Cervical cancer

Cervical cancer, once a leading cause of death for women, has seen a significant reduction in the past four decades due to the widespread use of routine Pap tests and human papillomavirus (HPV) testing. Despite progress, as many as 50% of women with cervical cancer had a normal Pap result in the three to five years before their diagnosis,¹ underscoring the importance of continuous vigilant screening. Annually, 13,820 people are diagnosed with cervical cancer in the U.S., resulting in 4,360 deaths.²

While Pap cytology has been in use since 1928,³ recent technological advances in HPV testing have provided clinicians with the ability to identify patients at higher risk of cervical cancer based on their HPV genotype.

More than nine out of every 10 cases of cervical cancer are caused by HPV.⁴ While more than 80% of women and men acquire HPV by age 45, HPV infection has no age limit.⁵ Diagnostic testing remains crucial, especially since not every HPV-exposed woman returns for subsequent testing. Recognizing this challenge, Roche Diagnostics, committed to shaping a future with longer, healthier lives, offers a comprehensive FDA-approved Cervical Cancer Portfolio. Our innovative solutions aim to address screening limitations, enabling earlier diagnosis and treatment that prioritize patient well-being.

Advances in cervical cancer screening and triage

Our cobas® HPV test can detect high-risk HPV genotypes, including HPV-16 and HPV-18 and 12 other pooled genotypes. And, women and people with a cervix can collect their own vaginal sample in a healthcare setting to make HPV testing for cervical screening more comfortable and accessible.*

A more recent innovation, the dual-stain triage technology, can detect the transformation of HPV-infected cells into precancer. For example, in a dual-stain biomarker triage test, p16 is a biomarker that occurs in normal cells and signifies cell cycle arrest. Ki-67 is also a biomarker that occurs in normal cells and signifies cell cycle division. A new test can identify when both biomarkers are present at the same time, indicating that HPV is disrupting the cell cycle and the cell has started to transform.

The American Society of Colposcopy and Cervical Pathology, also known as ASCCP, took a historic step in March 2024 by including dual-stain technology in its Enduring Guidelines to help clinicians to triage patients who are positive for the types of HPV that have higher risks of developing cervical cancer.

Early detection significantly improves the five-year survival rate, which is 91% for women with invasive cervical cancer when identified early.⁶

*Roche’s HPV self-collection is FDA-approved and is expected to be commercially available in Q4 2024.

References

ncbi.nlm.nih.gov. Last accessed August 6, 2024
Cancer.gov. Last accessed January 2, 2024.
Pubmed.gov. Last accessed January 2, 2024.
Cdc.gov. Last accessed January 5, 2024.
Pubmed.gov. Last accessed January 5, 2024.
Cancer.gov. August 6, 2024.

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Only the Roche Cervical Cancer Portfolio covers the entire spectrum of screening, triage and diagnostic testing.

Cervical Pap smear tests have evolved to detect potentially precancerous and cancerous processes in the cervix. While Pap cytology has played a crucial role, recent technological advancements, including HPV testing, provide better insights into patients' HPV genotypes and identify those at higher risk.

Featuring molecular and biomarker-based tests, our portfolio offers enhanced diagnostic certainty in cervical cancer screening. These advanced tests provide guidance to clinicians and women at every stage of the screening process, eliminating the ambiguity associated with current testing approaches.

Adapting to evolving medical guidelines, the Roche Cervical Cancer Portfolio accommodates various approaches, including co-testing, human papillomavirus (HPV) primary screening, HPV self-collection* and the more recent dual-stain triage technology. This versatility ensures that the Portfolio remains at the forefront of supporting current and emerging best practices in cervical cancer screening and diagnosis.

*Roche’s HPV self-collection is FDA-approved and is expected to be commercially available in Q4 2024.

cobas HPV test supports clinicians’ screening methods

A screening tool exists that can stratify a woman's risk for cervical cancer. The cobas® HPV test is the first HPV test approved for all three screening options and collection vials, Thinprep and Surepath.*

The cobas HPV test objectively identifies women at risk and improves the detection of high-grade disease in a single round of screening, utilizing molecular diagnostic testing for the presence of HPV.

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 giving healthcare providers the flexibility to choose the best screening method for patients.^3,4

The cobas HPV test is one of the first HPV self-collection solutions approved in the U.S. In a healthcare setting, women or people with a cervix collect their own vaginal samples, which are then sent to a laboratory for analysis with Roche’s cobas molecular instrument.**

Screen with confidence

The cobas HPV test is specifically designed to enhance screening accuracy by minimizing the risk of false negatives across all high-risk HPV genotypes. Providing three results in one test, it covers the 14 types of high-risk HPV genotypes associated with cervical cancer, including specific results for HPV 16, HPV 18, and 12 other pooled genotypes. This comprehensive approach furnishes essential information for critical clinical decisions.

To prevent false-negative results, the test monitors the presence of human cells and confirms the completion of reactions. It also demonstrates no cross-reactivity with low-risk HPV genotypes, ensuring that a positive result is truly positive. The reliance on DNA-based testing is backed by 25 years of data, derived from millions of women, supporting the importance of DNA in viral infection replication.⁵

CINtec PLUS is a triage cytology test

Cervical Pap smear tests have evolved to detect potentially precancerous and cancerous processes in the cervix. While Pap cytology has historically played a crucial role, recent technological advancements include HPV testing, provide better insights into patients' HPV genotypes and identify those at higher risk of cervical cancer.

The emergence of dual stain technology allows for the detection of HPV-infected cell transformation into precancer. Early detection significantly improves the five-year survival rate for invasive cervical cancer, reaching 92%.⁶ The FDA-approved CINtec® PLUS Cytology dual-stain biomarker triage test, introduced in 2020, stands as the sole commercially available product in this innovative category.

Detect changes at the cellular level

The CINtec PLUS Cytology test is the only 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 cells in cervical cytology samples using p16 and Ki-67 biomarkers to detect transforming HPV infections.⁷

Biomarkers provide an objective interpretation of the drivers behind transforming HPV infection: co-expression of halting and progressive cell division. Co-expression of the two biomarkers, p16 and Ki-67, indicates that 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.

<h4>CINtec <i>PLUS</i> Cytology is approved as a triage with the <b>cobas</b> HPV Test:<sup>1</sup></h4><div> </div>

CINtec PLUS Cytology is approved as a triage with the cobas HPV Test:¹

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

In HPV primary screening of women ages 25 to 65

The American Society of Colposcopy and Cervical Pathology, also known as ASCCP, took a historic step in March 2024 by including dual-stain technology in its Enduring Guidelines to help clinicians triage women and people with a cervix who are positive for the types of HPV that have higher risks of developing cervical cancer.¹⁹

CINtec Histology can diagnose cervical cancer

CINtec® Histology is the only FDA-approved p16 biomarker technology that can help pathologists evaluate cervical biopsy specimens that can confirm the presence of precancerous cervical lesions.⁸

For patients in need of a colposcopy, CINtec Histology provides a more objective interpretation of cervical biopsies and, in one trial, decreased potentially false negative results by 43%.⁷

Our test detected 85 out of 100 biopsies with the disease compared to 73 out of 100 with hematoxylin and eosin stains.⁷

IMPACT Trial

Recognizing the existing health disparities in cervical cancer, particularly affecting Black and Hispanic-Latina women, the IMPACT Trial design validated the clinical benefits of the cobas HPV Test, CINtec PLUS Cytology test and CINtec Histology.¹

This study deliberately included diverse patient segments, with 21% Black, 24% Hispanic-Latina, and 0.3% American Indian or Alaskan Native participants.² By incorporating this diversity into clinical trials, Roche aims to accurately reflect patient populations with higher incident rates of HPV, contributing to efforts to address health disparities in cervical cancer.

In the trial, CINtec PLUS Cytology detected cervical disease earlier in seven out of 10 women who were already identified as HPV positive.⁷ 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.

*Surepath is only available on the cobas 4800.

**Roche’s HPV self-collection is FDA-approved and is expected to be commercially available in Q4 2024.

References

Centers for Disease Control. Last accessed January 2, 2024.
Wright TC Jr, Stoler MH, Ranger-Moore J, Fang Q, Volkir P, Safaeian M, Ridder R. Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial. Int J Cancer. 2021 Sep 18. doi: 10.1002/ijc.33812. Online ahead of print.
cobas® HPV test package insert.
cobas® HPV Test for cobas® 6800/8000 package insert.
Doorbar J, Quint W, Banks L, Bravo IG, Stoler M, Broker TR, Stanley MA. The biology and life-cycle of human papillomaviruses. Vaccine. 2012 Nov 20;30 Suppl 5:F55-70. doi: 10.1016/j.vaccine.2012.06.083. PMID: 23199966.
Cancer.net. January 2, 2024.
CINtec® PLUS Cytology package insert.
CINtec® Histology 510(k) package insert.

Every two minutes, a woman dies of cervical cancer, which is preventable.¹

Cervical cancer is one of the most preventable cancers today due to vaccination, screening and early treatment. Yet it is still responsible for thousands of deaths each year.²

Unlike most cancers, cervical cancer is caused by an infection – human papillomavirus (HPV).³

Four out of five women will be infected with HPV at some point in their lives.⁴ Most of the time, HPV infections clear naturally and do not cause cancer. While there are more than 200 different strains of HPV,⁵ there are 14 genotypes that are most commonly associated with cervical cancer.

What is cervical cancer?

Cervical cancer is cancer of the cervix. The cervix is located at the lowest part of the uterus. A persistent or long-term infection of certain high-risk HPV types is the primary cause of cervical cancer. When found early or in the pre-cancer stage, treatment can be successful. Cervical cancer is highly preventable with vaccination and regular screening.⁶

What is HPV?

The HPV is the most common sexually transmitted infection. HPV is so common that nearly all sexually active adults, regardless of birth-assigned sex or gender identity, will have at least one HPV infection at some point in their lives. Most HPV infections have no signs or symptoms and are cleared by the body’s immune system.⁷

What is primary screening?

Primary HPV screening is when an HPV test is administered without another test.¹⁷

Is cervical screening covered by insurance?

Regular screenings for HPV – no cost for most under the Affordable Care Act – can lessen the chances of cervical cancer developing.¹⁸

Screen

Results

Diagnosis

Action

The importance of cervical cancer screening

Screening is key to reducing the risk of developing cervical cancer. All women above age 21,¹⁶ or once sexually active, need cervical cancer screening, no matter their sexual orientation, relationship status or HPV vaccine status.⁹

There are two options healthcare providers use to screen: the Pap and HPV tests. The two screening options can be done together or independently, depending on age or medical history and the doctor’s recommendation.

Pap test

A Pap test looks for abnormal cells on the cervix that can indicate early signs of cancer.

The Pap test has been in use for around 80 years; it looks for abnormal cells growing on the cervix that can be early signs of cancer. A healthcare provider collects cell samples from the cervix and sends the sample to a laboratory for examination under a microscope by a trained professional. However, a normal Pap result does not always mean cancer-free: Up to one-third of cervical cancers occur in women with a normal Pap.¹⁰

HPV test

An HPV test detects high-risk human papillomavirus.

An HPV test detects the DNA of high-risk HPV at infection that may lead to high-grade cervical disease or precancer. The sample needed for an HPV test is taken from the cervix by a healthcare provider in the same way as the Pap test. Women and people with a cervix also may have the option of taking their own vaginal sample in a healthcare setting to make HPV testing for cervical screening more comfortable and accessible. Samples taken by a clinician or by the women being screened are then sent to a lab to be tested for high-risk HPV on an automated instrument using molecular technology. HPV tests give an early, accurate look at cervical cancer risk.

The difference between the two screening tests is the Pap test looks for changes in cells before they develop into cancer.

The HPV test looks for high-risk HPV genotypes to better manage risk for cervical cancer. Receiving an HPV test can better predict one’s risk of cervical cancer.

Roche offers the cobas® HPV test. The test is used in cervical cancer screening to determine a woman's risk of precancer or cancer. The test provides individual results for high-risk HPV genotypes 16 and 18 and a combined result for 12 other high-risk genotypes.

Screening recommendation by age:¹⁶

Understanding HPV screening results

Testing positive for HPV is not a reflection of sexual behavior or lifestyle, and it can happen in a monogamous relationship, as the virus can go undetected for years. Most HPV infections have no signs or symptoms and are cleared by the body’s natural immune system.⁴ A positive result does not mean one will have or will develop cervical cancer, but it does mean there’s an increased risk.¹¹

There are five potential combinations of cervical screening results:¹¹

<h5>Pap test (cervical cytology) results</h5> <p> </p>

Pap test (cervical cytology) results

Normal Pap no cell changes were found on the cervix

There is a low chance of developing cervical pre-cancer or cancer; one should have another screening test in 3 years.

Pap unclear

An unclear pap is also known as ASC-US, atypical squamous cells of undetermined significance. Some cells on the cervix do not look normal, but the changes do not clearly suggest a precancerous lesion. Your doctor may recommend an HPV test to find out if the cell changes are related to HPV.

Pap abnormal cell changes were found on the cervix

The changes may be minor (low-grade) or moderate to severe (high-grade). This does not mean one has cervical cancer. Most of the time, minor changes go away on their own. However, more severe changes may result in cervical cancer if not treated. The doctor may suggest an HPV test or colposcopy to help determine the next steps.

<h5>HPV test results</h5> <p> </p>

HPV test results

HPV negative

There is no HPV infection, and the risk is low for developing cervical pre-cancer or cancer in the next 5 years.

HPV positive

There is a high-risk HPV infection and an increased risk of cervical pre-cancer or cancer. The doctor may suggest waiting a year before retesting to allow the body more time to clear the infection, request additional testing to see if the cells are changing, or recommend a colposcopy to help determine the next steps. It is important that one returns for a follow-up visit.

Receiving a positive HPV diagnosis

Most women who are HPV-positive will not develop cervical cancer.¹¹

Triage typically occurs when women test positive for high-risk HPV genotypes. Common high-risk genotypes are HPV 16 and HPV 18, which account for 66% of cervical cancer.¹² The other high-risk genotypes are: 31, 33, 45, 52 and 58.¹³

After receiving a positive result for a high-risk HPV genotype, there are different steps that can be taken^.14

Some healthcare providers may suggest waiting another year to see if the infection will clear on its own.
A healthcare provider could request that the sample be sent for a triage test to know if the infection is progressing.
With certain types of high-risk HPV, a healthcare provider may want to biopsy to see if pre-cancer or cancer is present.

Roche’s CINtec® PLUS Cytology is a triage cytology test that helps stratify disease risk immediately. The dual-stain test gives women better information about whether their HPV infection is transforming into pre-cancer without having to wait a potentially anxious year for re-testing.

What is triage?

Triage refers to the process of sorting people based on whether one may benefit from an immediate intervention or can be allowed more time before follow-up or retesting. In the case of cervical cancer screening, it may be recommended that women who receive a positive high-risk HPV and/or abnormal Pap result are managed more closely with follow-up care or testing.¹⁵

How do HPV genotypes help?

Genotypes can help doctors manage risk for their patients. An HPV genotype result can indicate if a patient has a higher risk of developing cervical cancer. Common high-risk genotypes are HPV 16 and HPV 18.¹⁵

What is dual-stain?

Dual-stain identifies abnormal cells through biomarker staining of cervical cells collected during routine cervical-cancer screening. It uses two biomarkers – p16 and Ki-67 – that when found together, signal changes at the cellular level that indicate a transforming HPV infection.

Take action

Cervical cancer prevention begins by being proactive. Vaccination and regular screening are important as they have been shown to prevent cancer and save lives. Ensuring everyone has access to cervical cancer screening is key to eliminating the disease.

Every woman should feel encouraged to talk openly with their doctor regarding available screening options and the recommended frequency for cervical cancer screening. No one should feel shame or embarrassment about discussing topics related to HPV or cervical cancer. Promoting awareness, accessibility, and destigmatization, communities can work together to prioritize early detection and prevention to help women everywhere.

Disclaimer: This content is provided for educational and informational purposes only and does not constitute providing medical advice or professional services. The information provided should not be used for diagnosing or treating a health problem or disease, and those seeking personal medical advice should consult with a licensed physician. Always seek the advice of your doctor or another qualified health provider regarding a medical condition.

References

Cervicalcanceraction.org. Last accessed August 2, 2024.
Cancer.org. Last accessed August 2, 2024.
Cdc.gov. Last accessed August 2, 2024.
Cdc.gov. Last accessed August 2, 2024.
Nih.gov. Last accessed August 2, 2024.
Cancer.gov. Last accessed August 2, 2024.
Cancer.gov. Last accessed August 2, 2024.
Cancer.gov. Last accessed August 2, 2024.
Ncbi.gov. Last accessed August 2, 2024.
Ncbi.gov. Last accessed August 2, 2024.
Cdc.gov. Last accessed August 2, 2024.
Cdc.gov. Last accessed August 2, 2024.
Cancer.gov. Last accessed August 2, 2024.
Cancer.gov. Last accessed August 2, 2024.
Ncbi.gov. Last accessed August 2, 2024.
Uspreventiveservicestaskforce.org. Last accessed August 2, 2024.
Cancer.gov. Last accessed August 2, 2024.
Hrsa.gov. Last accessed August 2, 2024.
ASCCP.org. Last accessed August 2, 2024.

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