With the extended genotyping guidelines now confirmed and the ASCCP App update underway, make sure that your clinic and laboratory has access to this new technology supported by the ASCCP.
The 2024 ASCCP Enduring Risk-Based Management Guidelines aim to integrate new technologies and approaches that improve cancer prevention for high-risk individuals and decrease unnecessary procedures in lower-risk individuals.1
Extended genotyping is defined as the identification of individual types or groups of types beyond just HPV 16, 18 and 45. The new 2024 guidelines include HPV genotyping beyond HPV 16/18, to include management recommendations for HPV 31, 45, 33/58, 52, 35/39/68, 51 and 59/56/66.1
BD Onclarity™ HPV Assay is the first FDA-approved assay with extended genotyping to be cited in guidelines for the clinical management of a positive HPV test result.1*
Extended genotyping provides a greater and more refined level of risk stratification than pooled HPV-positive results to more precisely determine patient management.1-3
HPV persistence (repeated detection of the same HPV type) is associated with a higher risk of cervical precancer compared to a single time point detection.1,4,5
Unnecessary procedures can be safely decreased in lower-risk individuals who test positive for HPV 56/59/66.1
The attribution of some HPV types to cancer differs somewhat across populations with different ancestry, emphasizing that extended genotyping supports health equity in a unique way.1,6,7
How and why are guidelines updated?
Since 2019, Cervical Cancer Screening and Management Guidelines support a proactive, preventative risk-based approach that allows for the early detection of cervical lesions before they progress. Guidelines are regularly updated to integrate new data and technologies to advance the way in which we screen for cervical cancer.8
Limited genotyping guidelines for HPV 16 and 18 were previously published in 2019 in the 2019 ASCCP Risk-based Management Guidelines. These guidelines were built upon data collected up to 2017, when HPV extended genotyping had not yet received FDA approval. At that time, the available HPV tests only had limited genotyping, meaning that they could only detect HPV 16 and HPV 18 individually (or HPV 18/45) and grouped the other 12 high-risk HPV types in a large, pooled "HPV Other" result.8
Since then, research has progressed, more clinical data has been collected, and, more importantly, HPV extended genotyping (a test that can identify individual types or groups of types beyond just HPV 16, 18 and 45) has now been on the market for several years.9
In 2024, after carefully analyzing the most recent clinical data, the ASCCP recognized that HPV extended genotyping results provide a greater and more refined level of risk stratification than limited genotyping2-5 and integrated the BD Onclarity™ HPV Assay into guidelines.1
This form is only intended for use by healthcare professionals seeking additional information about BD products and solutions. Patients seeking health and treatment information should contact their healthcare professional and can find additional resources from ACOG and the American Cancer Society.
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.
With BD Onclarity™ HPV Assay you can do more for your patients, without having to change your habits in cervical cancer screening.
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.2-5
Align with the most advanced guidelines
The BD Onclarity™ HPV Assay is the first FDA-approved HPV test with extended genotyping to be cited in the ASCCP Enduring Risk-Based Management Guidelines, which changes the landscape of cervical cancer screening in the United States.1
With the new ASCCP guidelines and app in place, more clinicians will seek to incorporate extended genotyping into clinical practice and more laboratories to offer extended genotyping.
Choose your preferred method
The BD Onclarity™ HPV Assay 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. In addition, BD Onclarity™ HPV Assay is approved for HPV primary screening, co-testing, and reflex testing for ASC-US results.9
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.
Extended genotyping with BD Onclarity™ HPV Assay refines patient risk stratification and advances the way in which we screen for cervical cancer.1-5
*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.1
†Cintec® PLUS Cytology test is the only FDA-approved dual stain test currently available and is only indicated for use in conjunction with a positive HPV result from a cobas® HPV test.
ThinPrep is a trademark of Hologic, Inc.
ASCCP, American Society for Colposcopy and Cervical Pathology; AGC, atypical glandular cells; ASC-H, atypical squamous cells of uncertain significance cannot exclude high grade squamous intraepithelial lesion; ASC-US, atypical squamous cells of uncertain significance ; DS, dual stain; FDA, Food and Drug Administration; HPV, human papillomavirus; HSIL, high grade squamous intraepithelial lesion; LSIL, low grade squamous intraepithelial lesion; NILM, negative for intraepithelial lesion or malignancy.
1. ASCCP. Public Comments on Draft Recommendations for Extended Genotyping. Accessed April 2024.
2. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
3. Stoler MH et al. Gynecol Oncol. 2023;174:68–75.
4. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1-264.e7.
5. Bonde JH et al. J Low Genit Tract Dis. 2021;25(1):27–37.
6. Risley C et al. Prev Med. 2021;153:106740.
7. Pinheiro M et al. Int J Cancer. 2020;147(10):2677–86.
8. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102–31.
9. BD Onclarity™ HPV Assay Package Insert [8089894]. 10. digene® HC2 High-Risk HPV DNA Test Package Insert.
11. Aptima™ HPV Assay Package Insert.
12. Cervista™ HPV HR Package Insert.
13. cobas® HPV for 4800 System Package Insert.
14. cobas® HPV for 6800/8800 System Package Insert.
15. Alinity m HR HPV AMP Kit Package Insert.
Learn more about our BD Women’s Health solutions
This form is only intended for use by healthcare professionals seeking additional information about BD products and solutions. Patients seeking health and treatment information should contact their healthcare professional and can find additional resources from ACOG and the American Cancer Society.
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.
