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The BD Onclarity™ HPV Assay has recently gained FDA approval for use with vaginal specimens self-collected in a healthcare setting when cervical specimens cannot otherwise be obtained, making it the first and only HPV test with extended genotyping to be FDA-approved for self-collection.1* The approval to allow women to collect their own vaginal samples in a healthcare setting — which could include non-traditional locations such as a retail pharmacy or mobile clinic — opens the door to a less invasive testing option and improves access to testing for individuals who face barriers to cervical cancer screening.


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Join the movement, increase access to cervical cancer screening

The cervical cancer screening landscape is rapidly changing. The use of vaginal samples, self-collected in a healthcare setting, marks a significant milestone in our joint efforts to improve accessibility and equity in healthcare.



1 in 4

eligible women are not up to date with cervical cancer screening in the United States. 3


Roughly 60%

of cervical cancer cases occur in unscreened or under-screened women, many of whom face barriers to accessing healthcare.4


may limit access

to cervical cancer screening for many women.5


Self-collection can improve cervical cancer screening access, especially in underserved populations. In the United States, 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.6,7 With vaginal self-collection as an option for cervical cancer screening, women are more inclined to participate in such care, allowing health care providers an alternative option to identify a high-risk HPV infection in more convenient care settings.5,7


The BD Onclarity™ HPV Assay empowers women to self-collect their own vaginal sample, opening up new possibilities in clinical practice, allowing you to offer a more patient-centered approach to cervical cancer screening.

Get in touch with BD to start empowering more women and increase access to cervical cancer screening

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Do not submit protected health information (PHI) or patient information (PII) through this form. If you do submit PHI or PII, your question may not be answered, as the information will be deleted to protect your privacy.


The innovative self-collection technology behind BD Onclarity™ HPV Assay

With the BD Onclarity™ HPV Assay, self-collection in a healthcare setting provides a less invasive, private alternative with comparable performance to cervical specimens, while offering all the benefits of an HPV test with extended genotyping supported by clinical guidelines.8-10

Increase screening participation by addressing many of the barriers that exist today, especially in underserved populations.5,7

Empower women by providing a less invasive and convenient sample collection option compared to traditional pelvic exam.

Self-collected vaginal samples offer comparable performance to clinician-collected cervical samples, when used with the BD Onclarity™ HPV Assay.2

Enjoy a convenient logistical chain from sample to testing with dry transport.2

Extended genotyping with BD Onclarity™ HPV Assay provides a greater and more refined level of risk stratification than pooled HPV-positive results to more precisely determine patient management.8-12

The BD Onclarity™ HPV Assay stands out as the first FDA-approved HPV test to be fully endorsed by the ASCCP extended genotyping Guidelines.8†

BD Onclarity™ HPV Assay

Why change TO BD Onclarity™ HPV Assay, now?


With BD Onclarity™ HPV Assay you can do more for your patients.

Offer more precise patient management

By using a test capable of individually identifying more high-risk HPV types you can more precisely determine a woman’s risk of cervical precancer and cancer compared to a test with a large, pooled "HPV Other" result – and ultimately offer your patients a more informed, personalized management strategy.9-12

Empower more women with self-collection

The BD Onclarity™ HPV Assay is the first FDA-approved HPV test with extended genotyping that empowers women to self-collect their own vaginal sample in a healthcare setting, providing a less invasive, private alternative with comparable performance to cervical specimens.2

In addition, the BD Onclarity™ HPV Assay is approved for HPV primary screening and co-testing, and is available out of BD SurePath™ Liquid-based Pap Test and Hologic ThinPrep® Pap Test, the two most common Pap vials used by laboratories in the United States.

Align with the most advanced guidelines

The BD Onclarity™  HPV Assay is the first FDA-approved HPV test with extended genotyping that meets all the ASCCP extended genotyping Guidelines.8
The ASCCP is currently preparing the next portion of Enduring Guidelines that will cover self-collection.

Be prepared for the future

As clinical research advances, new data, technologies and approaches will be incorporated into guidelines and clinical practice. The BD Onclarity™ HPV Assay provides flexibility to address evolving needs of clinicians and labs.

*Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.2
There are currently two FDA-approved HPV tests with extended genotyping with different configurations. The BD Onclarity™ HPV Assay was the only FDA-approved test with extended genotyping when the evidence review for the extended genotyping guidelines started, thus rendering the guidelines tailored specifically to the BD Onclarity™ HPV Assay.8

ThinPrep is a trademark of Hologic, Inc.

ASCCP, American Society for Colposcopy and Cervical Pathology; FDA, Food and Drug Administration; HPV, human papillomavirus.

1. BD Press Release. Women in U.S. Can Now Collect Their Own Sample for Cervical Cancer Screening. May 15, 2024.
2. BD Onclarity™ HPV Assay Package Insert [8089894].
3. National Cancer Institute Cancer Trends Progress Report. Cervical Cancer Screening. https://progressreport.cancer.gov/detection/cervical_cancer. Accessed May 2024.
4. Benard VB et al. Cancer Med. 2021;10(12):4127–37.
5. Zeno EE et al. PLoS One. 2022;17(10):e0274974.
6. Cohen CM et al. J Clin Oncol. 2023;41(5):1059–68.
7. MacDonald EJ, et al. Aust N Z J Obstet Gynaecol. 2021;61(1):135–41.
8. ASCCP. Public Comments on Draft Recommendations for Extended Genotyping. Accessed April 2024.
9. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
10. Stoler MH et al. Gynecol Oncol. 2023;174:68–75.
11. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1-264.e7.
12. Bonde JH et al. J Low Genit Tract Dis. 2021;25(1):27–37.