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Human papillomavirus (HPV) testing for cervical screening increases diagnosis of precancer and reduces the incidence of cervical cancer more than cytology alone. However, real‐world evidence from diverse practice settings is lacking for the United States (U.S.) to support clinician adoption of primary HPV screening. Using a population‐based registry, which captures all cervical cytology (with or without HPV testing) and all cervical biopsies, we conducted a real‐world evidence study of screening in women aged 30 to 64 years across the entire state of New Mexico. Negative cytology was used to distinguish cotests from reflex HPV tests. A total of 264 198 cervical screening tests (with exclusions based on clinical history) were recorded as the first screening test between 2014 and 2017. Diagnoses of cervical intraepithelial neoplasia grades 2 or 3 or greater (CIN2+, CIN3+) from 2014 to 2019 were the main outcomes. Of cytology‐negative screens, 165 595 (67.1%) were cotests and 4.8% of these led to biopsy within 2 years vs 3.2% in the cytology‐only group. Among cytology‐negative, HPV tested women, 347 of 398 (87.2%) CIN2+ cases were diagnosed in HPV‐positive women, as were 147 of 164 (89.6%) CIN3+ cases. Only 29/921 (3.2%) CIN3+ and 67/1964 (3.4%) CIN2+ cases were diagnosed in HPV‐negative, cytology‐positive women with biopsies. Under U.S. opportunistic screening, across a diversity of health care delivery practices, and in a population suffering multiple disparities, we show adding HPV testing to cytology substantially increased the yield of CIN2+ and CIN3+. CIN3+ was rarely diagnosed in HPV‐negative women with abnormal cytology, supporting U.S. primary HPV‐only screening. [ABSTRACT FROM AUTHOR]

The US Food and Drug Administration supports innovations to facilitate new indications for high-risk human papillomavirus testing. This report describes the retrospective testing of stored specimens and analysis of existing data to efficiently and cost-effectively support a new indication for the Onclarity human papillomavirus assay (Becton, Dickinson and Company, BD Life Sciences - Integrated Diagnostic Solutions, Sparks, MD). The performance of this index test was compared with that of a predicate test, the cobas human papillomavirus assay (Roche Diagnostics, Indianapolis, IN). Both human papillomavirus assays are based on real-time polymerase chain reaction platforms that detect the presence of 14 high-risk human papillomavirus genotypes. The predicate assay reports human papillomavirus types 16 and 18 as individual results and the other 12 human papillomavirus genotypes as 1 pooled result. The index assay reports 9 independent results (human papillomavirus types 16, 18, 31, 33/58, 35/39/68, 45, 51, 52, and 56/59/66). Both the index and predicate assays are approved by the Food and Drug Administration for cervical cancer screening, but at the time that this study was initiated, the index human papillomavirus assay was not approved for use with cervical specimens collected in PreservCyt (Hologic, Inc, San Diego, CA) liquid-based cytology media. The performance of the index human papillomavirus assay was compared with that of the predicate human papillomavirus assay for the detection of cervical intraepithelial neoplasia grades 2 or greater and 3 or greater (≥CIN2 or ≥CIN3) using PreservCyt liquid-based cytology specimens collected from women aged 21 to 65 years. In addition, the ability of the index test's extended genotyping to stratify ≥CIN2 and ≥CIN3 risks, using these specimens, was evaluated. The New Mexico HPV Pap Registry was used to select an age- and cytology-stratified random sample of 19,879 women undergoing opportunistic cervical screening and follow-up in routine clinical practice across New Mexico. A subset (n = 4820) of PreservCyt specimens was selected from 19,879 women for paired testing by the index and predicate human papillomavirus assays within age and cytology strata and included women with or without cervical biopsy follow-up. Point estimate differences and ratios were calculated for cervical disease detection and positivity rates, respectively, with 95% confidence intervals to determine statistical significance. The cumulative risk of ≥CIN2 or ≥CIN3, with up to 5-year follow-up, was estimated for the index assay using Kaplan-Meier methods. The 5-year cumulative ≥CIN3 detection rates were 5.6% for the index assay and 4.6% for the predicate assay (difference, 1.0%; 95% confidence interval, 0.5%–1.5%). The ≥CIN3 positivity rates within <1 year were 95.3% for the index assay and 94.5% for the predicate assay (ratio, 1.01; 95% confidence interval, 0.98–1.06). The ≥CIN3 cumulative positivity rates for the index and predicate assays were also similar at 5 years. Among cases of ≥CIN3, the positive agreement rates between the index and predicate assays for human papillomavirus types 16 and 18 were 100.0% (95% confidence interval, 95.0%–100.0%) and 90.9% (95% confidence interval, 62.3%–98.4%), respectively. Human papillomavirus type 16 carried the highest ≥CIN2 or ≥CIN3 risk, followed by human papillomavirus types 18/31/33/58/52/45 and human papillomavirus types 35/56/59/51/56/59/66. The index and predicate human papillomavirus assays demonstrated equivalent performance, and extended human papillomavirus genotyping, using the index assay, provided effective ≥CIN2 and ≥CIN3 risk stratification, supporting a new indication for use of the index assay with PreservCyt. [ABSTRACT FROM AUTHOR]

Human papillomavirus (HPV) testing for cervical screening has been shown to increase the yield of precancerous disease and reduce the incidence of cervical cancer more than cytology alone. Here we document the state-wide uptake of co-testing with HPV and cytology in women aged 30–64 years as recommended by national and international bodies. Registry-based study of all screening cytology and HPV tests in New Mexico from 2008 to 2019 among women aged 21–64 years, with a focus on cytology negative tests to distinguish co-testing from reflex HPV testing to triage equivocal or mildly abnormal cytology. A total of 1,704,055 cervical screening tests from 681,440 women aged 21–64 years in the state of New Mexico were identified. The proportion of screening tests which were co-tests rose from 5.6% in 2008 to 84.3% in 2019 among women aged 30–64 years with a marked change from the near exclusive use of the Hybrid Capture II HPV test, (a signal amplified test method) to the use of target amplified HPV tests. The largest increases were seen between 2013 and 2015, reflecting the introduction and adoption of new clinical guidelines. Increases in co-testing were also seen in younger women. Co-testing is now well established in women aged 30–64 years, but smaller increases have also been seen at younger ages, although this is not currently recommended. The impact of co-testing on cervical disease outcomes and number of colposcopies and biopsies in routine population settings remain important, especially in young women. • Cervical cancer screening by co-testing increased from 5.6% in 2008 to 84.3% in 2019 among women ages 30–64 years. • Smaller increases in co-test usage were observed in women of younger ages, although not currently recommended. • The median screening interval increased from 15 to 39 months as screening guideline recommendations were adopted. • The near exclusive use of the Hybrid Capture II HPV test has changed to the use of target amplified HPV tests. [ABSTRACT FROM AUTHOR]

Introduction: Digital breast tomosynthesis (DBT) may decrease recall rates (RRs) and improve positive predictive values (PPVs) and cancer detection rates (CDRs) versus full-field digital mammography (FFDM). The value of DBT has not been assessed in New Mexico's rural and minority population. Objectives of this study were to compare RRs, CDRs, and PPVs using FFDM+DBT versus FFDM in screening mammograms at the University of New Mexico between 2013 and 2016 and to qualitatively evaluate patient decision-making regarding DBT. Materials and Methods: RRs, CDRs, and PPVs with 95% confidence intervals and relative risk were calculated from 35,147 mammograms. The association between relative risk and mammography approach was tested using Pearson's chi-square test. Twenty women undergoing screening were interviewed for qualitative evaluation of decision-making. Results: From 2013 to 2016, RRs were 8.4% and 11.1% for FFDM+DBT and FFDM, respectively. The difference in RRs became more pronounced with time. No significant difference was observed in PPVs or CDRs. Qualitative interviews revealed that the majority had limited prior knowledge of DBT and relied on provider recommendations. Conclusion: In New Mexico women undergoing screening mammography, a 30% relative risk reduction in RRs was observed with FFDM+DBT. Qualitative interviews suggest that women are aware of and receptive to DBT, assuming adequate educational support. Clinical Trials.gov ID: NCT03979729. [ABSTRACT FROM AUTHOR]