Clinical Validation

Bruno, M.T.; Bonanno, G.; Sgalambro, F.; Cavallaro, A.; Boemi, S. Overexpression of E6/E7 mRNA HPV Is a Prognostic Biomarker for Residual Disease Progression in Women Undergoing LEEP for Cervical Intraepithelial Neoplasia 3. Cancers 2023, 15, 4203. https://doi.org/10.3390/cancers15174203

Sørbye SW, Falang BM, Antonsen M. Distribution of HPV Types in Tumor Tissue from Non-Vaccinated Women with Cervical Cancer in Norway. Journal of Molecular Pathology. 2023; 4(3):166-177. https://doi.org/10.3390/jmp403001

Rad A, Sørbye SW, Tiwari S, Løchen M-L, Skjeldestad FE. Risk of Intraepithelial Neoplasia Grade 3 or Worse (CIN3+) among Women Examined by a 5-Type HPV mRNA Test during 2003 and 2004, Followed through 2015. Cancers. 2023; 15(12):3106. https://doi.org/10.3390/cancers15123106

Sørbye SW, Falang BM, Antonsen M. Performance of a 7-Type HPV mRNA Test in Triage of HPV DNA Primary Screen Positive Women Compared to Liquid-Based Cytology. Journal of Molecular Pathology. 2023; 4(2):69-80

Rad, A.; Sørbye, S.W.; Brenn, T.; Tiwari, S.; Løchen, M.-L.; Skjeldestad, F.E. 13-Type HPV DNA Test versus 5-Type HPV mRNA Test in Triage of Women Aged 25–33 Years with Minor Cytological Abnormalities–6 Years of Follow-Up. Int. J. Environ. Res. Public Health 2023, 20, 4119.

Khalid Al-Shibli, Hiba Abdul Latif Mohammed, Ramona Maurseth, Mikkel Fostervold, Sebastian Werner, Sveinung Wergeland Sørbye. “Impact of HPV mRNA types 16, 18, 45 detection on the risk of CIN3+ in young women with normal cervical cytology” PLOS ONE, 22nd Nov 2022.

Fausto Carcea, Eleftherios Vavoulidis, Stamatios Petousis, Panagiotis Papandreou, Chrysoula Margioula Siarkou, Maria Nasioutziki, Alexios Papanikolaou, Konstantinos Dinas, Angelos Daniilidis. “Diagnostic performance of HPV E6/E7 mRNA testing towards HPV-DNA testing and p16/Ki67 immunostaining as a biomarker of high-risk HPV recurrence in Greek women surgically treated for their cervical lesions.” J Obstet Gynaecol Res, 9th Aug 2021.

Aranda Flores, C.E., Gomez Gutierrez, G., Ortiz Leon, J.M. et al. Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests. BMC Infect Dis 21, 504 (2021).

Gry St-Martin, Lise Holst Thamsborg, Berit Andersen, Jette Christensen, Dorthe Ejersbo, Kirsten Jochumsen, Tonje Johansen, Lise Grupe Larsen, Marianne Waldstrøm & Elsebeth Lynge, et al. “Management of low-grade cervical cytology in young women. Cohort study from Denmark.” Acta Oncologica 8 Oct 2020.

Derbie, Awoke, et al. “HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review.” Infectious Agents and Cancer, vol. 15, no. 1, 2020, p. NA. Gale Academic OneFile, Accessed 28 Apr. 2020.

Westre B, Giske A, Guttormsen H, Sørbye SW, Skjeldestad FE.Quality control of cervical cytology using a 3-type HPV mRNA test increases screening program sensitivity of cervical intraepithelial neoplasia grade 2+ in young Norwegian women—A cohort study. PLoS One. 2019 Nov 5;14(11):e0221546.

Reinholdt K, Juul KE, Dehlendorff C, Munk C, Kjaer SK, Thomsen LT. Triage of low-grade squamous intraepithelial lesions using human papillomavirus messenger ribonucleic acid tests-A prospective population-based register study. Acta Obstet Gynecol Scand. 2019 Sep 28.

Baasland I, Romundstad PR, Eide ML, Jonassen CM. Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population. PLOS ONE. 2019 Jan 23;14(1):e0210997.

Rad A, Sørbye SW, Dreyer G, Hovland S, Falang BM, Louw M, Skjeldestad FE. HPV types in cervical cancer tissue in South Africa: A head-to-head comparison by mRNA and DNA tests Medicine: 2017 Nov, Vol 96(47) p e8752.

Sørbye SW, Fismen S, Gutteberg TJ, Mortensen ES, Skjeldestad FE. Primary cervical cancer screening with an HPV mRNA test: a prospective cohort study. BMJ Open. 2016 Aug 11;6(8):e011981.

Westre B, Giske A, Guttormsen H, Sørbye SW, Skjeldestad FE. 5-type HPV mRNA versus 14-type HPV DNA test: test performance, over-diagnosis and overtreatment in triage of women with minor cervical lesions. BMC Clin Pathol. 2016 Jun 7;16:9.

Sørbye SW, Fismen S, Gutteberg TJ, Mortensen ES, Skjeldestad FE. HPV mRNA Is More Specific than HPV DNA in Triage of Women with Minor Cervical Lesions. Lo AWI, ed. PLoS ONE 2014;9(11):e112934.

Frega A, Sesti F, Lombardi D, Votano S, Sopracordevole F, Catalano A, Milazzo GN, Lombardo R, Assorgi C, Olivola S, Chiusuri C, Ricciardi E, French D, Moscarini M. Assessment of HPV-mRNA test to predict recurrent disease in patients previously treated for CIN 2/3. J Clin Virol. 2014 May;60(1):39-43. Epub 2014 Feb 2.

Nygård M, Røysland K, Campbell S, Dillner J. Comparative effectiveness study on human papillomavirus detection methods used in the cervical cancer screening programme. BMJ Open 2014;4(1):e003460.

Verdoodt, F., Szarewski, A., Halfon, P., Cuschieri, K. and Arbyn, M. (2013), Triage of women with minor abnormal cervical cytology: Meta-analysis of the accuracy of an assay targeting messenger ribonucleic acid of 5 high-risk human papillomavirus types. Cancer Cytopathology, 121: 675–687.

Cuschieri K, Hardie A, Hovland S, Hoaas B, Karlsen F, Cubie H. Comparison of the sensitivities of three commercial assays for detection of the high risk HPV types 16, 18 and 45. J Virol Methods. 2013 Oct;193(1):147-50. Epub 2013 May 30.

Giorgi Rossi P, Benevolo M, Vocaturo A, et al. Prognostic Value of HPV E6/E7 mRNA Assay in Women with Negative Colposcopy or CIN1 Histology Result: A Follow-Up Study. Mulvenna J, ed. PLoS ONE 2013;8(2):e57600.

Mesher D, Szarewski A, Cadman L, Austin J, Ashdown-Barr L, Ho L, Terry G, Young M, Stoler M, Bergeron C, McCarthy J, Wright C, Liddle S6, Soutter WP, Lyons D, Cuzick J. Comparison of human papillomavirus testing strategies for triage of women referred with low-grade cytological abnormalities. Eur J Cancer. 2013 Jun;49(9):2179-86.

Cuzick J, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Ho L, Terry G, Liddle S, Wright C, Lyons D, Szarewski A. Comparing the performance of six human papillomavirus tests in a screening population. British Journal of Cancer 2013;108(4):908-913.

Alaghehbandan R, Fontaine D, Bentley J, Escott N, Ghatage P, Lear A, Coutlee F, Ratnam S. Performance of ProEx C and PreTect HPV-Proofer E6/E7 mRNA tests in comparison with the hybrid capture 2 HPV DNA test for triaging ASCUS and LSIL cytology. Diagn Cytopathol. 2013 Sep;41(9):767-75. Epub 2013 Jan 22.

Broccolo F, Fusetti L, Rosini S, Caraceni D, Zappacosta R, Ciccocioppo L, Matteoli B, Halfon P, Malnati MS, Ceccherini-Nelli L. Comparison of oncogenic HPV type-specific viral DNA load and E6/E7 mRNA detection in cervical samples: results from a multicenter study. J Med Virol. 2013 Mar;85(3):472-82. Epub 2012 Dec 26.

Andersson S, Mints M, Weiderpass E, Johansson B. Human papillomavirus DNA and E6/E7 mRNA testing as triage in liquid-based cytology samples from primary screening. Curr Pharm Des. 2013;19(8):1508-15.

Sørbye SW, Fismen S, Gutteberg TJ, Mortensen ES, Skjeldestad FE. HPV mRNA testing in triage of women with ASC-US cytology may reduce the time for CIN2+diagnosis compared with repeat cytology. Curr Pharm Des. 2013;19(8):1401-5.

Dixon EP, Grønn P, King LM, Passineau H, Doobay H, Skomedal H, Hariri J, Hay SN, Brown CA, Fischer TJ, Malinowski DP. Analytical performance of RNA isolated from BD SurePath™ cervical cytology specimens by the PreTect™ HPV-Proofer assay. J Virol Methods. 2012 Nov;185(2):199-203. Epub 2012 Jul 20.

Rijkaart DC, Heideman DA, Coupe VM, Brink AA, Verheijen RH, Skomedal H, Karlsen F, Morland E, Snijders PJ, Meijer CJ. High-risk human papillomavirus (hrHPV) E6/E7 mRNA testing by PreTect HPV-Proofer for detection of cervical high-grade intraepithelial neoplasia and cancer among hrHPV DNA-positive women with normal cytology. J Clin Microbiol. 2012 Jul;50(7):2390-6. Epub 2012 May 2.

Tropé A, Sjøborg KD, Nygård M, et al. Cytology and Human Papillomavirus Testing 6 to 12 Months after ASCUS or LSIL Cytology in Organized Screening To Predict High-Grade Cervical Neoplasia between Screening Rounds. Journal of Clinical Microbiology 2012;50(6):1927-1935.

Szarewski A, Mesher D, Cadman L, Austin J, Ashdown-Barr L, Ho L, Terry G, Liddle S, Young M, Stoler M, McCarthy J, Wright C, Bergeron C, Soutter WP, Lyons D, Cuzick J. 2012 A comparison of seven tests for high grade cervical intraepithelial neoplasia in women with abnormal smears: the Predictors 2 study. J. Clin. Microbiol. JCM.00181-12; published ahead of print 14 March 2012.

Sørbye SW, Arbyn M, Fismen S, Gutteberg TJ, Mortensen ES, 2011 HPV E6/E7 mRNA Testing Is More Specific than Cytology in Post-Colposcopy Follow-Up of Women with Negative Cervical Biopsy. PLoS ONE 6(10): e26022. doi:10.1371/journal.pone.0026022.

Sørbye SW, Arbyn M, Fismen S, Gutteberg TJ, Mortensen ES (2011) Triage of Women with Low-Grade Cervical Lesions – HPV mRNA Testing versus Repeat Cytology. PLoS ONE 6(8): e24083. doi:10.1371/journal.pone.0024083.

Tropé A, Jonassen CM, Sjøborg KD, Nygård M, Dahl FA, Alfsen GC, Lie AK (2011) Role of high-risk human papillomavirus (HPV) mRNA testing in the prediction of residual disease after conisation for high-grade cervical intraepithelial neoplasia. Gynecol Oncol. 2011 Nov;123(2):257-62. Epub 2011 Aug 12.

Ovestad IT, Vennestrøm U, Andersen L, Gudlaugsson E, Munk AC, Malpica A, Feng W, Voorhorst F, Janssen EA, Baak JP (2011) Comparison of different commercial methods for HPV detection in follow-up cytology after ASCUS/LSIL, prediction of CIN2-3 in follow up biopsies and spontaneous regression of CIN2-3. Gynecol Oncol. 2011 Nov;123(2):278-83. Epub 2011 Aug 10.

Basu P, Chandna P, Bamezai RN, Siddiqi M, Saranath D, Lear A, Ratnam S (2011) MassARRAY spectrometry is more sensitive than PreTect HPV-Proofer and consensus PCR for type-specific detection of high-risk oncogenic human papillomavirus genotypes in cervical cancer. J Clin Microbiol. 2011 Oct;49(10):3537-44. Epub 2011 Aug 3.

Benevolo M, Vocaturo A, Caraceni D, French D, Rosini S, Zappacosta R, Terrenato I, Ciccocioppo L, Frega A, Giorgi Rossi P (2011) Sensitivity, specificity, and clinical value of human papillomavirus (HPV) E6/E7 mRNA assay as a triage test for cervical cytology and HPV DNA test. J Clin Microbiol. 2011 Jul;49(7):2643-50. Epub 2011 Apr 27.

Sørbye SW, Fismen S, Gutteberg T, Mortensen ES (2010) Triage of Women with Minor Cervical Lesions: Data Suggesting a “Test and Treat” Approach for HPV E6/E7 mRNA Testing. PLoS ONE 5(9): e12724. doi:10.1371/journal.pone.0012724.

Sorbye S.W. (2010) HPV mRNA test in women with minor cervical lesions: Experience of the University Hospital of North Norway, Journal of Virological Methods, Volume 169, Issue 1, October 2010, Pages 219-222.

Ratnam S, Coutlee F, Fontaine D, Bentley J, Escott N, Ghatage P, Gadag V, Holloway G, Bartellas E, Kum N, Giede C, Lear A (2010) Clinical performance of the PreTect HPV-Proofer E6/E7 mRNA assay in comparison with that of the Hybrid Capture 2 test for identification of women at risk of cervical cancer. J Clin Microbiol. 2010 Aug;48(8):2779-85. Epub 2010 Jun 23.

Hovland S, Muller S, Skomedal H, Mints M, Bergström J, Wallin KL, Karlsen F, Johansson B, Andersson S (2010) E6/E7 mRNA expression analysis: a test for the objective assessment of cervical adenocarcinoma in clinical prognostic procedure. Int J Oncol. 2010 Jun;36(6):1533-9.

Hovland S, Arbyn M, Lie AK, Ryd W, Borge B, Berle EJ, Skomedal H, Kadima TM, Kyembwa L, Billay EM, Mukwege D, Chirimwami RB, Mvula TM, Snijders PJ, Meijer CJ, Karlsen F (2010) A comprehensive evaluation of the accuracy of cervical pre-cancer detection methods in a high-risk area in East Congo. Br J Cancer. 2010 Mar 16;102(6):957-65. Epub 2010 Mar 2.

Basu P et al. (2009) Human Papillomavirus Genotype Distribution in Cervical Cancer in India: Results from a Multi-center Study, Asian Pacific Journal of Cancer Prevention, Vol 10, 2009, 27-34.

Szarewski A et al. (2008) Comparison of Predictors for High-Grade Cervical Intraepithelial Neoplasia in Women with Abnormal Smears, Cancer Epidemiol Biomarkers Prev. 2008;17(11) November 2008.

Keegan H et al. (2008) Comparison of HPV detection technologies: Hybrid capture 2, PreTect HPV-Proofer and analysis of HPV DNA viral load in HPV16, HPV18 and HPV33 E6/E7 mRNA positive specimens, J Virol Methods.

Dixon EP et al. (2008) Isolation of RNA from residual BD SurePathtrade mark liquid-based cytology specimens and detection of HPV E6/E7 mRNA using the PreTecttrade mark HPV-Proofer assay, J Virol Methods. 2008 Sep 19.

Holm R et al. (2008) Human Papillomavirus DNA and E6/E7 mRNA Status in Relation to Survival of Patients Treated for Cervical Squamous Cell Carcinoma, The Open Virology Journal, 2008, 2, 74-81.

Kraus I et al. (2008) The Majority of Viral-Cellular Fusion Transcripts in Cervical Carcinomas Cotranscribe Cellular Sequences of Known or Predicted Genes. Cancer Res. 2008 Apr 1;68(7):2514-22.

Varnai A et al. (2008) Predictive testing of early cervical pre-cancer by detecting human papillomavirus E6/E7 mRNA in cervical cytologies up to high-grade squamous intraepithelial lesions: Diagnostic and prognostic implications. ONCOLOGY REPORTS 19: 457-465.

Rosini S et al. (2007) Management and triage of women with human papillomavirus infection in follow-up for low-grade cervical disease: Association of HPV-DNA and RNA-based methods. International Journal of Immunopathology and Pharmacology, Vol. 20, no. 2, 341-347.

Molden et al. (2007) PreTect™ HPV-Proofer: Real-time detection and typing of E6/E7 mRNA from carcinogenic human papillomaviruses. Journal of Virological Methods, Volume 142, Issues 1-2, June 2007, Pages 204-212.

Andersson S et al. (2006) Expression of E6/E7 mRNA from ‘high risk’ human papillomavirus in relation to CIN grade, viral load and p16INK4a. Int J Oncol. 2006 Sep;29(3):705-11.

Kraus I et al. (2006) Presence of E6 and E7 mRNA from Human Papillomavirus Types 16, 18, 31, 33, and 45 in the Majority of Cervical Carcinomas. Journal of Clinical Microbiology, April 2006, p. 1310-1317, Vol. 44, No. 4.

Molden T et al. (2005) Human papillomavirus E6/E7 mRNA expression in women younger than 30 years of age. Gynecol Oncol. 2006 Jan;100(1):95-100. Epub 2005 Sep 8.

Cuschieri K et al. (2005) Assessment of human papillomavirus mRNA detection over time in cervical specimens collected in liquid based cytology medium. J Virol Methods. 2005 Mar;124(1-2):211-5.

Lie AK et al. (2005) DNA VERSUS RNA BASED METHODS FOR HUMAN PAPILLOMAVIRUS DETECTION IN CERVICAL NEOPLASIA. Gynecologic Oncology, Volume 97, Issue 3 , June 2005, Pages 908-915.

Molden T et al. (2005) Predicting CIN2+ when detecting HPV mRNA and DNA by PreTect HPV-proofer and consensus PCR: A 2-year follow-up of women with ASCUS or LSIL pap smear. Int J Cancer. 2005 Jan 11;114(6):973-976.

Molden T et al. (2005) Comparison of Human Papillomavirus Messenger RNA and DNA Detection: A Cross-sectional Study of 4,136 Women >30 Years of Age with a 2-Year Follow-up of High-Grade Squamous Intraepithelial Lesion. Cancer Epidemiol Biomarkers Prev. 2005 Feb;14(2):367-72.

Cuschieri K et al. (2004) Human papillomavirus type specific DNA and RNA persistence -implications for cervical disease progression and monitoring. J Med Virol. 2004 May;73(1):65-70.

Kraus I et al. (2004) Human papillomavirus oncogenic expression in the dysplastic portio; an investigation of biopsies from 190 cervical cones. Br J Cancer. 2004 Apr 5;90(7):1407-13.