BD Aims to Save Lives by Empowering Women with Choice and Access to Cervical Cancer Screening Self-Collected At Home

Rhea-AI Summary

BD (NYSE: BDX) has submitted an FDA application for a groundbreaking at-home HPV testing solution that could revolutionize cervical cancer screening. The innovative system combines a user-friendly self-collection swab with advanced laboratory robotics through the BD COR™ System.

The technology detects more high-risk HPV strains than any other available test and features a convenient self-collection process that eliminates the need for in-office gynecological visits. According to a Harris Poll survey, 72% of U.S. women have delayed gynecology visits, while 81% desire more comfortable testing options. The BD Onclarity™ Assay has been included in ASCCP's Enduring Risk-Based Management Guidelines, and self-collection testing is currently under consideration in USPSTF draft recommendations.

Positive

• Technology detects more high-risk HPV strains than any other test on the market
• Automated BD COR™ System reduces manual laboratory work and improves efficiency
• Strong market potential supported by 74% of women indicating interest in at-home testing
• BD Onclarity™ Assay included in ASCCP's Enduring Risk-Based Management Guidelines

Negative

• Product still pending FDA approval
• May face competition from existing in-office testing methods

Insights

Medical Technology Analyst

BD's FDA submission for novel at-home HPV testing could expand screening access while leveraging their automation technology and comprehensive strain detection.

BD's FDA submission for a new at-home HPV testing solution represents a strategic expansion of their diagnostic portfolio into the high-growth home testing market. This innovation addresses a significant clinical need, as cervical cancer claims over 4,000 lives annually in the US despite being largely preventable through screening.

The technology offers three distinct competitive advantages: (1) a simplified self-collection swab stable enough for mail transport without liquids or complex devices; (2) compatibility with the BD COR™ System for fully automated laboratory processing; and (3) the BD Onclarity™ Assay's ability to detect more high-risk HPV strains than competing tests—critical as HPV strain prevalence shifts beyond types 16/18.

Market research supports demand, with 72% of surveyed women reporting delayed gynecological visits and 74% expressing interest in at-home self-collection options. The product aligns with evolving clinical guidelines, including recognition by the American Society for Colposcopy and Cervical Pathology and draft recommendations from the US Preventive Services Task Force.

This submission strategically positions BD at the intersection of two healthcare trends: increasing automation in clinical laboratories (allowing staff to focus on higher-value work) and expanding patient access through home-based testing options. If approved, this product could improve screening rates among underserved populations while generating new revenue streams in the women's health diagnostics segment.

New FDA Submission Includes Self-Collection Swab and High-Tech Laboratory Robotics that Report More High-Risk HPV Strains Than Any Other Test

FRANKLIN LAKES, N.J., July 31, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has submitted an application to the U.S. Food and Drug Administration for a new, at-home human papillomavirus (HPV) test that enables patients to self-collect a sample in the comfort of their own home using a swab the size of a Q-tip that simplifies processing at the lab and reports more high-risk strains of HPV than any other test on the market today.

"We envision a world where women are empowered with access and a choice for their HPV screening, whether it be in a routine visit at the doctor's office or the comfort and privacy of their own home via a self-collected sample," said Nikos Pavlidis, president of BD Diagnostic Solutions. "Cervical cancer and the loss of more than 4,000 women per year to this devastating disease is preventable, and we believe at-home testing is an important leap forward to our goal of eliminating this type of cancer."

When available, the new HPV test from BD will include a state-of-the-art self-collection swab technology that offers a safe, simple and non-invasive collection experience without the need for liquids or complex devices. The stability of the swab also allows for convenient mailing from home to the lab, removing logistical barriers and supporting broader participation in cervical cancer screening programs.

At the lab, the self-collected swab needs no manual sample preparation by clinical laboratory technologists, which allows them to focus on higher value work. The sample is simply placed into the BD COR™ System and the fully automated process uses sophisticated robotics to prepare, analyze and report results for each sample. Using an internal cellular control and minimizing manual touch and intervention ensures the integrity of the specimen from collection to delivery of dependable, high-quality results.

Importantly, the BD Onclarity™ Assay can also report more individual high-risk strains of HPV than any other test available today. This is a must-have attribute in today's testing paradigm, due to the shifting prevalence of high-risk genotypes beyond HPV 16/18.

In November 2024, a survey of more than 1,100 women in the U.S. conducted online by the Harris Poll found that 72% of women in the United States have delayed having a gynecology visit, with many highlighting the need for greater convenience, comfort and ease for this critical cervical cancer screening process. The study also found that 81% of women want more comfortable and less invasive HPV/cervical cancer testing options versus a pelvic exam, with 74% indicating interest in using a self-collection vaginal swab test at home in place of going to an office or clinic where a doctor uses a speculum to collect a sample from their cervix.

Earlier this year, the American Society for Colposcopy and Cervical Pathology (ASCCP) added the BD Onclarity™ Assay to its Enduring Risk-Based Management Guidelines, due to its ability to individually identify more high-risk types of HPV. Self-collection for HPV/cervical cancer screening is also among the draft recommendations by the U.S. Preventive Services Task Force (USPSTF), which helps guide health care providers in the U.S. about the effectiveness of specific preventive care services to improve the health of people nationwide.

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. 

Contacts:
Media:	Investors:
Troy Kirkpatrick	Adam Reiffe
VP, Public Relations	Sr. Director, Investor Relations
858.617.2361	201.847.6927
troy.kirkpatrick@bd.com	adam.reiffe@bd.com

 

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What is BD's new HPV test submission to the FDA?

BD has submitted an application for an at-home HPV testing solution that combines a self-collection swab with the BD COR™ System, capable of detecting more high-risk HPV strains than any other available test.

How does BD's new HPV self-collection system work?

The system uses a Q-tip sized swab for self-collection at home, which can be mailed to the lab. The sample is then processed automatically by the BD COR™ System without requiring manual preparation.

What are the advantages of BD's new HPV testing technology?

The technology offers non-invasive collection, detects more high-risk HPV strains than competitors, eliminates need for clinic visits, and features fully automated laboratory processing with the BD COR™ System.

What percentage of women are interested in BD's at-home HPV testing?

According to a Harris Poll survey, 74% of women indicated interest in using a self-collection vaginal swab test at home instead of going to a clinic for traditional cervical screening.

Has BD's Onclarity™ Assay received any professional recognition?

Yes, the BD Onclarity™ Assay has been added to the American Society for Colposcopy and Cervical Pathology's (ASCCP) Enduring Risk-Based Management Guidelines.