New mRNA cervical screening program could help reduce health care costs in Canada and help women avoid unnecessary testing and follow-up

Economic model shows mRNA HPV test for cervical screening could eliminate tens of thousands of tests and procedures annually 

MISSISSAUGA, ON, Oct. 26, 2021 /CNW/ - A new health economic model developed by Aquarius Population Health and recently published in Preventive Medicine Reports shows that if an mRNA human papillomavirus (HPV) test were implemented in Ontario as part of a cervical cancer screening program in place of a DNA test, it could save the province over $4 million annually and avoid unnecessary colposcopies and additional screening tests. The model was a simulation of the impact of the proposed primary HPV screening program developed for Ontario that compared using two different types of high-risk HPV tests: mRNA and DNA-based tests. ¹

Cervical cancer is primarily caused by persistent genital infection with high-risk HPV.² HPV can be detected using either mRNA or DNA-based HPV tests, but mRNA tests are more specific at detecting active infections resulting in less false positive results.^3,4 This increased specificity is responsible for the reduction in unnecessary colposcopies and testing, which can reduce unnecessary anxiety in women around false positive test results.^5,6  

"Canada aims to achieve the goal of eliminating cervical cancer by 2040 and that goal is within reach," said Dr. Elisabeth Adams, Managing Director and Founder of Aquarius Population Health. "Using these findings, governments across the country have the opportunity to create safe, efficient and cost-effective screening programs that will help to drive down cervical cancer rates even further towards that goal."

Cases of cervical cancer in Canada have decreased in recent years as a result of Pap test/cytology-based screening programs.⁷ However, cervical cancer remains a relatively common yet preventable cause of cancer in women.1 Last year, the Canadian Partnership Against Cancer called on health care partners and communities across Canada to end cervical cancer in Canada by 2040.⁸ This led to the development and implementation of the Canadian government's plan to achieve the World Health Organization's elimination goal in this country.⁹

Since 2012, current guidance in Ontario has recommended cytology primary screening.1 However, as cervical cancer is primarily caused by persistent genital infection with high-risk HPV, Ontario has been evaluating the implementation of HPV-based testing in cervical screening.¹⁰

About the study

• The study, A health economic model to estimate the costs and benefits of an mRNA vs DNA high-risk HPV assay in a hypothetical HPV primary screening algorithm in Ontario, Canada, was published in the September 2021 edition of Preventive Medicine Reports. This is an independent study supported by funding from Hologic, Inc.¹
• An HPV primary algorithm adapted from the Cervical Screening Programme in England was simulated in a decision tree model, as it is comparable to the primary HPV algorithm proposed by the Cervical Screening Guideline Working Group in Ontario.¹¹
• When running an HPV primary screening algorithm, cervical samples were first tested for high-risk HPV. Positive HPV samples were then tested with cytology and referred to colposcopy if abnormal cells were found. Those with HPV positive results and negative cytology were recalled for a follow-up 12 months later.¹ One cohort of 2.25 million women in Ontario between the ages of 30-65 years participating in cervical cancer screening was followed from the baseline screen through to recall visits. The model endpoint was discharge to routine recall, loss-to-follow-up, or referral to colposcopy.¹

About Cervical Cancer in Canada
Each year in Canada, more than 1,300 women are diagnosed with cervical cancer and over 400 die from the disease.¹² Almost all cases of cervical cancer are caused by HPV¹³, which is preventable through the HPV vaccine. The publicly funded vaccine is provided to male and female students in every province and territory through school-based programs.¹⁴ Regular screening of adult women is also vital as cervical cancer caught at an earlier stage has a high survival rate.¹⁵

About Hologic
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

About Aquarius Population Health
Aquarius Population Health is an independent research firm that delivers key insights to drive evidence-based decision making in healthcare delivery and patient care.  They specialise in evaluating the health economics and impact of implementing healthcare products and services.

1. Weston G, Dombrowski C, Steben M, Popadiuk C, Bentley J, Adams EJ. A Health Economic Model to Estimate the Costs and Benefits of an MRNA vs DNA High-Risk HPV Assay in a Hypothetical HPV Primary Screening Algorithm in Ontario, Canada. Preventive Medicine Reports, 2021;23:101448

2. Waller J, Marlow L A V, Wardle J. The Association between Knowledge of HPV and Feelings of Stigma, Shame and Anxiety. Sexually Transmitted Infections,2007;83 (2):155–9

3. Aptima HPV assay [package insert]. AW-18573 001. San Diego, CA; Hologic, Inc., 2020. Table #13

4. Iftner T, et al. The Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany. J Clin Microbiol. 2019:57(1):e01177-18. doi:10.1128/JCM.01177-18 (GAST trial).

5. Monsonego J, et al. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based

cytology in primary cervical cancer screening: the FASE study. Intl J Cancer. 2011;129(3):691-701.

6. Darrel A. Cook, Laurie W. Smith, Jennifer Law, Wendy Mei, Dirk J. van Niekerk, Kathy Ceballos, Lovedeep Gondara, Eduardo L. Franco, Andrew J. Coldman, Gina S. Ogilvie, Dan Jang, Max Chernesky, Mel Krajden, Aptima HPV Assay versus Hybrid Capture® 2 HPV test for primary cervical cancer screening in the HPV FOCAL trial, Journal of Clinical Virology, Volume 87, 2017, Pages 23-29, ISSN 1386-6532, https://doi.org/10.1016/j.jcv.2016.12.004.

7. Vaccarella S, Lortet-Tieulent J, Plummer M, Franceschi S, Bray F. Worldwide Trends in Cervical Cancer Incidence: Impact of Screening against Changes in Disease Risk Factors. European Journal of Cancer, 2013:49 (15):3262–73.

8. Canadian Partnership Against Cancer. Canada Acts to Meet WHO Call to Eliminate Cervical Cancer https://www.partnershipagainstcancer.ca/news-events/news/article/eliminate-cervical-cancer/. Last accessed 10 Aug 2021.

9. Canadian Partnership Against Cancer. Action Plan for the Elimination of Cervical Cancer in Canada, 2020–2030 . https://www.partnershipagainstcancer.ca/topics/elimination-cervical-cancer-action-plan. Last accessed 10 Aug 2021.

10. Cancer Care Ontario. Cervical Screening Guidelines Summary. June 2020. https://www.cancercareontario.ca/en/guidelines-advice/cancer-continuum/screening/resources-healthcare-providers/cervical-screening-guidelines-summary. Last accessed 10 Aug 2021.

11. Weston G, Steben M, Popadiuk C, Bentley J, Dombrowski C, Adams E. Estimating the costs and benefits of HR-HPV assay choice in a theoretical HPV primary cervical screening algorithm in Ontario, Canada. Poster presented at: EUROGIN International Multidisciplinary HPV Congress; 2021 May 30 – June 1; Virtual.

12. Public Health Agency of Canada. Cervical Cancer. 2 March 2009. https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/cervical-cancer.html. Last accessed 1 September 2021.

13. Centers for Disease Control and Prevention. Cancers Associated with Human Papillomavirus (HPV). 14 September 2020. https://www.cdc.gov/cancer/hpv/basic_info/cancers.htm. Last accessed on 10 Aug 2021.

14. Public Health Agency of Canada. Human Papillomavirus (HPV). 11 October 2012 https://www.canada.ca/en/public-health/services/diseases/human-papillomavirus-hpv.html. Last accessed on 1 September 2021.

15. Canadian Cancer Society. Survival Statistics for Cervical Cancer. https://www.cancer.ca:443/en/cancer-information/cancer-type/cervical/prognosis-and-survival/survival-statistics/?region=on  Last accessed on 10 Aug 2021.

SOURCE Hologic, Inc.

Media Contact: Ana Laing, GCI Canada, 416.460.2338, [email protected]