Director Scientific Affairs Becton Dickinson and Company Cockeysville, Maryland, United States
Introduction: The BD Onclarity HPV Assay received additional approval from FDA in 2021 to report extended genotypes, focusing on the 9-valent vaccine types. We report on genotyping data with cytology and histology outcomes from up to 2 years of routine screening using a novel IRB-exempt study protocol. Methods: Data from patients undergoing routine screening or referred for abnormal cytology or HPV results were collected, de-identified and then linked to cytology and histology results. The data was then analyzed to investigate the contribution to disease of specific genotypes, stratified by age, cytology, and histology outcomes. Results: ~38,000 HPV tests resulted in 3,849 HPV positives and 255 CIN2/3 cases. We confirmed a 4-valent vaccine related reduction in HPV 16 infections (37% of all disease cases) and the growing importance of non-HPV16/18 types in disease, with HPV 52 and HPV 31 contributing to 14% and 12% of CIN2/3 cases, respectively. HPV+ age-stratification revealed that HPV 56_59_66 and HPV 51 channel positivity was highest in women < 30 and then decreased with age, whereas 9-valent type infections increased with age, peaking in women 30-39. Conclusion/Implications: Extended genotyping identifies patients with highest risk of disease (e.g., HPV 52 and HPV31) and helps to avoid unnecessary colposcopy in patients with reduced risk. 9-valent vaccine types tend to peak in incidence in middle-aged women whereas high-risk types with reduced risk were more common in younger women. These results are discussed in the context of optimal patient management and the anticipated changes in the ASCCP Management Guidelines that will include extended genotyping.
Disclosure(s):
Laurence M. Vaughan, PhD: Becton Dickinson and Company: Employee (Ongoing)
Molly Broache, MSN, RN, BSN, WHNP: Becton, Dickinson and Company (BD): Employee (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing)
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