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Volume 47
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Integrating Molecular Diagnostics into Cervical Cancer Screening: A Workflow Using FFPE Tissue Samples

by
Serena Varesano
1,*,
Giulia Ciccarese
2,
Paola Parente
3,*,
Michele Paudice
4,5,
Katia Mazzocco
6,
Simone Ferrero
7,8 and
Valerio Gaetano Vellone
4,6
1
Hygiene Unit, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132 Genoa, Italy
2
Section of Dermatology, Department of Medical and Surgical Sciences, University of Foggia, Viale Pinto 1, 71122 Foggia, Italy
3
Unit of Pathology, Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, Viale Cappuccini 1, 71013 San Giovanni Rotondo, FG, Italy
4
Department of Integrated Surgical and Diagnostic Sciences (DISC), University of Genoa, Viale Benedetto XV 14, 16132 Genoa, Italy
5
Pathology University Unit, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132 Genoa, Italy
6
Pathology Unit, IRCCS Istituto Giannina Gaslini, Via G. Gaslini 5, 16147 Genoa, Italy
7
Obstetrics and Gynecology University Unit, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132 Genoa, Italy
8
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Largo Paolo Daneo 3, 16132 Genoa, Italy
*
Authors to whom correspondence should be addressed.
Curr. Issues Mol. Biol. 2025, 47(9), 679; https://doi.org/10.3390/cimb47090679 (registering DOI)
Submission received: 5 July 2025 / Revised: 21 August 2025 / Accepted: 22 August 2025 / Published: 24 August 2025
(This article belongs to the Special Issue Molecular Mechanism and Advances in Gynecological Pathology: From Bench to Bedside)
Review Reports Versions Notes

Abstract

Cervical cancer screening plays a crucial role in preventing invasive disease through early detection of high-grade lesions. However, traditional cytology and histology often fail to reliably differentiate between transient HPV infections and those likely to progress. This study investigates the feasibility of integrating molecular HPV testing into histopathological workflows using FFPE tissue samples to improve diagnostic precision. A retrospective analysis was conducted on 55 FFPE cervical specimens from patients undergoing colposcopy with biopsy or conization. The workflow included automated DNA extraction and real-time PCR-based HPV genotyping with the Seegene Anyplex II HPV28 assay. HPV DNA was detected in 56.4% of samples, with 21 genotypes, including multiple high-risk types. High viral loads correlated with high-grade lesions, supporting the clinical value of HPV quantification. Compared to histology, molecular analysis reduced potential overdiagnosis by confirming HPV absence in morphologically suspicious but HPV-negative lesions. Integrating viral load and genotyping improved risk stratification, optimizing colposcopy referrals and reducing unnecessary follow-ups. This study introduces a novel, fully automated molecular workflow applicable to FFPE samples, enhancing cervical cancer screening beyond traditional methods. Although based on a limited sample, the findings support the method’s potential for broader implementation and further validation in multicenter settings.
Keywords: cervical cancer; human papillomavirus; HPV screening; HPV genotyping; viral load assessment; molecular diagnostics; HPV from formalin-fixed paraffin-embedded blocks (FFPE); workflow; Italy cervical cancer; human papillomavirus; HPV screening; HPV genotyping; viral load assessment; molecular diagnostics; HPV from formalin-fixed paraffin-embedded blocks (FFPE); workflow; Italy

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MDPI and ACS Style

Varesano, S.; Ciccarese, G.; Parente, P.; Paudice, M.; Mazzocco, K.; Ferrero, S.; Vellone, V.G. Integrating Molecular Diagnostics into Cervical Cancer Screening: A Workflow Using FFPE Tissue Samples. Curr. Issues Mol. Biol. 2025, 47, 679. https://doi.org/10.3390/cimb47090679

AMA Style

Varesano S, Ciccarese G, Parente P, Paudice M, Mazzocco K, Ferrero S, Vellone VG. Integrating Molecular Diagnostics into Cervical Cancer Screening: A Workflow Using FFPE Tissue Samples. Current Issues in Molecular Biology. 2025; 47(9):679. https://doi.org/10.3390/cimb47090679

Chicago/Turabian Style

Varesano, Serena, Giulia Ciccarese, Paola Parente, Michele Paudice, Katia Mazzocco, Simone Ferrero, and Valerio Gaetano Vellone. 2025. "Integrating Molecular Diagnostics into Cervical Cancer Screening: A Workflow Using FFPE Tissue Samples" Current Issues in Molecular Biology 47, no. 9: 679. https://doi.org/10.3390/cimb47090679

APA Style

Varesano, S., Ciccarese, G., Parente, P., Paudice, M., Mazzocco, K., Ferrero, S., & Vellone, V. G. (2025). Integrating Molecular Diagnostics into Cervical Cancer Screening: A Workflow Using FFPE Tissue Samples. Current Issues in Molecular Biology, 47(9), 679. https://doi.org/10.3390/cimb47090679

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