Hologic Statement on USPSTF Draft Cervical Cancer Screening Guidelines
Hologic (HOLX) has responded to the United States Preventive Services Task Force (USPSTF) draft guidelines for cervical cancer screening. The company emphasizes the importance of combining Pap and HPV testing as the gold standard for cervical cancer detection. Cervical cancer mortality rates have decreased by 70% due to screening programs, though incidence rates have plateaued and disproportionately affect Black and Hispanic women.
Multiple studies show that screening women ages 30-65 with combined Pap and HPV testing identifies more cervical pre-cancer and cancer than single tests. The draft guidelines support three screening strategies, including Pap testing for women ages 21-29, and maintain flexibility for shared decision-making between healthcare providers and patients.
Hologic (HOLX) ha risposto alle linee guida preliminari del United States Preventive Services Task Force (USPSTF) per lo screening del cancro cervicale. L'azienda sottolinea l'importanza di combinare il test di Pap e il test per l'HPV come standard d'oro per la rilevazione del cancro cervicale. I tassi di mortalità per cancro cervicale sono diminuiti del 70% grazie ai programmi di screening, anche se i tassi di incidenza si sono stabilizzati e colpiscono in modo sproporzionato le donne nere e ispaniche.
Numerosi studi mostrano che lo screening delle donne di età compresa tra 30 e 65 anni con test combinati di Pap e HPV identifica più casi di pre-cancro cervicale e cancro rispetto ai test singoli. Le linee guida preliminari supportano tre strategie di screening, inclusa la valutazione con il test di Pap per le donne di età compresa tra 21 e 29 anni, e mantengono flessibilità per il processo decisionale condiviso tra fornitori di assistenza sanitaria e pazienti.
Hologic (HOLX) ha respondido a las pautas preliminares del United States Preventive Services Task Force (USPSTF) para el cribado del cáncer de cuello uterino. La empresa destaca la importancia de combinar las pruebas de Papanicolaou y HPV como el estándar de oro para la detección del cáncer de cuello uterino. Las tasas de mortalidad por cáncer cervical han disminuido en un 70% debido a los programas de cribado, aunque las tasas de incidencia se han estabilizado y afectan de manera desproporcionada a las mujeres afroamericanas e hispanas.
Múltiples estudios muestran que cribar a mujeres de 30 a 65 años con pruebas combinadas de Papanicolaou y HPV identifica más pre-cáncer y cáncer cervical que las pruebas individuales. Las pautas preliminares apoyan tres estrategias de cribado, incluyendo pruebas de Papanicolaou para mujeres de 21 a 29 años, y mantienen flexibilidad para la toma de decisiones compartida entre proveedores de atención médica y pacientes.
홀로직 (HOLX)는 미국 예방 서비스 태스크포스(USPSTF)의 자궁경부암 선별에 대한 초안 지침에 응답했습니다. 이 회사는 자궁경부암 검출을 위한 골드 스탠다드로서 파파니콜레오 검사와 HPV 검사를 결합하는 것의 중요성을 강조하고 있습니다. 자궁경부암으로 인한 사망률이 70% 감소했습니다는 선별검사 프로그램 덕분이며, 비율이 정체되고 있고 흑인과 히스패닉 여성에게 불균형적으로 영향을 미치고 있습니다.
여러 연구에서는 30세에서 65세 사이의 여성에게 파파니콜레오 검사와 HPV 검사를 결합하여 선별을 할 경우 단일 검사보다 더 많은 자궁경부 전암과 암을 식별할 수 있음을 보여줍니다. 초안 지침은 21세에서 29세의 여성에 대한 파파니콜레오 검사와 함께 세 가지 선별 전략을 지원하며, 의료 제공자와 환자 간의 공동 결정 유형에 대한 유연성을 유지합니다.
Hologic (HOLX) a répondu aux directives préliminaires du United States Preventive Services Task Force (USPSTF) concernant le dépistage du cancer du col de l'utérus. La société souligne l'importance de la combinaison des tests de Pap et du test HPV comme norme d'or pour la détection du cancer du col de l'utérus. Les taux de mortalité dus au cancer du col de l'utérus ont diminué de 70% grâce aux programmes de dépistage, bien que les taux d'incidence se soient stabilisés et touchent de manière disproportionnée les femmes noires et hispaniques.
De nombreuses études montrent que le dépistage des femmes âgées de 30 à 65 ans par des tests combinés de Pap et de HPV identifie plus de cas de pré-cancer et de cancer du col de l'utérus que les tests simples. Les directives préliminaires soutiennent trois stratégies de dépistage, y compris le test de Pap pour les femmes âgées de 21 à 29 ans, et maintiennent la flexibilité pour la prise de décision partagée entre les prestataires de soins de santé et les patients.
Hologic (HOLX) hat auf die vorläufigen Richtlinien der US-amerikanischen Preventive Services Task Force (USPSTF) zur Früherkennung von Gebärmutterhalskrebs reagiert. Das Unternehmen betont die Bedeutung der Kombination von Pap-Test und HPV-Test als den Goldstandard für die Erkennung von Gebärmutterhalskrebs. Die Sterberate bei Gebärmutterhalskrebs ist um 70% gesenkt worden dank der Screening-Programme, obwohl die Inzidenzraten stagniert sind und besonders afroamerikanische und hispanische Frauen unverhältnismäßig betroffen sind.
Mehrere Studien zeigen, dass das Screening von Frauen im Alter von 30 bis 65 Jahren mit kombinierter Pap- und HPV-Testung mehr Fälle von Gebärmutterhalsvorstufen und -krebs identifiziert als Einzeltests. Die vorläufigen Richtlinien unterstützen drei Screening-Strategien, einschließlich des Pap-Tests für Frauen im Alter von 21 bis 29 Jahren, und gewährleisten Flexibilität für die gemeinsame Entscheidungsfindung zwischen Gesundheitsdienstleistern und Patienten.
- Studies confirm combined Pap and HPV testing superiority in detecting cervical cancer
- USPSTF draft guidelines support company's testing approach
- 70% reduction in cervical cancer mortality demonstrates screening effectiveness
- Cervical cancer incidence rates have stopped declining
- Persistent disparities in cancer rates among Black and Hispanic women
Insights
The USPSTF draft guidelines' endorsement of combined Pap and HPV testing represents a significant validation of current screening practices but has immediate business impact for Hologic. While the company's ThinPrep Pap test and Aptima HPV assay are market leaders, these guidelines primarily reinforce existing protocols rather than expanding the screening market.
The maintenance of multiple screening options, including co-testing, helps protect Hologic's current market position. Their diagnostic solutions segment, which includes cervical cancer screening products, generates substantial recurring revenue. However, the draft nature of these guidelines and lack of major changes to screening recommendations means minimal near-term effect on Hologic's financial performance or stock value.
“Today’s recommendations are an important acknowledgement of the role of Pap testing combined with HPV testing, which is the gold standard of care and the most effective method of identifying cervical cancer,” said Jennifer Schneiders, PhD, President, Diagnostic Solutions at Hologic. “Eliminating cervical cancer is within our reach and history has shown us that safeguarding the most comprehensive screening available is critical to that effort.”
Once the leading cause of cancer death in women, cervical cancer mortality rates have plummeted by
Multiple studies and other research representative of real-world screening practices in the US demonstrate that screening women ages 30-65 with the Pap test combined with HPV test identifies more cervical pre-cancer and cancer than either test used alone.5-8 The draft recommendations reinforce the value of all three cervical cancer screening strategies for women including Pap testing for women ages 21-29 years old.9 The draft recommendations also continue to allow for shared decision-making between healthcare providers and patients and help ensure that women can continue to access the preventive care they need and deserve.
Hologic is committed to working with USPSTF and others within the cervical cancer community in support of final screening guidelines that preserve all screening options, improving our ability to combat this preventable cancer and save more women’s lives.
About Hologic
Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnosis and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X (Twitter), Instagram and YouTube.
SOURCE: Hologic, Inc.
References
- American Cancer Society. Cancer Statistics Center. https://cancerstatisticscenter.cancer.org/?_ga=2.150839477.2044751383.1547156654-294386523.1544563210#!/. Accessed December 4, 2024.
- Surveillance, Epidemiology, and End Results (SEER) Program. SEER*Stat Database: Incidence - SEER Research Data, 8 Registries, Nov 2023 Sub (1975-2021). Accessed December 4, 2024. https://seer.cancer.gov/statfacts/html/cervix.html
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Beavis AL, Gravitt PE. Hysterectomy-corrected cervical cancer mortality rates reveal a larger racial disparity in
the United States . Cancer. 2017;123(6):1044-1050. - Office of Minority Health, US Department of Health and Human Services. Cancer and Hispanic Americans. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=61. Accessed December 4, 2024.
- 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;150(5):385-392. doi: 10.1093/ajcp/aqy114
- 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. doi:10.1002/ cncy.21544
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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. 2020:XX:0-0 DOI: 10.1093/AJCP/AQAA074 - Zhou H, et al. Clinical performance of the Food and Drug Administration-Approved high-risk HPV test for the detection of high-grade cervicovaginal lesions. Cancer Cytopathol. 2016 May;124(5):317-23. doi: 10.1002/cncy.21687.
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U.S. Preventive Services Task Force. Draft Recommendation Statement. Cervical Cancer Screening. December 10, 2024. https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/cervical-cancer-screening-adults-adolescents
View source version on businesswire.com: https://www.businesswire.com/news/home/20241210733407/en/
Investor Contact
Ryan Simon
Vice President, Investor Relations
+1 858.410.8514
ryan.simon@hologic.com
Media Contact
Bridget Perry
Senior Director, Corporate Communications
+1 508.263.8654
bridget.perry@hologic.com
Source: Hologic, Inc.
FAQ
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