TEST:

CINtec® PLUS Cytology

However, the model had 96% sensitivity, 25% specificity, and 0.58 AUC for CIN3 prediction. Patient characteristics and risk factors can influence CINtec® PLUS positivity rates and they need to be carefully considered before choosing a specific management.

All three high-grade lesions were in the DS positive category, suggesting DS may help in the risk stratification for HPV-positive NILM women (either HPV16/18 or other). Furthermore, DS may help with risk stratification, specifically in patients with no prior high-grade lesions.

P=N/A, N=500, Recruiting, Lisa Flowers | Not yet recruiting --> Recruiting

This review examines the role of the cytology CINtecPlus®-test (Dual Stain (DS)-test) as a triage marker to identify patients with CIN2+ lesions among HPV + tested women and summarizes the most recent recommendations for its clinical use.

Despite the limitations of our study, it provides a foundation for further research into the long-term benefits and cost-effectiveness of this test. Future studies could explore its potential for integration into national screening programs.

P=N/A; N=500; Not yet recruiting; Sponsor:Lisa Flowers

"Roche...announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer."

We calculated the predictive performance of individual tests (cervical cytology, HPV genotyping, CINtecPlus results, and clinical risk factors) or their combination in the prediction of cervical lesion progression, regression, and persistence; (3) The highest predictive performance for the progression of cervical lesions was achieved by a model comprising a Pap smear suggestive of high-grade squamous intraepithelial lesion (HSIL), the presence of 16/18 HPV strains, a positive p16/Ki67 dual staining result along with the presence of at least three clinical risk factors, which had a sensitivity (Se) of 74.42%, a specificity of 97.92%, an area under the receiver operating curve (AUC) of 0.961, and an accuracy of 90.65%. The prediction of cervical lesion regression or persistence was modest when using individual or combined tests; (4) Multiple testing or new biomarkers should be used to improve HPV-positive patient surveillance, especially for cervical lesion regression or persistence prediction.

The p16 marker (CINtec® PLUS) can be used as a prognostic biomarker and provides clinical usefulness through increased sensitivity (Se) and specificity (Sp) in the triage of women at risk of developing precancerous lesions, compared to cytology that is based on morphology, but has a rather low Se and high Sp, while HPV testing is very sensitive but slightly more specific.

"Roche Diagnostics today announced the release of new guidelines from ASCCP and other members of the Enduring Guidelines for Cervical Cancer Screening and Management Committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus (HPV) infection is transforming into cervical pre-cancer."

Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.

All three High-grade lesions were in the CINtec® PLUS positive category, suggesting CINtec® PLUS might help risk stratification for HPV-positive NILM women in both HPV16/18 vs. other HPV. Furthermore, CINtec® PLUS might be of help for risk stratification specifically in patients with no prior high-grade lesions.