Testing of Integrated Human Papillomavirus mRNA Decreases Colposcopy Referrals: Could a Change in Human Papillomavirus Detection Methodology Lead to More Cost-Effective Patient Care?

Sauter, Jennifer L.; Mount, Sharon L.; John, Timothy L. St.; Wojewoda, Christina; Bryant, Ronald; Leiman, Gladwyn

doi:10.1159/000358246

Cited by 20 publications

(21 citation statements)

References 9 publications

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“…Our data show that these assays have similar sensitivities for the detection of patients with ՆCIN2 lesions, but the specificities vary, ranging from 27.1% for HC2 to 42.0% for APTIMA HPV. This observation aligns with those of past reports, showing that the mRNA-based APTIMA HPV test yields good specificity and may decrease the number of referrals for colposcopy compared to DNA-based HR HPV assays (20). Importantly, when we compared the results of the cobas HPV-16 and -18 tests directly to a biopsy endpoint of ՆCIN2, the percent specificity was observed to be highest at 86.6%.…”

Section: Discussionsupporting

confidence: 90%

Comparative Evaluation of Three Commercial Systems for Detection of High-Risk Human Papillomavirus in Cervical and Vaginal ThinPrep PreservCyt Samples and Correlation with Biopsy Results

et al. 2014

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Genital human papillomavirus (HPV) is the etiologic agent of more than 99% of all cervical cancers worldwide, with 14 genotypes being considered oncogenic or "high risk" because of their association with severe dysplasia and cervical carcinoma. Among these 14 high-risk types, HPV-16 and -18 account for approximately 70% of cervical cancers. The aim of this study was to evaluate three FDA-approved HPV nucleic acid-based tests for the ability to predict high-grade cervical intraepithelial neoplasias (CIN2 or worse) in corresponding tissue biopsy specimens. Residual specimens (total n ‫؍‬ 793, cervical n ‫؍‬ 743, vaginal n ‫؍‬ 50) collected in ThinPrep PreservCyt medium with a cytologic result of >atypical squamous cells of undetermined significance were tested by the Hybrid Capture 2 (HC2) assay (Qiagen, Gaithersburg, MD), the cobas HPV test (Roche Diagnostics, Indianapolis, IN), and the APTIMA HPV assay (Hologic, San Diego, CA). Genotyping for HPV-16 and HPV-18 was simultaneously performed by the cobas HPV test. Results were compared to cervical or vaginal biopsy findings, when they were available (n ‫؍‬ 350). Among the 350 patients with corresponding biopsy results, 81 (23.1%) showed >CIN2 by histopathology. The >CIN2 detection sensitivity was 91.4% by the cobas and APTIMA assays and 97.5% by HC2 assay. The specificities of the cobas, APTIMA, and HC2 assays were 31.2, 42.0, and 27.1%, respectively. When considering only positive HPV-16 and/or HPV-18 genotype results, the cobas test showed a sensitivity and a specificity of 51.9 and 86.6%, respectively. While the HC2, cobas, and APTIMA assays showed similar sensitivities for the detection of >CIN2 lesions, the specificities of the three tests varied, with the greatest specificity (86.6%) observed when the HPV-16 and/or HPV-18 genotypes were detected. Infection with human papillomavirus (HPV) is extremely common, with an estimated 75 to 80% of sexually active adults acquiring the virus before the age of 50 (1). Exposure to HPV may yield a number of clinical outcomes, ranging from asymptomatic infection or benign warts to highly invasive cervical carcinoma. The pathogenesis of HPV is dependent on a number of factors, but it is now understood that certain genotypes of the virus are more closely associated with the development of severe disease, including cancer. HPV genotypes are commonly separated into two broad categories, (i) "low risk" (types 6, 11, 40, 42, 43, 44, 53, 54, 61, 72, 73, and 81) and (ii) "high risk" (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), based on the degree of correlation between infection and the development of cervical cancer. Among the 14 high-risk (HR) genotypes, HPV-16 and HPV-18 have been estimated to account for approximately 70% of cervical cancers (2).Because of the association of infection with HR HPV and the development of cervical cancer, the detection of HR genotypes with nucleic acid-based tests (HPV tests) is now considered an important component of cervical cancer screening guidelines (3-5). According ...

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Section: Discussionsupporting

confidence: 90%

Comparative Evaluation of Three Commercial Systems for Detection of High-Risk Human Papillomavirus in Cervical and Vaginal ThinPrep PreservCyt Samples and Correlation with Biopsy Results

et al. 2014

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“…Of note is that the Aptima HPV RNA test showed statistically significantly higher specificity for high-grade disease than the HC2 test (159). Subsequent clinical studies have likewise shown that detecting E6/E7 mRNA has similar sensitivity but significantly higher specificity than tests that detect HPV DNA (115,(158)(159)(160)(161)(162)(163)(164)(165)(166)(167)(168)(169).…”

Section: E6/e7 Mrna Pcr (Reverse Transcriptase Pcr)mentioning

confidence: 97%

“…Detection of overexpression of E6/E7 mRNA may be more directly associated with disease progression. Since referral for colposcopic examination is recommended for women who test positive for high-risk HPV and have ASC-US cytology results, the increased specificity of the E6/E7 mRNA tests has the potential to reduce the number of referrals (158). The only commercially available FDA-approved tests that detect E6/E7 mRNA are the Aptima HPV assay and the APTIMA HPV16 18/45 genotype assay (Hologic Gen-Probe, Inc., San Diego, CA), which were FDA approved in late 2012.…”

Section: E6/e7 Mrna Pcr (Reverse Transcriptase Pcr)mentioning

confidence: 99%

Human Papillomavirus Laboratory Testing: the Changing Paradigm

2016

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SUMMARYHigh-risk human papillomaviruses (HPVs) cause essentially all cervical cancers, most anal and oropharyngeal cancers, and some vaginal, vulvar, and penile cancers. Improved understanding of the pathogenesis of infection and the availability of newer tests are changing the approach to screening and diagnosis. Molecular tests to detect DNA from the most common high-risk HPVs are FDA approved for use in conjunction with cytology in cervical cancer screening programs. More-specific tests that detect RNA from high-risk HPV types are now also available. The use of molecular tests as the primary screening tests is being adopted in some areas. Genotyping to identify HPV16 and -18 has a recommended role in triaging patients for colposcopy who are high-risk HPV positive but have normal cytology. There are currently no recommended screening methods for anal, vulvar, vaginal, penile, or oropharyngeal HPV infections. HPV testing has limited utility in patients at high risk for anal cancer, but p16 immunohistochemistry is recommended to clarify lesions in tissue biopsy specimens that show moderate dysplasia or precancer mimics. HPV testing is recommended for oropharyngeal squamous cell tumors as a prognostic indicator. Ongoing research will help to improve the content of future guidelines for screening and diagnostic testing.

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“…Studies show that little expression of E6/E7 mRNA may be detected in transient infections, but in persistent infections, E6/E7 mRNA is overexpressed. Therefore, detection of upregulated expression of E6/E7 mRNA can be directly related to disease progression and may further reduce the number of colposcopy referrals .…”

Section: New Concepts and Technologies For Early Prevention And Treatmentioning

confidence: 99%

The precision prevention and therapy of HPV‐related cervical cancer: new concepts and clinical implications

2018

Cancer Medicine

252

140

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Cervical cancer is the third most common cancer in women worldwide, with concepts and knowledge about its prevention and treatment evolving rapidly. Human papillomavirus (HPV) has been identified as a major factor that leads to cervical cancer, although HPV infection alone cannot cause the disease. In fact, HPV‐driven cancer is a small probability event because most infections are transient and could be cleared spontaneously by host immune system. With persistent HPV infection, decades are required for progression to cervical cancer. Therefore, this long time window provides golden opportunity for clinical intervention, and the fundament here is to elucidate the carcinogenic pattern and applicable targets during HPV‐host interaction. In this review, we discuss the key factors that contribute to the persistence of HPV and cervical carcinogenesis, emerging new concepts and technologies for cancer interventions, and more urgently, how these concepts and technologies might lead to clinical precision medicine which could provide prediction, prevention, and early treatment for patients.

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Testing of Integrated Human Papillomavirus mRNA Decreases Colposcopy Referrals: Could a Change in Human Papillomavirus Detection Methodology Lead to More Cost-Effective Patient Care?

Cited by 20 publications

References 9 publications

Comparative Evaluation of Three Commercial Systems for Detection of High-Risk Human Papillomavirus in Cervical and Vaginal ThinPrep PreservCyt Samples and Correlation with Biopsy Results

Comparative Evaluation of Three Commercial Systems for Detection of High-Risk Human Papillomavirus in Cervical and Vaginal ThinPrep PreservCyt Samples and Correlation with Biopsy Results

Human Papillomavirus Laboratory Testing: the Changing Paradigm

The precision prevention and therapy of HPV‐related cervical cancer: new concepts and clinical implications

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