Cervical Cancer

Human papillomavirus (HPV), the link to cervical cancer

Cervical cancer is one of the most common cancers in women with more than 13,000 new case diagnosed annually in the United States.¹ The link between cervical cancer and HPV has become clear over the past few decades. It is well known that a persistent HPV infection with specific high-risk genotypes account for nearly all cases of cervical cancer.² It is important to screen for high-risk HPV infections that are at the greatest risk of progressing to cervical pre-cancer and cancer. Cervical cancer is nearly preventable with proper vaccination, screening, and treatment. Identifying women at risk, before disease develops, is an important part of prevention.

The Progression to Cervical Cancer

While most HPV infections resolve on their own, some HPV infections can progress to high-grade cervical intraepithelial neoplasia, CIN2 or CIN3. If left untreated, CIN2 or CIN3 can progress to cervical cancer years or decades after the initial infection.³

Early detection and treatment of precancerous lesions may prevent progression to cervical cancer.⁴

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References:

National Cancer Institute Cancer Stat Facts: Cervical Cancer. Available at https://seer.cancer.gov/statfacts/html/cervix.html. Accessed October 15, 2020.
Cancer Today, International Agency for Research in Cancer (IARC) GLOBOCAN 2018 Registry. Available at https://gco.iarc.fr/today/data/factsheets/cancers/23-Cervix-uteri-fact-sheet.pdf. Accessed October 20, 2020.
Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97(14):1072-1079.
Burd E. Human papillomavirus and cervical cancer. Clin Microbiol Rev. 2003; 16(1):1-17.

Early detection of human papillomavirus (HPV) can help protect cervical health

Not every woman with an HPV infection will develop cervical cancer. The ability to identify disease early in the screening process, and clearly stratify disease risk in HPV positive women can help guide patient management.

Identify women at greatest risk

For the last 50 years, Pap cytology screening has had a tremendous impact on women's health. Since its introduction, the use of regular Pap cytology screening, together with the diagnosis and treatment of precancerous lesions, has contributed to an 80% reduction in the incidence and mortality of cervical cancer in countries with systematic screening.¹

However, cervical cancer is nearly preventable with proper HPV vaccination, screening and treatment. To reduce the incidence and mortality rates, attention must focus in part on the screening, triage, and management of women found to be at risk for cervical cancer. New screening solutions are necessary to increase women's access and to implement more optimal prevention strategies.

The Roche Cervical Cancer Portfolio covers the entire spectrum of screening, triage, and diagnostic solutions. The molecular and biomarker-based tests bring greater diagnostic certainty to cervical cancer screening providing reliable results with the confidence and clarity needed to determine the right next steps for your patients.

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References:

National Cancer Institute. Cervical Cancer Screening (PDQ^®). Available at https://www.cancer.gov/types/cervical/hp/cervical-screening-pdq. Accessed October 19, 2020.

Know now if she is at risk for cervical cancer

The FDA-approved cobas^® HPV test, the first step in the Roche Cervical Cancer Portfolio, objectively identifies women at risk and improves detection of high-grade disease in a single round of screening, utilizing molecular diagnostic testing for the presence of HPV. This means you have a screening tool that can stratify a patient’s risk.

Flexible screening options for your patients
The cobas HPV test is the cervical cancer screening test approved for ASC-US reflex, co-testing, and primary screening, as well as for use with both types of specimen collection vials^1,2* giving you the flexibility to choose the best screening method for your patients.

^{SurePath™ is only available on cobas® 4800 System.}

Screen with confidence

The cobas HPV test is designed to help minimize the chance of false negatives and provide screening accuracy for all high-risk HPV genotypes.

The cobas HPV test offers:

Internal cellular control
Monitors the presence of human cells and confirms reaction completion to prevent false-negative results.

3 results in 1 test
Yields 3 results (HPV 16, HPV 18, 12 high-risk HPV pooled) in 1 test run, eliminating the need to reflex and giving you the information needed to make important clinical decisions.

No cross-reactivity
Demonstrates no cross-reactivity with low-risk HPV genotypes, helping to ensure that a positive result is a true positive.

HPV DNA detection
DNA is present and needed for the replication of the virus, when viral infections occur.³ DNA-based testing is supported by 25 years of data following millions of women.

The cobas^® HPV Test is one of 3 clinically validated tests in the Roche Cervical Cancer Portfolio covering the entire spectrum of screening, triage, and diagnostics solutions. Roche offers a comprehensive portfolio to help determine the individual level of risk a woman has so that you will know what to do next and when.

References:

cobas® HPV test. Package insert v17, US. Roche Diagnostics; 2018.
cobas® HPV for cobas® 6800/8800. Package insert v1, US. Roche Diagnostics; 2020.
Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Gynecol Oncol. 2015;136(2).

Know now if she is progressing toward cervical cancer

Not every HPV-positive woman will develop cervical cancer, so triage is necessary determine who is most at risk and will benefit from more immediate follow-up, and who is at low risk and can be given more time to clear the infection on her own. CINtec^® PLUS is a triage cytology test that helps stratify disease risk immediately, giving clinicians confidence when selecting the appropriate management for women at every level of risk.

Detect changes at the cellular level

The CINtec PLUS Cytology Test is a dual-stain biomarker-based cytology test FDA-approved for HPV primary screening and HPV-positive and Pap-negative co-testing results. It identifies abnormal cell in cervical cytology samples using p16 and Ki-67 biomarkers to detect transforming HPV infections.¹

Biomarkers provide objective interpretation of the drivers behind transforming HPV infection: co-expression of halting and progressive cells division. Co-expression of the two biomarkers, p16 and Ki-67, indicates the HPV is disrupting the cell cycle and has started cell transformation. This additional information may inform greater objective risk and disease stratification when screening for cervical cancer.

CINtec PLUS Cytology is approved as a triage with the cobas HPV Test:

For discrepant co-testing results of women ages 30-65 when a woman is HPV positive but has a normal Pap

^{* For HPV16/18+ use as additional information in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.}hr = high risk

In HPV primary screening of women 25-65

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CINtec PLUS Cytology provides a triage solution that informs better risk stratification for HPV positive screening results.

CINtec PLUS Cytology provides further risk stratification in 12 other HPV+ women

Risk of disease in Pap normal/HPV+ women (≥CIN2, age 30-65)

Increased testing sensitivity

CINtec PLUS Cytology finds disease earlier in the screening process

Percentage of disease detected with CINtec PLUS Cytology in Pap normal/HPV+ women (≥CIN2, age 30-65)

Know now if she has cervical precancer

Diagnosing cervical precancer with CINtec^® Histology

For women in need of a colposcopy, CINtec Histology provides a more objective interpretation of cervical biopsies that helps pathologists accurately identify more cervical disease. It is the only FDA-approved p16 biomarker test for clinical/IVD use in the evaluation of cervical biopsy specimens.²

The 3 tests in the Roche Cervical Cancer Portfolio bring greater diagnostic certainty to cervical cancer screening. Now you can provide reliable results with the confidence and clarity needed to determine the right next step for your patients.

References:

CINtec® PLUS Cytology. Package insert. Roche Diagnostics; 2020.
CINtec® Histology 510(k) [package insert v1, US]. Indianapolis, IN: Roche Diagnostics; 2017.

To learn more about the Roche Cervical Cancer Portfolio, please complete the each of the required fields (marked with an asterisk) and a Roche representative will contact you.