BDX Becton Dickinson and Company

BD Onclarity™ HPV assay adheres to new guidelines by identifying more individual types of HPV than any other test on the market

FRANKLIN LAKES, N.J., Jan. 13, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the BD Onclarity™ HPV Assay has officially been added to the American Society for Colposcopy and Cervical Pathology (ASCCP) Enduring Risk-Based Management Guidelines, due to its ability to individually identify more high-risk types of HPV.

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 U.S. to help inform their decision-making with an aim toward improving patient care.

Self-collection for HPV / cervical cancer screening is also among the recommendations recently released for public comment 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

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SOURCE BD (Becton, Dickinson and Company)