Roche Cervical Cancer Portfolio

The Roche Cervical Cancer Portfolio gives you clearer, more definitive answers to help inform your patient care and management decisions.

The Roche Cervical Cancer Portfolio is a powerful combination of clinically validated tests that simplify prevention and management, while providing unprecedented efficiency to the process for risk assessment. Our cervical cancer product portfolio is rooted in science, consisting of molecular, cellular and tissue-based HPV screening and diagnostic tests.

Be confident: HPV DNA screening identifies more women at risk of cervical cancer

The cobas^® HPV test is the first clinically validated, FDA-approved, CE-IVD marked HPV DNA test for primary cervical cancer screening, ASC-US triage, and co-testing.

The cobas^® HPV test provides pooled results on known high-risk HPV genotypes, and simultaneous individual results from the two highest-risk HPV genotypes: HPV 16 and HPV 18, all from a single sample. This combination of results allows you to make clear, accurate, actionable patient care decisions.

All women deserve the most accurate screening test science can give them for protection from cervical cancer

Since the 1940’s, Pap cytology has revolutionized cervical cancer prevention, but cancer rates are no longer declining. Furthermore, Pap cytology’s accuracy is related to a woman’s age–in Roche’s ATHENA trial, Pap missed 56% of disease in women ages 25-29. Missed or delayed detection of progressing disease may result in invasive treatments, including hysterectomy.

The time for HPV screening advancement is here. Modern technology using HPV DNA testing identifies the cause of >99% of cervical cancer¹, enabling greater confidence for clinicians and their patients. The cobas^® HPV test was proven to be the superior predictor of cervical cancer risk compared head-to-head with Pap cytology in the ATHENA trial.^2,3

cobas^® HPV test provides clear answers to two questions:

• Is the cause of cervical cancer present?
• Who is safe enough to return to routine screening?

cobas^® HPV test offers:

• Reduced false negatives with ß-globin internal control for sample adequacy
• Reduced false positives with external control and no cross-reactivity with low-risk HPV genotypes
• Results are positive, negative, or invalid with no gray zone
• Reproducible results with real-time PCR

CINtec^® PLUS Cytology: optimizing triage in cervical screening

The goal of screening is to avoid misdiagnosis and the over- or under-treatment it causes. CINtec^® PLUS Cytology gives a simple, objective result physicians can use to manage their patients accurately. CINtec^® PLUS Cytology:

• Helps ensure women are not lost to follow-up
• Reduces both the number and frequency of follow-up visits required
• Gives women clear answers and certainty in their test results

CINtec^® PLUS Cytology, used in combination with the cobas^® HPV test and CINtec^® Histology, offers clinicians and labs powerful support to aid clinical patient care decisions for women identified as at-risk for cervical disease. The dual-stain biomarker technology included in the CINtec^® PLUS Cytology test detects the simultaneous presence within a single cell of the two biomarkers -- p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease.

The ability of CINtec^® PLUS Cytology to distinguish those women who are at higher risk for cervical disease provides labs, clinicians and women, in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines information, to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money.

Morphology based diagnosis with Pap cytology is subject to interpretive variability and lacks diagnostic accuracy. HPV DNA testing is the most sensitive screening method, but diagnostic accuracy improves with triage testing of HPV positive test results. In short, clinical outcomes improve when the cobas^® HPV test and CINtec® PLUS Cytology are used together.

Performance of cobas^® HPV and CINtec^® PLUS Cytology (≥CIN3; age 25+)

Sources: Wright et al., Gyn Oncol 2017. Castle, P.E., Stoler, M.H., Wright, T.C. Jr., et al. (2011). Lancet Oncology, 12, 880-890.
*cobas^® HPV 16/18 genotyping and CINtec^® PLUS Cytology triage of women with other 12 hrHPV

CINtec^® PLUS Cytology can objectively triage abnormal cytology screening results

Identify women with transforming HPV infections who have ASC-US or LSIL Cytology screening results and will benefit most from immediate colposcopy follow-up.

CINtec^® PLUS Cytology outperforms Pap cytology as the triage test for HPV(+) screening results

Improved cervical cancer screening strategy: HPV primary screening with the cobas^® HPV DNA test. Triage HPV(+) results with the CINtec^® PLUS Cytology test demonstrates high sensitivity and specificity to detect transforming HPV infections and helps avoid unnecessary colposcopy for women who do not need it.

*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.

Triage of HPV(+) screening results: CINtec^® PLUS Cytology vs. Pap Cytology

CINtec^® Histology: Be conclusive in diagnosing cervical precancer

CINtec^® Histology provides objectivity to diagnostic interpretation that helps all pathologists identify more cervical disease. The CINtec^® Histology test is the only p16 biomarker test CE marked and U.S. 510(k) cleared for clinical use in the evaluation of cervical biopsy specimens. Pathologists who use CINtec^® Histology demonstrate improved diagnostic consistency and diagnostic agreement between each other and with expert gynecopathologists.¹

CINtec^® Histology enhances identification of occult lesions that may be missed by H&E or morphologic interpretation alone, adding objectivity to cervical biopsy interpretation to help pathologists make informed diagnoses. The adjunctive use of CINtec^® Histology helps pathologists ensure the right patient is treated without unnecessarily treating more patients.

Source: CINtec^® Histology IFU 2017. Results based on the percent agreement of the majority of pathologists with expert pathologists when all pathologists use H&E along with CINtec^® Histology for diagnosing ≥CIN2.

Diagnostic sensitivity improves by 11.8% and specificity improves by 9.7% to identify high-grade cervical disease¹

Diagnostic consistency for high-grade disease of challenging cases by the majority of pathologists improves by 29.5%¹

Pathologists who use CINtec^® Histology demonstrate improved diagnostic consistency with each other and with expert gynecopathologists.¹