WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche’s role in pioneering cervical cancer solutions
Roche announced that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline. Roche's CINtec PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test for triaging HPV-positive cervical cancer screening results. This follows the American Society for Colposcopy and Cervical Pathology (ASCCP)'s recent inclusion of dual-stain testing in its guidelines.
The CINtec PLUS Cytology test detects two biomarkers (p16 and Ki-67) within the same cell, indicating a higher risk of cervical disease. This can help reduce unnecessary colposcopy procedures and allow earlier intervention for high-risk cases. The test uses the same liquid sample as HPV or Pap cytology testing, eliminating the need for additional sample collection.
Roche's entire portfolio of HPV tests on various systems has also received WHO prequalification approval for both clinician-collected and self-collected samples.
Roche ha annunciato che l'Organizzazione Mondiale della Sanità (OMS) ha incluso il test citologico a doppia colorazione nelle sue linee guida per la prevenzione del cancro cervicale. Il test CINtec PLUS Cytology di Roche è l'unico test a doppia colorazione approvato dalla FDA e contrassegnato CE per la triage dei risultati degli screening cervicali positivi per HPV. Questo segue l'inclusione recente del test a doppia colorazione nelle linee guida della Società Americana per la Colposcopia e la Patologia Cervicale (ASCCP).
Il test CINtec PLUS Cytology rileva due biomarcatori (p16 e Ki-67) all'interno della stessa cellula, indicando un rischio maggiore di malattia cervicale. Questo può contribuire a ridurre le procedure di colposcopia non necessarie e consentire un'intervento più precoce nei casi ad alto rischio. Il test utilizza lo stesso campione liquido dei test per HPV o citologia Pap, eliminando la necessità di ulteriori raccolte di campioni.
L'intero portafoglio di test HPV di Roche su vari sistemi ha anche ricevuto l'approvazione di prequalifica da parte dell'OMS per campioni raccolti da clinici e campioni auto-raccolti.
Roche anunció que la Organización Mundial de la Salud (OMS) ha incluido la prueba de citología de doble tinción en su guía de prevención del cáncer cervical. La prueba CINtec PLUS Cytology de Roche es la única prueba de doble tinción aprobada por la FDA y marcada CE para la triage de resultados de cribado cervical positivos para HPV. Esto sigue la reciente inclusión de las pruebas de doble tinción en las guías de la Sociedad Americana de Colposcopia y Patología Cervical (ASCCP).
La prueba CINtec PLUS Cytology detecta dos biomarcadores (p16 y Ki-67) dentro de la misma célula, indicando un mayor riesgo de enfermedad cervical. Esto puede ayudar a reducir procedimientos de colposcopia innecesarios y facilitar una intervención más temprana en casos de alto riesgo. La prueba utiliza la misma muestra líquida que las pruebas de HPV o citología de Pap, eliminando la necesidad de recolección adicional de muestras.
Todo el portafolio de pruebas de HPV de Roche en varios sistemas también ha recibido la aprobación de precalificación de la OMS tanto para muestras recogidas por clínicos como para muestras autocolectadas.
로슈는 세계보건기구(WHO)가 자궁경부암 예방 가이드라인에 이중 염색 세포검사를 포함시켰다고 발표했습니다. 로슈의 CINtec PLUS 세포검사는 HPV 양성 자궁경부암 스크리닝 결과의 triage를 위한 유일한 FDA 승인 및 CE 인증 이중 염색 검사입니다. 이는 미국 자궁경부 병리학 및 콜포스코피 학회(ASCCP)의 최근 가이드라인에 이중 염색 검사가 포함된 것에 따른 것입니다.
CINtec PLUS 세포검사는 같은 세포 내에서 두 가지 바이오마커(p16 및 Ki-67)를 검출하여 자궁경부 질환의 위험이 높음을 나타냅니다. 이는 불필요한 콜포스코피 절차를 줄이고 고위험 사례에 대한 조기 개입을 가능하게 할 수 있습니다. 이 검사는 HPV 또는 파파니콜라우 세포 검사와 동일한 액체 샘플을 사용하여 추가 샘플 수집의 필요성을 없애줍니다.
로슈의 다양한 시스템에서 제공하는 HPV 테스트 전체 포트폴리오도 WHO의 사전 자격 승인을 받았으며, 임상 수집 샘플과 자가 수집 샘플 모두에 해당합니다.
Roche a annoncé que l'Organisation Mondiale de la Santé (OMS) a inclus le test de cytologie à double marquage dans ses recommandations de prévention du cancer du col de l'utérus. Le test CINtec PLUS Cytology de Roche est le seul test à double marquage approuvé par la FDA et portant le marquage CE pour le tri des résultats de dépistage du cancer du col de l'utérus positifs au HPV. Cela fait suite à l'inclusion récente des tests à double marquage dans les recommandations de la Société Américaine de Colposcopie et de Pathologie Cervicale (ASCCP).
Le test CINtec PLUS Cytology détecte deux biomarqueurs (p16 et Ki-67) au sein de la même cellule, indiquant un risque accru de maladie cervicale. Cela peut aider à réduire les procédures de colposcopie inutiles et permettre une intervention plus précoce pour les cas à haut risque. Le test utilise le même échantillon liquide que les tests HPV ou de cytologie Pap, éliminant ainsi le besoin de collectes d'échantillons supplémentaires.
Le portefeuille complet des tests HPV de Roche sur divers systèmes a également reçu l'approbation de préqualification de l'OMS pour les échantillons collectés par des cliniciens et les auto-échantillons.
Roche hat angekündigt, dass die Weltgesundheitsorganisation (WHO) den Doppel-Färbe-Zytologie-Test in ihre Leitlinien zur Prävention von Gebärmutterhalskrebs aufgenommen hat. Der CINtec PLUS Zytologietest von Roche ist der einzige von der FDA zugelassene und mit CE gekennzeichnete Doppel-Färbe-Test zur Triagierung von HPV-positiven Ergebnissen bei Gebärmutterhalskrebs-Screenings. Dies folgt der jüngsten Aufnahme von Doppel-Färbe-Tests in die Richtlinien der American Society for Colposcopy and Cervical Pathology (ASCCP).
Der CINtec PLUS Zytologietest erkennt zwei Biomarker (p16 und Ki-67) innerhalb derselben Zelle, was auf ein höheres Risiko für zervikale Erkrankungen hinweist. Dies kann helfen, unnötige Kolposkopie-Verfahren zu reduzieren und frühere Eingriffe bei Hochrisikofällen zu ermöglichen. Der Test verwendet dieselbe Flüssigkeitsprobe wie HPV- oder Pap-Zytologietests, wodurch die Notwendigkeit einer zusätzlichen Probenentnahme entfällt.
Das gesamte Portfolio von HPV-Tests von Roche auf verschiedenen Systemen hat ebenfalls die WHO-Vorabqualifizierung für sowohl von Fachleuten entnommene als auch selbst entnommene Proben erhalten.
- WHO endorsement of dual-stain cytology testing in cervical cancer prevention guidelines
- CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test for HPV-positive triage
- Potential reduction in unnecessary colposcopy procedures
- No need for additional sample collection as it uses the same liquid sample as HPV or Pap cytology testing
- WHO prequalification approval for Roche's entire portfolio of HPV tests on various systems
- None.
- Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results
- Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer.
- This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)’s recent inclusion of dual-stain testing in cervical cancer screening guidelines, as well as other WHO prequalifications of Roche’s cobas HPV test
Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.
The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy. However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures.
“Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology test to identify patients with an elevated risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “HPV infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk.”
The CINtec PLUS Cytology test can simultaneously detect when two biomarkers (p16 and Ki-67) are present within the same cell – a strong indicator that it is undergoing transformation and may turn cancerous. By identifying those individuals who are at higher risk of developing cervical disease, CINtec PLUS Cytology helps provide labs, clinicians and patients with important information to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing, eliminating the need for additional or repeat sample collection.
The revised WHO guidelines represent an important step forward in achieving the organisation’s three cervical cancer elimination goals3, and a catalyst for ensuring that
About the Roche Cervical Cancer Portfolio
HPV is the known cause of more than
The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain cytology product and CINtec Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions. The CINtec PLUS Cytology test can run on the BenchMark ULTRA IHC/ISH system. In countries accepting the CE mark, the CINtec PLUS Cytology test can be used to triage HPV-positive results.
The IMPACT trial, used to validate the clinical performance of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.5 This diversity was critical to accurately assess the performance of the cobas HPV test and dual stain cytology in patient populations with higher incident rates of HPV. Learn more now: http://diagnostics.roche.com.
Roche is piloting a disease management software called navify® Cervical Screening. It aims to support health systems to increase adherence to clinical guidelines, reduce under- and over-testing and optimise healthcare resources with an organised approach to screening.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] World Health Organization. WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: use of dual-stain cytology to triage women after a positive test for human papillomavirus (HPV). Brochure [Internet; updated 2024 June 4; cited 2024 July 3] Available from: https://www.who.int/publications/i/item/9789240091658
[2] American Society for Colposcopy and Cervical Pathology [Internet; updated 2024 March 11 ; cited August 14] Available from: https://www.asccp.org/enduring-guidelines-process
[3] World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. Article [Internet; updated 2020 November 17; cited 2023 Jan 3] Available from: https://www.who.int/publications/i/item/9789240014107
[4] National Cancer Institute. HPV and Cancer. Fact sheet [Internet; cited 2024 June 4] https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer#:~:text=Sexually%20transmitted%20HPV%20types%20fall,for%20most%20HPV%2Drelated%20cancers
[5] Safaeian M, Wright TC Jr, Stoler MH, Ranger-Moore J, Rehm S, Aslam S, Fang Q, Volkir P, Ridder R. The IMproving Primary Screening And Colposcopy Triage trial: human papillomavirus, cervical cytology, and histopathologic results from the baseline and 1-year follow-up phase. Am J Obstet Gynecol. 2021 Sep;225(3):278.e1-278.e16. doi: 10.1016/j.ajog.2021.03.047. Epub 2021 Apr 20. PMID: 33852886
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What is the significance of WHO endorsing dual-stain cytology testing for Roche (RHHBY)?
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