Article

Roche Cervical Cancer Solutions

Significant strides have been made in decreasing cervical cancer rates around the world. In fact, Member States of the World Health Organization (WHO) have adopted a number of decisions to advance global public health, including specific goals calling for the elimination of cervical cancer.

Still, this preventable disease is far too common. Cervical cancer is missed and diagnosis is often delayed. This is due to a number of factors. Too many women are not being screened regularly or go too long between well-woman exams. Conventional tests used for screening and management yield inconclusive results, which require waiting for a re-test or further procedures that may cause unnecessary worry or delayed diagnosis.

Roche has studied the science of Human Papillomavirus (HPV), the infection that causes over 99% of cervical cancers, to develop advanced solutions to find disease early, and prevent invasive cervical cancer from developing. Triage and diagnosis of pre-cancers using biomarker technology simplifies testing and ensures laboratories and doctors get clear, actionable information. Based on more definitive risk assessment, women can be given the right guidance and care at the right time, protecting them from the potential harms or over- or under-treatment.

Focusing on the science of HPV for solutions

 

HPV is very common and most women will be exposed to it at some point in their lives. Most HPV infections go away on their own, without causing any problems. When an HPV infection persists over time, it can cause abnormal cellular changes that may lead to cervical precancer or cancer. It is important to identify women at risk with a reliable, sensitive test such as HPV DNA, and then assess their risk with a specific, reliable test to rule in or rule out disease.

Individual results for HPV 16 and HPV 18 along with a pooled result for other high-risk HPV types
There are over 100 types of HPV
Some types are higher risk than others
Almost all cervical cancers are associated with 14 types of HPV
HPV 16 and HPV 18 are the highest risk types
HPV virus cells

2020 Guidelines of the American Cancer Society recommend cervical cancer screening with the HPV test every five years for women aged 25-65, as a preferred approach over Pap testing and combination Pap and HPV testing.1,3

 

These guidelines reflect the rapidly changing landscape of cervical cancer prevention in the United States and around the world, focusing on better outcomes, test efficiency and more simplified screening. Human papillomavirus (HPV) is the cause of nearly all cervical cancers. Primary HPV testing every 5 years is more effective than Pap cytology alone for cervical cancer prevention, and more efficient than co-testing, reducing the number of tests while providing comparable outcomes.2

Primary HPV testing is proven more accurate than the Pap test and improves the assessment of a woman’s individual risk for developing cervical cancer. Many countries have already evolved to primary HPV screening with cobas® HPV DNA, the first FDA-approved and CE-marked HPV test for primary HPV screening.

The cobas® HPV Test simultaneously determines a pooled result for 12 high-risk HPV genotypes and provides individual results for the highest risk genotypes: HPV 16 and HPV 18. This allows a more accurate and reliable determination of a woman’s individual risk of developing cervical cancer. Most professional medical societies and Ministries of Health are updating their country guidelines to include primary HPV testing.

Biomarker technology in triage adds a measurable indicator of transforming disease

Advanced biomarker–based testing for triage fills in the gaps left by Pap cytology and when Pap and HPV testing are used together by identifying clear evidence of cell transformation to precancer or cancer. Now available in the US and worldwide, CINtec® PLUS Cytology is the first FDA-approved triage test that uses objective biomarker technology to remove the uncertainty for women identified as at-risk by a positive HPV result. CINtec® PLUS Cytology uses an immunocytochemical dual-stain, to look for the simultaneous presence within a single cell of two biomarkers – p16 and Ki-67 – in a cervical cytology sample. The co-expression of biomarkers p16 and Ki-67 indicates an abnormality that provides definitive information to help differentiate which HPV positive women may benefit most from immediate intervention. Women who test dual-stain negative for p16 and Ki-67 show no signs of transforming infection, and can be given more time to allow their body to clear the virus, without intervention. The CINtec® PLUS Cytology test is performed on the same sample collected for a Pap or HPV test, eliminating the need for additional office visits or waiting time.

CINtec® PLUS uses an immunocytologic dual stain, to look for the simultaneous presence of biomarkers p16 and Ki-67

Biomarker technology for reliable disease confirmation in biopsy specimens

CINtec® Histology detects biomarker p16 in cervical biopsy preparation, providing visual confirmation of pre-cancerous lesions

As women positive for HPV are at greater risk for having or developing pre-cancerous cervical lesions, labs need a test they can rely on to find pre-cancerous lesions so they can be diagnosed and treated before they develop into invasive cancers. CINtec® Histology is an immunohistochemistry assay that detects the p16 biomarker in cervical biopsies. This advanced test plays a key role when a cervical biopsy is taken as a result of an abnormal cervical screening result by providing clear visual confirmation of cervical lesions due to transforming HPV infections. Clear objective evidence enables pathologists to conclusively diagnose cervical precancer, and improves reproducibility when interpreting equivocal findings, so they can deliver definitive results that help clinicians make informed decisions and ensure the right women receive the best possible treatment for this highly preventable disease.

It’s time to take the guesswork out of protecting women from cervical cancer

CINtec PLUS Cytology positive dual stain result showing co-expression of biomarkers p16 & Ki-67 immunocytochemistry

There has been good progress at protecting women from developing cervical cancer but we can all do better. Roche is dedicated to investing in advancements that will significantly improve prevention strategies and support global efforts to eradicate this disease. Our approach is always based on the strength of clinical evidence and insights to challenge the status quo. We are committed to providing effective and simple solutions that give doctors and labs the answers they need and women the protection and care they deserve.

Cervical cancer is still far too common

 

With vaccination, regular screening and treatment, cervical cancer is highly preventable, yet annually an estimated 570,000 women will develop the disease and some 311,000 will die from it.4 Recognised as one of the top causes of death for women around the world, most cases occur in countries that have not yet established systematic, organised HPV screening. However, even in the US, where access to screening and women's health care is widely available, there is still too high a prevalence of cervical disease. The American Cancer Society reports 13,800 new cases of invasive cervical cancer will be diagnosed in 2020, and approximately 4,290 women will die from the disease this year.5

 

Need to move past the status quo

 

Over the past several decades, screening strategies based on Pap cytology have saved millions of lives, but there is significant need for improvement. Abnormal Pap test results are common and women often endure repeat testing and waiting before they learn if cervical disease is present. 

Inconclusive screening results when HPV and Pap cytology are used together can sometimes lead to uncertainties and leave labs and healthcare providers without the evidence they need to make confident next step decisions. Roche is leading the next evolution in cervical cancer screening, triage and diagnosis to address these still unmet needs.

HPV Cervical Cancer – global statistics

References

  1. Fontham, Elizabeth et. al, Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society, CA Journal, July 30, 2020, https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21628 Accessed July 31, 2020
  2. Screening for Cervical Cancer in Primary Care: A Decision Analysis for the U.S. Preventive Services Task Force. Agency for Healthcare Research and Quality (US) Kim et. al., JAMA. 2018;320:706‐714 Accessed August 4, 2020. uspreventiveservicestaskforce.org/uspstf/document/modeling‐study/cervical‐cancer‐screening;
  3. Cervical Cancer Screening for Individuals at Average Risk:2020 Guideline Update from the American Cancer Society, Fontham et. al. accessed 3August2020 (https://acsjournals.onlinelibrary.wiley.com/doi/pdfdirect/10.3322/caac.21628)
  4. WHO, ICO. Human Papillomavirus and Related Diseases Report – WORLD Available here: http://www.hpvcentre.net/statistics/reports/XWX.pdf Last Accessed September 2015
  5. American Cancer Society 2020 https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html#:~:text=The%20American%20Cancer%20Society's%20estimates,will%20die%20from%20cervical%20cancer.