-risk HPV types. As an alternative for managing these patients, the guidelines continue to offer the option of repeating Pap and HPV testing at a one-year interval.
- The guidelines suggest that women with normal cytology who are HPV 16+ or HPV 16/18+ be considered for immediate colposcopy.3, 4
- If women with normal cytology are HPV positive, but HPV 16 or HPV 16/18 negative, 12 month follow up with co-testing is recommended. 3, 4
Absolute risk of high-grade cervical disease in women with normal cytology
The cobas® HPV Test helps you adhere to the guidelines by providing pooled hrHPV results and identifying the individual presence of HPV 16 and HPV 18, the highest-risk genotypes.
Absolute risk of ≥CIN2 stratified by hrHPV status in the ATHENA NILM population5
Discover a woman's riskfor ≥CIN2 or find a lab near you that offers the cobas® HPV Test.