HPV vaccination is the primary prevention method for cervical cancer.
Learn More by reading the WHO position paper on HPV vaccination.
HPV DNA screening identifies women at risk for cervical cancer with greater sensitivity than Pap (smear) cytology alone, and screening with the cobas® HPV test not only finds more high-grade disease than a Pap test alone but also helps maintain screening efficiency. 3-in-1 results can be reported simultaneously for HPV 16, HPV 18 and the other 12 high-risk types to further stratify patinets according to risk, helping guide next step, follow-up care recommendations.
The feasibility of cytopathology was introduced in the 1940's, and since then, use of the Pap test for screening of asymptomatic women has contributed to an estimated 70% decrease in the rates of cervical cancer by detecting cellular abnormalities.2 However, due to Pap’s low sensitivity for the detection of precancerous cervical lesions,3 highly variable results between trained professionals across different laboratories,4 and poor detection of adenocarcinoma,5 it has significant limitations as a long-term, global solution for identifying women at risk for cervical disease.6
Watch this 4:20 video on how HPV influences oncogenic transformation and how the Roche Cervical Cancer Portfolio can help you optimally screen, triage and diagnose your patients.
To improve on the low sensitivity of Pap cytology alone for cervical cancer screening, HPV co-testing is an option that relies on Pap cytology and HPV together. While the practice of co-testing has shown to be the most effective at detecting precancer and cancer of the cervix, 7,8 it is because the HPV test adds the greatest benefit with Pap cytology adding marginal benefit. As a result, it is inefficient from a cost standpoint for resource-limited countries to adopt. When HPV genotyping information is included as part of the HPV test result, women can be further risk stratified. One in 10 women positive for HPV 16 and/or HPV 18 have high-grade disease that is missed by cytology alone.9
HPV primary screening algorithms often include Pap cytology as an appropriate triage. However, next generation tests that rely on dual-stain biomarker technology offer significant advantages over this traditional approach. Rather than looking for cellular changes that are morphologic, and may be missed due to their subjectivity, results based on the simultaneous expression of p16 and Ki-67 in a single cell indicates more definitively and objectively that an HPV infection shows signs of oncogenic transformation.
CINtec® PLUS Cytology is an FDA approved, CE-IVD marked objective biomarker dual stain test for p16 and Ki-67. It can be used to triage positive HPV primary screening results, and helps resolve discrepant co-testing (HPV positive/Pap NILM - Negative for Intraepithelial Lesion or Malignancy), ASC-US cytology (Atypical Squamous Cells of Undetermined Significance) or LSIL (Low-grade Squamous Intraepithelial Lesion) findings. If p16 and Ki-67 are found together in the same cell, it indicates an HPV infection is causing cellular changes that may progress to cervical precancer or cancer. This information helps clinicians be certain about which patients may benefit from a more immediate colposcopy, and which patients may be allowed more time for an HPV infection to resolve, before repeat screening.
CINtec® PLUS Cytology is the first approved biomarker triage test that uses dual-stain technology to simultaneously detect p16 and Ki-67; if found together in a single cell, a positive dual-stain test is a strong indicator that an HPV infection is starting to cause cellular changes that may progress to cervical precancer or cancer.
Some countries may utilize HPV genotyping to triage their Pap cytology or co-testing results. HPV genotyping information further stratifies a woman's risk, to help guide patient care decisions.
HPV genotypes 16 and 18 account for nearly 70% of all cases of cervical cancer10. Focusing on these genotypes gives clinicians useful details to aid treatment decisions. HPV genotype 16 confers a higher risk of having precancerous lesions and cervical cancer than other genotypes, while HPV genotype 18 was found in 31.6% of cases associated with adenocarcinoma of the cervix.11 Atypical glandular cells, the precursor to adenocarcinoma of the cervix are more difficult to detect with Pap cytology.12
Analysis of cervical biopsies using H&E or morphologic interpretation alone may lead to false-negative and false-positive results, resulting in missed disease or unnecessary referral for excisional procedures.
Adjunctive interpretation of a p16 immunohistochemistry stain, along with the H&E, increases diagnostic agreement between pathologists. The CINtec® Histology test is the only p16 biomarker FDA cleared for clinical/IVD use in the evaluation of cervical biopsy specimens. When experts use CINtec® Histology, 23.8% more high grade cervical disease may be identified compared to H&E (hematoxylin and eosin) alone14.
Colposcopy is done when results of cervical cancer screening or triage tests show abnormal changes in the cells of the cervix, or if a woman tests positive for one of the highest risk types–HPV genotype 16 or 18. Professional guidelines from ASCCP, ASCP, and ACS suggest that women with normal cytology who are HPV 16 or HPV 18 positive be considered for immediate colposcopy.
Sometimes a biopsy is performed during colposcopy to collect tissue samples from areas that look suspicious. The diagnostic information from the cervical biopsy specimen helps drive patient care or treatment decisions. These samples are sent for laboratory analysis by a pathologist to detect cervical cancer precursors.