Women in U.S. Can Now Collect Their Own Sample for Cervical Cancer Screening

Rhea-AI Summary

On May 15, 2024, BD (Becton, Dickinson and Company) announced FDA approval for the use of self-collected vaginal specimens for HPV testing when cervical specimens cannot be obtained. This approval allows women to collect samples in various healthcare settings, including non-traditional locales like retail pharmacies and mobile clinics. The BD Onclarity™ HPV Assay, which doesn't require a traditional Pap smear, enhances access to cervical cancer screening, particularly for underserved populations. Around 25% of U.S. women do not receive regular cervical cancer screenings, with higher rates of cervical cancer among Black, Hispanic, and American Indian women. This initiative aims to increase screening acceptance and participation, offering a significant advancement in cervical cancer prevention.

Positive

• FDA approval for self-collected HPV testing enhances accessibility and convenience.
• BD Onclarity™ HPV Assay does not require a traditional Pap smear, reducing discomfort.
• Self-collection can improve screening uptake, especially in underserved populations.
• Self-collection offers a less invasive and more comfortable option for women.
• BD's partnership with NIH's Cervical Cancer 'Last Mile' Initiative aims to reduce screening disparities.
• BD Onclarity™ Assay reports six HPV strains individually for precise risk assessment.

Negative

• Potential risk of inaccurate self-collected samples impacting test results.
• Higher operational costs may arise from the need to support non-traditional testing locations.
• Initial skepticism from healthcare providers and patients regarding the efficacy of self-collected samples.

Insights

Medical Research Analyst

FDA approval of the BD Onclarity™ HPV Assay for self-collected vaginal specimens is a significant milestone in cervical cancer screening. The self-collection method, coupled with the ability to detect individual HPV strains, could vastly improve early detection and prevention efforts. Self-collection addresses key barriers such as geographic inaccessibility, lack of local clinicians and patient discomfort with traditional pelvic exams, enhancing screening accessibility, especially for underserved populations. This can potentially lead to higher participation rates in cervical cancer screening, especially among those historically less likely to be screened.

The BD Onclarity™ HPV Assay's ability to identify and track specific HPV strains is a noteworthy advancement. Typically, HPV tests report multiple strains together, which can obscure the understanding of an individual's risk profile. By isolating and monitoring specific strains, healthcare providers can better stratify patients' risk levels and tailor follow-up and treatments more precisely. This may reduce unnecessary treatments for low-risk individuals while ensuring high-risk cases receive timely intervention.

In the long term, this innovation could help decrease cervical cancer rates and mortality, especially in high-risk groups. However, the success of this screening method will depend on the effectiveness of public education campaigns and the robustness of healthcare infrastructure to support widespread implementation of self-collection methods.

Market Research Analyst

The FDA approval of BD's self-collection HPV test could significantly influence the market dynamics. By improving access to cervical cancer screening, BD may capture a larger share of the market, especially in regions with limited healthcare access. The convenience of self-collection can attract a wide demographic, including women who might avoid traditional screening due to discomfort or logistical barriers.

From an investment perspective, this approval positions BD favorably against competitors by offering a unique and advanced testing option. The potential increase in test adoption could translate to higher revenues and market growth for BD. Additionally, the company's involvement in the Cervical Cancer 'Last Mile' Initiative indicates a strong commitment to addressing healthcare disparities, which could enhance its reputation and stakeholder trust.

However, it's important to monitor the implementation of this screening method and any challenges that may arise, such as ensuring accurate self-collection and managing the logistics of sample transport and processing. Investors should also keep an eye on potential responses from competitors who may introduce similar or improved technologies.

FRANKLIN LAKES, N.J., May 15, 2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) approval for the use of self-collected vaginal specimens for human papillomavirus (HPV) testing when cervical specimens cannot otherwise be obtained. The approval allows women to self-collect vaginal specimens for HPV testing in a health care setting, which could include non-traditional locations such as a retail pharmacy or mobile clinic.

HPV is the cause of virtually all cervical cancer, and HPV testing is the preferred screening method by the American Cancer Society in the United States. 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 opens the door to a less invasive testing option, and it improves access to testing for individuals who face barriers to cervical cancer screening.

"Many patients are uncomfortable with the intimate nature of a pelvic exam," said Dr. Jeff Andrews, board-certified gynecologist and vice president of Global Medical Affairs for Diagnostic Solutions at BD. "Also, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The option to self-collect in a clinical setting can help women overcome some of these barriers."

Cervical Cancer is Preventable
Cervical cancer is preventable, and screening plays a crucial role in early detection and prevention. According to the American Cancer Society, approximately 50% of cervical cancer diagnoses are in never-screened people, and 10% of diagnoses occurs in under-screened individuals. In addition, 25% of women in the U.S. do not receive regular cervical cancer screening, according to the National Cancer Institute.

Various factors contribute to inadequate screening, including physical and geographic inaccessibility, financial insecurity (including lack of health insurance coverage), lack of awareness about the importance of screening, social or religious preferences, physical disability, medical conditions, or history of sexual, physical or psychological abuse that may make a pelvic examination for sample collection by a clinician traumatizing.

Self-Collection Improves Access
Self-collection can improve cervical cancer screening access, especially in underserved populations. In the U.S., Black, Hispanic and American Indian women have higher rates of cervical cancer than women of other racial groups, with Black women having the highest rate of death. With vaginal self-collection as an option for cervical cancer screening, women are more inclined to participate in such care — with never-screened women demonstrating a more than two-fold increase in acceptance and participation — allowing health care providers an alternative option to identify a high-risk HPV infection in more convenient care settings.^1 2

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), has been working with BD in a public-private partnership called the Cervical Cancer "Last Mile" Initiative to address disparities in cervical cancer screening. As part of this initiative, BD will be a participant in the Self-collection of HPV testing to Improve Cervical Cancer Prevention (SHIP) trial, which will begin enrolling this summer, to evaluate accuracy of self-collection for HPV testing both in health care and other settings, including at home. 

Some HPV Strains Carry a Higher Risk than Others
There are many strains (genotypes) of HPV viruses, with some strains posing a much higher risk for causing precancer and cancer than others. BD Onclarity™ is the first FDA-approved assay that reports six HPV strains individually, providing a more precise, accurate way to measure a women's risk for developing cervical precancer by showing results for an extended set of individual HPV strains and enabling those strains to be tracked over time. Most clinically validated tests report multiple strains in a single pooled result that prohibits monitoring of specific strains over time, which is an important determinant of cervical cancer risk in women who test positive for HPV.

"The integration of self-collection with testing for individualized strains of HPV represents a significant advancement in cervical cancer screening," said Dr. Shieva Ghofrany, a practicing OB-GYN and Fellow of the American Congress of Obstetricians and Gynecologists. "Self-collection provides greater access to testing and BD Onclarity™ allows health care providers to determine the specific HPV strains present in the samples and more precisely identify and treat individuals at high-risk and avoid unnecessary treatments for women at low risk."

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

¹ MacDonald EJ, Geller S, Sibanda N, et al. Reaching under–screened/never–screened indigenous peoples with human papilloma virus self–testing: A community–based cluster randomised controlled trial.
²  Australian and New Zealand Journal of Obstetrics and Gynaecology. 2020;61(1):135-141. doi:https://doi.org/10.1111/ajo.13285

View original content to download multimedia:https://www.prnewswire.com/news-releases/women-in-us-can-now-collect-their-own-sample-for-cervical-cancer-screening-302145620.html

SOURCE BD (Becton, Dickinson and Company)

FAQ

What is the significance of BD's FDA approval for self-collected HPV testing?

The approval allows women to self-collect vaginal specimens for HPV testing, improving access and convenience, particularly in underserved areas.

How does the BD Onclarity™ HPV Assay differ from traditional methods?

The BD Onclarity™ HPV Assay does not require a traditional Pap smear, reducing discomfort and improving accessibility for women.

Which populations benefit most from self-collected HPV testing?

Underserved populations, including Black, Hispanic, and American Indian women, benefit most due to higher rates of cervical cancer and lower screening participation.

What are the potential risks associated with self-collected HPV testing?

Potential risks include inaccurate self-collected samples, which could impact test results and the efficacy of the screening process.

How does BD Onclarity™ HPV Assay improve cervical cancer risk assessment?

The assay reports six HPV strains individually, allowing for precise monitoring of specific strains over time and better risk assessment.