BD Simplifies At-Home HPV Testing to Broaden Access to Cervical Cancer Screening Outside United States

Rhea-AI Summary

BD (NYSE: BDX) announced an IVDR-certified, dry self-collection swab and fully automated lab workflow for HPV testing outside the United States on Oct 22, 2025. The solution enables safe at-home sample collection without liquids, supports mailing to labs, and requires no manual sample preparation for clinical laboratory technologists when used with the BD COR™ System.

Key technical points:

• 30-day dry sample stability, including up to 5 days at 45°C and 4 freeze/thaw cycles
• Onboard Rehydration Technology to eliminate manual prep
• Barcode-driven unified workflow and internal cellular control for specimen integrity

The product is expected to be commercially available across IVDR-recognized markets in the coming months.

Positive

• IVDR certification for the new self-collection swab
• Fully automated processing using the BD COR System requiring no manual prep
• 30-day dry sample stability, including up to 5 days at 45°C and 4 freeze/thaw cycles
• Onboard Rehydration Technology eliminates manual sample preparation
• Unified barcode-driven workflow for clinician and self-collected samples

Negative

• None.

Insights

Medical devices commercialization expert

BD received IVDR certification for a dry, self-collection HPV swab and plans automated, commercial rollout outside the U.S.

BD introduces a dry, no-liquid self-collection swab for HPV that is IVDR-certified in Europe and recognized by other countries; the sample is stable for 30 days, tolerates up to 5 days at 45°C and 4 freeze/thaw cycles, and integrates with the BD COR™ System for fully automated lab processing using onboard rehydration and barcode-driven workflows. The combination reduces manual sample prep and aims to streamline lab throughput while broadening access to at-home cervical screening.

The clinical and commercial value rests on regulatory recognition, supply and lab adoption; the announcement notes commercial availability across IVDR-recognized markets in the coming months, which is the primary near-term milestone to confirm market entry. Watch for regulatory clearances in additional markets, initial commercial launch timing and uptake metrics from laboratories once the product ships.

FRANKLIN LAKES, N.J., Oct. 22, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a new self-collection solution for HPV testing in markets outside the United States. This new innovation simplifies at-home sample collection for patients and further automates lab processing using high-tech robotics with the BD COR™ System.

The new swab technology has been certified through the In Vitro Diagnostic Medical Device Regulation (IVDR) in Europe, which is also recognized by many other countries around the world. The new self-collection technology provides a safe, simple and non-invasive collection experience for patients without the need for liquids or complex devices. The stability of the swab also allows for convenient mailing from home to the lab, helping to remove logistical barriers and support broader participation in cervical cancer screening programs.

At the lab, the self-collected swab requires no manual sample preparation by clinical laboratory technologists, allowing them to focus on higher value tasks. Once the sample is placed into the BD COR™ System, a fully automated process uses sophisticated robotics to prepare, analyze and report results for each sample. The use of an internal cellular control, combined with minimal manual touch and intervention, helps ensure the integrity of the specimen from collection through delivery of dependable, high-quality results.

"This certification marks a meaningful advancement in our efforts to expand access to cervical cancer screening around the world," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "By enabling fully automated processing of self-collected samples, we're helping laboratories improve efficiency while making it easier for underscreened persons to participate in screening programs from the comfort of their homes."

Key features of the IVDR-certified workflow include:

• Onboard Rehydration Technology that eliminates manual sample prep
• Safe, dry self-collection with no liquids or chemicals
• Simple, user-friendly process for patients, with easy mailing
• 30-day dry sample stability, including up to 5 days at 45°C and 4 freeze/thaw cycles
• Unified, barcode-driven workflow for both clinician-taken and self-collected samples
• Proven performance of the Copan FLOQSwab®

The BD Onclarity™ HPV Self-Collection with Onboard Rehydration Fully Automated Solution is expected to become commercially available across IVDR-recognized markets in the coming months, supporting public health efforts to expand access to cervical cancer screening while improving laboratory efficiency.

To learn more visit https://eu.bd.com/cervical-screening-solutions/en/

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:
Fallon McLoughlin		Adam Reiffe
Director, Public Relations		Vice President, Investor Relations
201.258.0361		201.847.6927
fallon.mcloughlin@bd.com		Adam.Reiffe@bd.com

 

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What did BD (BDX) announce on October 22, 2025 about at-home HPV testing?

BD announced an IVDR-certified dry self-collection swab and a fully automated BD COR System workflow for HPV testing outside the United States.

How long is the BD HPV self-collection swab stable for mailing to labs?

The swab has 30-day dry stability, including up to 5 days at 45°C and tolerates 4 freeze/thaw cycles.

Will BD's solution require manual sample preparation in clinical labs (BDX)?

No — the Onboard Rehydration Technology plus BD COR System enables fully automated processing with no manual sample prep.

When will the BD Onclarity HPV Self-Collection solution be available in IVDR markets?

BD expects the solution to become commercially available across IVDR-recognized markets in the coming months.

How does BD's self-collection product help expand cervical cancer screening (BDX)?

By enabling safe, dry at-home collection and mail-in stability, it reduces logistical barriers and supports broader participation in screening programs.