Learning Objectives:

1. Demonstrate the global need for improved cervical cancer screening by reviewing current data supporting the transition to HPV primary screening as the standard of care.
2. Explain the varying risk associated with individual high-risk HPV genotypes and how this informs more precise triage and management strategies for CIN3+ detection.
3. Recognize the role of extended genotyping in optimizing triage, now reflected in the updated NCI/ASCCP Enduring Guidelines.*
4. Examine the clinical relevance of self-collection for HPV testing and how extended genotyping can enhance its effectiveness and integration into screening programs.
5. Review self-collection workflows and newly established CPT codes for HPV testing, enabling streamlined implementation in clinical practice.^†

Overview:

The American Society for Colposcopy and Cervical Pathology (ASCCP) has issued new guidelines reflecting the importance of extended genotyping in HPV testing to support optimized triage of HPV positive women. FDA approved HPV assays for primary screening that offer extended genotyping, like the BD Onclarity™ HPV Assay, the first FDA-approved HPV assay with both extended genotyping and self-collection in a healthcare setting^**, have great potential as cervical cancer screening continues to evolve toward a risk based screening paradigm, using HPV based primary screening, with optimized triage based on the presence of high-risk HPV and now HPV genotype.¹

The move to HPV testing has also facilitated even newer approaches to screening. The recently approved concept of self-collection can dramatically change cervical cancer screening practice². Because this sample type is for purely molecular analysis, the triage of such samples is most efficiently done on the same sample and currently extended genotyping is the best available method for this.  In addition, a new CPT code ^† has been issued to identify HPV tests that incorporate DNA testing and extended genotyping. As of May 2025, the BD Onclarity™ is the only FDA-approved HPV test that combines extended genotyping and FDA approval for self-collection in a healthcare setting.^**

This webinar, hosted by the CAP Foundation and presented by Dr. Mark Stoler, will cover HPV primary screening, extended genotyping, its importance in providing enhanced patient care, self-collection in a healthcare setting along with associated clinical workflow and how to code correctly ^† to capture the new reimbursement rate associated with HPV tests that incorporate extended genotyping.

^*ASCCP Guidelines: Journal of Lower Genital Tract Disease ():10.1097, January 10, 2025.

^† Health economic and reimbursement information provided by BD is gathered by third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. BD encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges and modifiers for services that are rendered. BD recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. BD does not promote the use of its products outside the FDA-cleared or FDA-market authorized labels.

**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.

1.Massad, L. Stewart MD1; Clarke, Megan A. PhD2; Perkins, Rebecca B. MD3, et al. Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines. Journal of Lower Genital Tract Disease 29(2):p 134-143, April 2025. | DOI: 10.1097/LGT.0000000000000865

2.Wentzensen, Nicolas MD, PhD1; Massad, L. Stewart MD2, Clarke, Megan A. PhD1, et al.  Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Self-Collected Vaginal Specimens for HPV Testing: Recommendations From the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Journal of Lower Genital Tract Disease 29(2):p 144-152, April 2025. | DOI: 10.1097/LGT.0000000000000885.