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Scientific publications

(1) Mehlhorn G, et al. 2014, HPV16-L1-specific Antibody Response Is Associated with Clinical Remission of High-risk HPV-positive Early Dysplastic Lesions.

Anticancer Research 34: 5127-5132

The publication shows that detection of HPV16 L1 specific antibodies, as a sign of HPV specific immunocompetence is strongly associated with remission of mild and moderate dysplasia. The risk of progression to CIN3 in women who are L1 protein and HPV16 L1 antibody double positive is extremely low (6%) and also very rarely (8.7%) associated with a CIN lesion at follow-up.

(2) S.-J. Lee, A.-W. Lee, C.-S. Kang, J.-S. Park, D.-C. Park, E.-Y. Ki, K.-H. Lee, J.-H. Yoon, S.-Y. Hur, T.-J. Kim, 2014, Clinicopathological Implications of Human Papilloma Virus (HPV) L1 Capsid Protein Immunoreactivity in HPV16 – Positive Cervical Cytology. International Journal of Medical Sciences, 11(1):80-86. Doi: 10.7150/ijms.5585

The study shows, on the basis of 475 HPV16 positive conspicuous smears, that the expression of HPV-L1 protein decreases with the severity of dysplasia. Furthermore, the absence of HPV L1 in HPV16-positive low-grade cytologies (such as ASCUS and LSIL) was strongly associated with high-grade histopathologic diagnoses (> CIN2+). All 23 HPV16 positive ASCUS cases later confirmed as CINII were L1 negative. This means that the cytoactiv test is also highly informative for the IIP cases of the new Munich Nomenclature 3.

(3) Mehlhorn G, et al. 2013, HPV L1 detection discriminates cervical precancer from transient HPV infection: a prospective international multicenter study. Nature-Modern Pathology, 26, 967-974

Prospective, international multicenter study of 908 non-therapy HPV high risk positive mild (LSIL) and moderate (HSIL) dysplasias with patient follow-up of up to 54 months. The results of the previous studies are confirmed and supported by this study. Only about 20% of L1 capsid protein positive cases showed progression to histologically confirmed CIN3 lesion, whereas progression occurred in 84% of L1 negative cases. The study shows that Cytoactiv allows a clear differentiation between transient HPV high risk infections and progressively behaving precancerous lesions.

(4) S. W. Byun, A. Lee, S. Kim, Y. J, Choi, Y. S. Lee, J. S. Park, 2013, Immunostaining of p16INK4a /Ki-67 and L1 Capsid Protein on Liquid-based Cytology Specimens Obtained from ASC-H and LSIL-H Cases, International Journal of Medical Sciences

This study investigates the detection of p16 INK4a /Ki-67, L1 capsid protein, and HPV DNA typing using monolayer techniques in ASC-H and LSIL-H patients to determine the most useful combination of biomarkers.

The combination of p16 INK4a /Ki-67 (CinTecPlus) and L1 capsid protein (Cytoactiv) were superior to all other combinations to predict progression.

(5) R. Hilfrich PhD, 2013, HPV L1 Detection as a Prognostic Marker for Management of HPV High Risk Positive Abnormal Pap Smears, Book InTech – Human Papillomavirus and related diseases; from bench to bedside – a diagnostic and preventive perspective

This book chapter summarizes the complete scientific data on the management of conspicuous smears with the prognostic marker Cytoactiv.

(6) G. Böhmer, Th. Weyerstahl, 2012, Clarification of abnormal findings of the cervix uteri in the context of cancer screening, Thieme Frauheilkunde up2date.

This review article summarizes the current data on the management of abnormal findings in cancer screening. In particular, a clear distinction is made between Cytoactiv as a PROGNOSEMARKER, and CinTectPlus, which is presented only as a biomarker.

(7) S.J. Lee et al. 2011, Correlation between immunocytochemistry of human papilloma virus L1 capsid protein and behavior of low-grade cervical cytology in Korean women, Journal of Obstetrics and Gynaecology Research

This prospective study of 318 women confirms the benefit of Cytoactiv in the management of HPV high risk positive LSIL. The positive predictive value of HPV L1-positive cases not progressing is reported to be 91.7%.

(8) M.T. Galgano et al. 2010, Using Biomarkers as Objective Standards in the Diagnosis of Cervical Biopsies, Am J Surg Pathol.

In this diagnostic study, the very high specificity of Cytoactiv of 96.7% is demonstrated on 748 samples. In addition, the low interobserver variability and high reproducibility of Cytoactiv (96.9% and 0.88 kappa) is highlighted just in comparison to p16INK4a (76.5%, 0.64) and ki67 (73.6%, 0.55).

(9) Y.S. Choi et al, 2010, Human Papillomavirus L1 Capsid Protein and Human Papillomavirus Type 16 as Prognostic Markers in Cervical Intraepithelial Neoplasia 1, Int Jour of Gynecol Cancer

The first Korean study of 101 women who had HPV high-risk positive CIN1 lesions demonstrates that HPV L1 detection with Cytoactiv is strongly correlated with spontaneous remission of the disease.

(10) Griesser H, Sander H, Walczak C, Hilfrich R. 2009.HPV vaccine protein L1 predicts disease outcome of high-risk HPV+ early dysplastic lesions. Am J Clin Pathol

The prospective study of 211 nontherapeutic HPV high-risk positive mild to moderate dysplasias was conducted in Dec. Completed in 2008, with patient follow-up ranging from 36 – 48 months. The results of the previous studies are confirmed and supported by this study. Depending on the age of the patients ( < 30 / >30) and the severity of the change (mild or moderate dysplasia), progression was observed in only about 20% of L1 capsid protein positive cases, whereas in L1 negative cases progression occurred in up to 97%.

(11) Scheidemantel et al. 2008, Expression pattern of HPV L1 capsid protein in PAP tests: a potential biomarker in risk assessment for high grade SIL lesion. Abstract Ann. M. Am. Soc. of Cytopathology

The first ThinPrep study from the US on 111 HR-HPV positive cases shows that the Cytoactiv positive cases never showed progression. All progressive cases were cytoactiv negative.

(12) Negri G et al. 2008, p16 andHPV immunohistochemistry is helpful for estimating the behaviour of low grade dysplastic lesions of the cervix uteri. AmJ SurgPathol

This Italian study confirms the utility of Cytoactiv in assessing the progression of dysplasia. At the same time, it confirms that the combination with p16 is as useful as HPV High risk detection.

(13) Hilfrich R, Hariri J, 2008. Prognostic relevance of HPV L1 capsid protein detection within mild to moderate dysplastic lesions of the cervix uteri in combination with a second biomarker p16. Anal Quant Cytol Histl

This Danish study on 191 bone biopsies (CIN I/II) shows that the Cytoactiv procedure also provides comparable results on histological specimens. 83.9% of L1 capsid protein negative cases showed progression of precancerous lesions, but only 27.5% of L1 positive cases (p-value < 0.001). Compared with p16, only L1 capsid protein detection has prognostic value. The specificity of L1 detection is 100%.

(14) Rauber D et al. 2008. Prognostic significance of the detection of the human papillomavirus L1 protein in smears of mild to moderate cervical intraepithelial lesions. Eur J Obstet Gyn Reprod Biol

In this retrospective study of 279 HPV high risk positive, mild and moderate dysplasias (Pap IIID), comparable results were found regarding the valence of the L1 capsid protein. Only 12.3% of L1 capsid protein positive cases showed progression (p-value < 0.001).