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First of Its Kind HPV Self-Collection Study Launched to Improve Cervical Cancer Screening in Underserved Communities

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A groundbreaking HPV self-collection screening pilot program has launched in Texas to improve cervical cancer screening in underserved communities. The study, conducted at Su Clinica in partnership with MD Anderson Cancer Center, utilizes the BD Onclarity™ HPV Assay (NYSE: BDX), recently FDA-approved for HPV self-collection screening. The initiative, supported by a $2.5 million CPRIT grant, aims to evaluate implementation effectiveness and develop scalable best practices for nationwide application. The program specifically targets communities facing healthcare barriers, offering bilingual options and financial support for uninsured patients.

È stato lanciato in Texas un programma pilota innovativo di screening per l'auto-raccolta dell'HPV per migliorare lo screening del cancro cervicale nelle comunità svantaggiate. Lo studio, condotto presso Su Clinica in collaborazione con il MD Anderson Cancer Center, utilizza il BD Onclarity™ HPV Assay (NYSE: BDX), recentemente approvato dalla FDA per lo screening dell'auto-raccolta dell'HPV. L'iniziativa, supportata da un finanziamento CPRIT di 2,5 milioni di dollari, mira a valutare l'efficacia dell'implementazione e a sviluppare pratiche ottimali scalabili da applicare a livello nazionale. Il programma si rivolge specificamente alle comunità che affrontano barriere sanitarie, offrendo opzioni bilingue e supporto finanziario per i pazienti non assicurati.

Se ha lanzado un programa piloto innovador de auto-recolección de pruebas de HPV en Texas para mejorar el cribado del cáncer de cuello uterino en comunidades desatendidas. El estudio, realizado en Su Clinica en asociación con el MD Anderson Cancer Center, utiliza el BD Onclarity™ HPV Assay (NYSE: BDX), recientemente aprobado por la FDA para la auto-recolección de pruebas de HPV. La iniciativa, respaldada por una subvención de CPRIT de 2.5 millones de dólares, tiene como objetivo evaluar la efectividad de la implementación y desarrollar mejores prácticas escalables para la aplicación a nivel nacional. El programa se centra específicamente en comunidades que enfrentan barreras de atención médica, ofreciendo opciones bilingües y apoyo financiero para pacientes no asegurados.

텍사스에서 HPV 자가 수집 검사 파일럿 프로그램이 시작되어 소외된 지역사회의 자궁경부암 검사를 개선하고 있습니다. 이 연구는 MD Anderson Cancer Center와 협력하여 Su Clinica에서 진행되며, 최근 FDA의 승인을 받은 BD Onclarity™ HPV Assay (NYSE: BDX)를 사용합니다. 이 이니셔티브는 250만 달러의 CPRIT 보조금으로 지원되며, 구현 효과성을 평가하고 전국적으로 적용 가능한 최선의 관행을 개발하는 것을 목표로 하고 있습니다. 이 프로그램은 의료 장벽에 직면한 커뮤니티를 구체적으로 겨냥하며, 이중 언어 옵션과 보험이 없는 환자를 위한 재정 지원을 제공합니다.

Un programme pilote révolutionnaire de dépistage par auto-collecte du HPV a été lancé au Texas pour améliorer le dépistage du cancer du col de l'utérus dans les communautés défavorisées. L'étude, réalisée à Su Clinica en partenariat avec le MD Anderson Cancer Center, utilise le BD Onclarity™ HPV Assay (NYSE: BDX), récemment approuvé par la FDA pour le dépistage par auto-collecte du HPV. L'initiative, soutenue par une subvention CPRIT de 2,5 millions de dollars, vise à évaluer l'efficacité de la mise en œuvre et à développer des meilleures pratiques évolutives pour une application à l'échelle nationale. Le programme cible spécifiquement les communautés confrontées à des obstacles à l'accès aux soins, offrant des options bilingues et un soutien financier pour les patients non assurés.

Ein bahnbrechendes HPV-Selbstentnahme-Screening-Pilotprogramm wurde in Texas gestartet, um die Vorsorgeuntersuchungen auf Gebärmutterhalskrebs in benachteiligten Gemeinschaften zu verbessern. Die Studie, die in Partnerschaft mit dem MD Anderson Cancer Center in Su Clinica durchgeführt wird, verwendet den BD Onclarity™ HPV Assay (NYSE: BDX), der kürzlich von der FDA für die Selbstentnahme von HPV-Tests genehmigt wurde. Die Initiative, die durch einen 2,5 Millionen Dollar CPRIT-Zuschuss unterstützt wird, zielt darauf ab, die Effektivität der Implementierung zu bewerten und skalierbare Best Practices für die landesweite Anwendung zu entwickeln. Das Programm richtet sich speziell an Gemeinschaften mit gesundheitlichen Barrieren und bietet zweisprachige Optionen sowie finanzielle Unterstützung für unterversicherte Patienten.

Positive
  • FDA approval for BD Onclarity™ HPV Assay for self-collection screening
  • $2.5 million grant funding secured for five-year program implementation
  • Expansion into underserved markets with significant growth potential
Negative
  • None.

Insights

This pilot program represents a significant advancement in cervical cancer screening accessibility. The FDA approval of BD's Onclarity HPV Assay for self-collection could be a game-changer for market penetration in underserved communities. The $2.5 million CPRIT grant provides substantial backing for a comprehensive five-year study that could establish BD as a leader in accessible HPV testing.

The study's focus on implementation in real-world healthcare settings is particularly valuable for validating the commercial viability of self-collection testing. Success here could lead to widespread adoption across other FQHCs nationwide, representing a significant market opportunity. The potential for developing scalable best practices could accelerate market expansion and strengthen BD's position in the HPV testing segment.

While the immediate revenue impact may be modest, this initiative positions BD strategically in the growing HPV testing market. The pilot program addresses a critical healthcare disparity while creating a potential new revenue stream through increased testing accessibility. Success could lead to broader adoption across the 1,400+ FQHCs nationwide, representing a substantial market opportunity.

The study's outcomes could influence healthcare policy and insurance coverage decisions, potentially making self-collection testing a standard screening option. This would significantly expand BD's addressable market beyond traditional clinical settings. The company's early-mover advantage in FDA-approved self-collection testing provides a competitive edge in this evolving market segment.

BROWNSVILLE, Texas, Nov. 20, 2024 /PRNewswire/ -- A first of its kind Human Papillomavirus (HPV) self-collection screening pilot program aimed at improving cervical cancer screening in underserved communities has officially launched in Texas. HPV is the cause of virtually all cervical cancers.

The study is being conducted at Su Clinica, a Federally Qualified Health Center (FQHC) with locations in Brownsville, Harlingen, Raymondville, and Santa Rosa, Texas, together with researchers at The University of Texas MD Anderson Cancer Center. This study will evaluate the implementation and effectiveness of self-collected HPV testing in a real-world health care setting. It also aims to identify any challenges and solutions for cervical cancer screening in communities with limited access to health care resources. This initiative will be using the BD Onclarity™ HPV Assay from BD (Becton, Dickinson and Company) (NYSE: BDX), which was approved earlier this year by the U.S. Food and Drug Administration (FDA) for HPV self-collection screening in health care settings.

"Not only can cervical cancer be prevented, with greater access to vaccines and screening, we have a real opportunity to eliminate this disease as a public health problem in our lifetimes," said Elena Marin, M.D., Chief Executive Officer at Su Clinica. "Women in our region are disproportionately affected by cervical cancer, both in terms of rates and mortality, so there is an urgent need to remove barriers to potentially life-saving screening, and self-collection is a pivotal solution. Having a test that is safe, private, and easy to use will go a long way towards increasing cancer screening rates for those who may be hesitant or unable to receive a traditional screening."

The BD Onclarity™ HPV Assay is FDA-approved for HPV primary testing without the need for a traditional Pap smear performed with a speculum. This new approval of self-collected samples in health care settings opens the door to a less invasive testing option, and it improves access to testing for individuals who face barriers to cervical cancer screening.

The findings from the pilot program will be used to develop potential best practices and implementation blueprints that can be scaled to other underserved communities, ultimately aimed at reducing cervical cancer rates and disparities nationwide. This initiative represents an important step towards achieving health equity for cervical cancer and improving health outcomes for all women.

Underserved communities often face significant barriers to accessing cervical cancer screening, including lack of insurance, limited health care resources, and cultural or language barriers. The program aims to overcome these challenges by providing bilingual self-collection options and financial support for uninsured patients.

The study is supported by a $2.5 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), to MD Anderson over a five-year period. Su Clinica is an FQHC that provides comprehensive health care services to the community and is implementing the program.

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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Mela Sera, APR
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Mela.Sera@bd.com  

Adam Reiffe

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Adam.Reiffe@bd.com 

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What is the FDA approval status of BD's (BDX) Onclarity HPV Assay for self-collection?

The BD Onclarity HPV Assay received FDA approval in 2024 for HPV self-collection screening in healthcare settings, eliminating the need for traditional Pap smears.

How much funding did the BDX HPV screening pilot program receive?

The program received a $2.5 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), distributed to MD Anderson over five years.

Where is BDX's HPV self-collection pilot program being implemented?

The program is being implemented at Su Clinica locations in Brownsville, Harlingen, Raymondville, and Santa Rosa, Texas, in partnership with MD Anderson Cancer Center.

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