New ASCCP Guidelines Include More Precise Method of Cervical Cancer Screening
BD (NYSE: BDX) announced the inclusion of its BD Onclarity™ HPV Assay in the ASCCP Enduring Risk-Based Management Guidelines, marking a significant advancement in cervical cancer screening. The assay stands out for its ability to individually identify six of the 14 cancer-causing HPV types and group the remaining seven into three pooled results, offering more precise risk assessment than traditional tests that typically identify only two types.
The new guidelines support self-collection methods for cervical cancer screening, which is available with the BD Onclarity™ HPV assay in healthcare settings. This feature aims to improve access for those facing barriers to traditional screening methods. The guidelines acknowledge that extended genotyping provides better risk stratification and that repeated detection of the same HPV type indicates higher risk of cervical pre-cancer.
BD (NYSE: BDX) ha annunciato l'inclusione del suo BD Onclarity™ HPV Assay nelle Linee Guida ASCCP per la Gestione del Rischio Basato su Evidenze, segnando un progresso significativo nel controllo del cancro cervicale. Il test si distingue per la sua capacità di identificare singolarmente sei dei 14 tipi di HPV oncogeni e raggruppare i sette rimanenti in tre risultati aggregati, offrendo una valutazione del rischio più precisa rispetto ai test tradizionali che di solito identificano solo due tipi.
Le nuove linee guida supportano i metodi di auto-raccolta per lo screening del cancro cervicale, disponibili con il test BD Onclarity™ HPV negli ambienti sanitari. Questa caratteristica mira a migliorare l'accesso per coloro che affrontano barriere nei metodi di screening tradizionali. Le linee guida riconoscono che la genotipizzazione estesa fornisce una migliore stratificazione del rischio e che la ripetuta rilevazione dello stesso tipo di HPV indica un rischio più elevato di pre-cancro cervicale.
BD (NYSE: BDX) anunció la inclusión de su BD Onclarity™ HPV Assay en las Guías de Gestión Basadas en el Riesgo de ASCCP, marcando un avance significativo en la detección del cáncer cervical. El análisis se destaca por su capacidad para identificar individualmente seis de los 14 tipos de HPV que causan cáncer y agrupar los siete restantes en tres resultados combinados, ofreciendo una evaluación del riesgo más precisa que las pruebas tradicionales que generalmente solo identifican dos tipos.
Las nuevas guías apoyan métodos de auto-recolección para el tamizaje del cáncer cervical, los cuales están disponibles con el ensayo BD Onclarity™ HPV en los entornos de atención médica. Esta característica tiene como objetivo mejorar el acceso para aquellos que enfrentan barreras a los métodos de detección tradicionales. Las guías reconocen que la genotipificación extendida proporciona una mejor estratificación del riesgo y que la detección repetida del mismo tipo de HPV indica un mayor riesgo de pre-cáncer cervical.
BD (NYSE: BDX)는 BD Onclarity™ HPV Assay가 ASCCP 지속적인 위험 기반 관리 지침에 포함되었다고 발표하며, 자궁경부암 스크리닝에 있어 중요한 발전을 의미합니다. 이 검사는 14종의 암 유발 HPV 유형 중 6종을 개별적으로 식별할 수 있는 능력과 나머지 7종을 세 가지 pooled 결과로 그룹화하여 전통적인 검사보다 더 정확한 위험 평가를 제공합니다.
새로운 지침은 BD Onclarity™ HPV 검사를 통해 자궁경부암 스크리닝을 위한 자가 수집 방법을 지원합니다. 이 기능은 전통적인 스크리닝 방법에 장애를 겪는 사람들의 접근성을 향상시키는 것을 목표로 합니다. 지침은 확장 유전자 분석이 더 나은 위험 계층화를 제공하며, 동일한 HPV 유형의 반복 검출이 자궁경부 전암의 위험 증가를 나타낸다고 인정합니다.
BD (NYSE: BDX) a annoncé l'inclusion de son BD Onclarity™ HPV Assay dans les Lignes Directrices sur la Gestion des Risques Basés sur l'Épreuve de l'ASCCP, marquant une avancée significative dans le dépistage du cancer du col de l'utérus. Ce test se distingue par sa capacité à identifier individuellement six des 14 types de HPV responsables de cancer et à regrouper les sept autres en trois résultats groupés, offrant une évaluation du risque plus précise que les tests traditionnels qui n'identifient généralement que deux types.
Les nouvelles lignes directrices soutiennent les méthodes d'auto-collecte pour le dépistage du cancer du col de l'utérus, disponibles avec le test BD Onclarity™ HPV dans les milieux de soins de santé. Cette fonctionnalité vise à améliorer l'accès pour ceux qui rencontrent des obstacles aux méthodes de dépistage traditionnelles. Les lignes directrices reconnaissent que la génotypage élargi fournit une meilleure stratification des risques et que la détection répétée du même type de HPV indique un risque plus élevé de pré-cancer cervical.
BD (NYSE: BDX) hat die Aufnahme seines BD Onclarity™ HPV Assay in die ASCCP Richtlinien zur risikobasierten Nachverfolgung angekündigt, was einen bedeutenden Fortschritt im Bereich der Zervixkrebsfrüherkennung darstellt. Der Test zeichnet sich dadurch aus, dass er sechs der 14 krebsverursachenden HPV-Typen einzeln identifizieren und die verbleibenden sieben in drei Pool-Ergebnisse gruppieren kann, was eine genauere Risikobewertung als traditionelle Tests ermöglicht, die in der Regel nur zwei Typen identifizieren.
Die neuen Richtlinien unterstützen Selbstentnahme-Methoden für die Zervixkrebsfrüherkennung, die mit dem BD Onclarity™ HPV Assay in der Gesundheitsversorgung verfügbar sind. Diese Funktion soll den Zugang für diejenigen verbessern, die Barrieren zu traditionellen Screening-Methoden haben. Die Richtlinien erkennen an, dass eine erweiterte Genotypisierung eine bessere Risikostratifizierung liefert und dass die wiederholte Erkennung desselben HPV-Typs ein höheres Risiko für zervikale Präkanzerosen anzeigt.
- FDA approval obtained for self-collection testing in healthcare settings
- Enhanced market position with inclusion in ASCCP guidelines
- Superior technology offering identification of 6 individual HPV types versus competitors' 2 types
- Potential market expansion through improved accessibility with self-collection option
- None.
Insights
The inclusion of BD's Onclarity HPV Assay in ASCCP guidelines marks a significant advancement in cervical cancer screening technology. The assay's ability to identify six individual high-risk HPV types and group seven others into three pooled results represents superior diagnostic capabilities compared to traditional tests that typically identify only two types. This enhanced genotyping enables more precise risk stratification and personalized treatment planning.
The clinical value proposition is compelling - the ability to track specific HPV types across patient visits allows for better monitoring of viral persistence, which is a critical indicator of cancer risk. The approval for self-collection methods could substantially increase screening accessibility, potentially expanding BD's market reach in the
From a competitive standpoint, BD now holds a technological edge over current market players. The endorsement from ASCCP, coupled with the upcoming USPSTF recommendations supporting self-collection, positions BD favorably for increased market adoption and potential revenue growth in the diagnostics segment.
This regulatory recognition strengthens BD's market position in the women's health diagnostics sector. The expanded capabilities of the Onclarity assay create multiple revenue drivers:
- Increased test adoption due to ASCCP guideline inclusion
- Premium pricing potential from superior genotyping capabilities
- Market expansion through self-collection approval
The integration into the ASCCP mobile app, used by over 150,000 clinicians, provides a direct channel to healthcare providers, potentially accelerating market penetration. The timing aligns well with growing emphasis on preventive healthcare and personalized medicine, suggesting positive implications for BD's diagnostics segment growth trajectory.
BD Onclarity™ HPV assay adheres to new guidelines by identifying more individual types of HPV than any other test on the market
The new guidelines represent a significant step forward in cervical cancer prevention and management, offering a more precise and effective approach to screening for HPV, which in turn improves treatment design and supports efforts to eliminate cervical cancer.
Human papillomavirus (HPV) is the cause of virtually all cervical cancer, but there are many different types or strains (also called "genotypes") of HPV. The BD Onclarity™ HPV Assay employs extended genotyping, which allows for a more detailed analysis of the HPV types present in a person's body.
Traditional HPV tests typically individually identify no more than two different kinds of high-risk HPV. However, the BD Onclarity™ HPV Assay with extended genotyping can identify six of the 14 cancer-causing HPV types individually and group the remaining seven into three pooled results. These nine results allow for more precise risk assessment, persistence-tracking and personalized treatment plans to align with the new clinical recommendations.
"By identifying the specific HPV type and being able to track those types individually across a patient's visits, clinicians can more effectively manage high-risk cases and better guide follow-up for low-risk patients," said Dr. Jeff Andrews, a board-certified OB/GYN physician and vice president of medical affairs at BD. "This targeted approach can reduce potential reproductive harm and helps to ensure that women receive the most appropriate care for their situation."
Upcoming ASCCP guidelines also support the use of self-collection methods for cervical cancer screening, which is also offered in a health care setting with the BD Onclarity™ HPV assay. This makes it easier for women and people with a cervix to get screened, especially those who might face barriers to traditional screening methods, such as lack of time or discomfort with pelvic exams.
"With the recent FDA approval for self-collection in health care settings and now the inclusion of extended genotyping in the ASCCP guidelines, patients are poised to see significant improvement in both access to potentially life-saving screening and the precision of screening results," said Nikos Pavlidis, worldwide president of Diagnostic Solutions at BD.
The new guidelines integrate new technologies and approaches to improve cancer prevention for high-risk individuals and decrease unnecessary procedures in lower-risk individuals. The guidelines recognize that extended genotyping results provide additional risk stratification beyond a pooled high-risk result and that repeated detection of the same HPV type, even a lower-risk strain, is associated with a much higher risk of cervical pre-cancer compared to a single-time point detection.
ASCCP indicated that the guidelines will soon be used to update the popular ASCCP mobile application, downloaded for use by over 150,000 clinicians in the
Self-collection for HPV / cervical cancer screening is also among the recommendations recently released for public comment by the
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson
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SOURCE BD (Becton, Dickinson and Company)
FAQ
What are the key features of BD's Onclarity HPV Assay that differentiate it from competitors?
How does the inclusion in ASCCP guidelines benefit BDX's market position?
What is the significance of self-collection approval for BDX's HPV testing?
How does BDX's Onclarity HPV Assay align with new USPSTF recommendations?
