New Cervical Cancer Screening Guidelines from the American Cancer Society Risk Reversing Decades of Progress Made Against Cervical Cancer

If followed, guidelines would reduce ability of women and their doctors to choose widely adopted Pap-based testing strategies that have proven highly effective

MARLBOROUGH, Mass.–(BUSINESS WIRE)–#cervicalcancer–Hologic, Inc. (Nasdaq: HOLX) is disappointed that the American Cancer Society (ACS) has released guidelines for cervical cancer screening that significantly diverge from those of other leading medical and governmental institutions, including the American College of Obstetricians and Gynecologists (ACOG), the United States Preventive Services Task Force (USPSTF) and the Women’s Preventive Services Initiative (WPSI). By moving toward limiting options for women and overlooking critical data that supports time-tested screening strategies, the ACS now stands alone as an outlier among these organizations and institutions.

The rate of cervical cancer, which was a leading cause of death among women, has fallen by more than 70 percent since the Pap test was introduced over 50 years ago.^1,2 Previously, cervical cancer was the leading cause of cancer death in women, but now it is the fourteenth most frequent.^3,4 However, with the lengthening of screening intervals, cervical cancer rates have stagnated across the screening population and are increasing in some populations.⁵ So it is unclear why the ACS would want to put women’s health at risk by moving toward a future screening paradigm in which the preferred approach does not include the Pap test, and younger women – those under 25 years of age – would be excluded from screening altogether.

Importantly, the ACS guidelines are based on a proprietary model, the details of which have not been available to the scientific community for analysis, and conclusions based on this model are inherently contradictory. Specifically, the model predicts the identification of more treatable pre-cancer (CIN2 and CIN3) using the current standard of care over the newly recommended approach, yet counter-intuitively it also predicts increased rates of cancer incidence and death using the current standard of care.

In addition, real-world data demonstrate the superior performance of co-testing (the Pap test and HPV test together) as compared to either Pap or HPV testing alone. In particular, new clinical findings published earlier this month, based on the largest and most diverse longitudinal cervical cancer screening data to date, reaffirmed the use of co-testing as the most effective strategy for identifying women at risk of, or with, prevalent precancer and cancer. The analysis showed that co-testing identified 99.7 percent of pre-cancer cases and 94.1 percent of cervical cancer cases in women (<12 months of diagnosis).^6* This study also demonstrated that the use of HPV alone testing misses twice as much cervical cancer as co-testing, which is an astonishing increase and a significant step back in our efforts to reduce cervical cancer.

Current guidelines by other organizations^7,8,9 agree and maintain that the Pap test is a highly effective screening option for women ages 21 to 29 years old and recommend a combination of both the Pap test and HPV test (i.e., co-testing) for women ages 30 to 65 years old. The proposed ACS guidelines would diminish opportunities for women and their providers to make choices together as well as significantly reduce the options available to younger women, with potential unintended consequences to the care they receive. The evidence⁶ continues to show that standardized Pap and HPV testing together has been proven to detect the most cancers and save the most lives, which is why it is trusted and used by the majority of healthcare providers¹⁰ and laboratory professionals within the U.S.¹¹ Less than 1 percent of healthcare providers use HPV testing alone.¹⁰

For more than 30 years, Hologic has developed and brought to market new advances in cervical cancer screening, as well as supported critical cervical cancer research, education and collaboration efforts. As such, it is difficult to understand why decisions are being made that continue to erode women’s access to crucial preventive healthcare. We want all women to have access to early and accurate diagnostic testing that has been proven to save lives. Instead of simplifying, we fear the contradictory guidelines from the ACS will sow confusion among women and their healthcare providers and dangerously impact the incredible progress society has made in preventing cervical cancer.

We urge the ACS to live up to its mission of freeing the world from cancer by reconsidering its cervical cancer guidelines so women can continue to have access to the proven-effective tests they not only need but deserve.

*In the study, co-testing identified 99.7 percent of pre-cancer cases compared to 97.6 percent by the HPV test and 89.3 percent by the Pap test. Co-testing also identified 94.1 percent of cervical cancer cases compared to 77.5% by the HPV test and 85.1% by the Pap test.

About Pap+HPV Together

Pap+HPV Together (co-testing) provides the best protection currently available against cervical cancer for women ages 30-65.^12-13 Studies show up to 95% of cervical cancers can be detected by testing with Pap+HPV Together.^6,14 The Pap test helps healthcare providers detect the presence of abnormal cervical cells, and the HPV test identifies HPV infections that can lead to cervical disease.^15,16,17 Pap+HPV Together utilizes the same sample to screen for both cervical pre-cancer and cancer in women.

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.

Hologic Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

Source: Hologic, Inc.

¹ThinPrep 2000 Processor [instructions for use]. MAN-02624-001, Rev. 005. Marlborough, MA: Hologic, Inc.; 2017.

² National Cancer Institute. SEER Stat Fact Sheets: Cervix Uteri Cancer. http://seer.cancer.gov/statfacts/html/cervix.html. Accessed July 29, 2020.

³ Centers for Disease Control and Prevention. Cervical Cancer is Preventable. https://www.cdc.gov/vitalsigns/cervical-cancer/index.html. Updated November 5, 2014. Accessed July 29, 2020.

⁴ American Cancer Society. Cancer Facts and Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed July 29, 2020.

⁵ North American Association of Central Cancer Registries. Fast Stats https://faststats.naaccr.org/selections.php?#Output Accessed May 20, 2020.

⁶ Kaufman H., et al. Contributions of Liquid-Based (Papanicolaou) Cytology and Human Papillomavirus Testing in Cotesting for Detection of Cervical Cancer and Precancer in the United States. Am J Clin Pathol July 8, 2020.

⁷ US Preventive Services Task Force Final Update Summary: Cervical Cancer: Screening. http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cervical-cancer-screening. Accessed July 29, 2020

⁸ The American College of Obstetricians and Gynecologists. Practice Bulletin 168: Screening for cervical cancer. Obstet Gynecol. 2016;128(4):3111-30. doi:10.1097/ AOG.0000000000001708.

⁹ Women’s Preventive Services Guidelines. https://www.hrsa.gov/womens-guidelines-2016/index.html. Accessed July 29, 2020.

¹⁰ Albright DM, Rawlins S, Wu JS. Cervical cancer today: survey of screening behaviors and attitudes. Women’s Healthcare. 2020;8(3):41-46.

¹¹ Hologic, Inc. Data on File.

¹² Blatt AJ, et al. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015;123(5):282-288 [Study included ThinPrep®, SurePath®, Hybrid Capture® 2 assay].

¹³ The American College of Obstetricians and Gynecologists. Practice Bulletin 168: Screening for cervical cancer. Obstet Gynecol. 2016;128(4):3111-30. doi:10.1097/ AOG.0000000000001708.

¹⁴ Austin RM, et al. Enhanced Detection of Cervical Cancer and Precancer Through Use of Imaged Liquid-Based Cytology in Routine Cytology and HPV Co-testing. Am J Clin Pathol. 2018 Oct 1;150(5):385-392

¹⁵ ThinPrep 2000 Processor [instructions for use]. MAN-02624-001, Rev. 004. Marlborough, MA: Hologic, Inc.; 2017

¹⁶ Aptima HPV assay [package insert]. AW-12820-004-01, Rev. 004. San Diego, CA: Hologic, Inc.; 2020.

¹⁷ Aptima HPV Genotype 16 18/45 assay [package insert]. AW-12821-005-01, Rev. 005. San Diego, CA: Hologic, Inc.; 2020.

Contacts

Investor Contact:
Michael Watts

+1 858.410.8588

michael.watts@hologic.com

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+1 585.355.5978 (mobile)

jane.mazur@hologic.com