CINtec® PLUS Cytology

Be certain – Triage with CINtec® PLUS Cytology

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Abnormal cytology can’t hide anymore with CINtec® PLUS Cytology*

Unique dual-biomarker technology makes you certain about the presence of transforming HPV infection.

CINtec® PLUS Cytology is the only test that uses dual-biomarker technology to simultaneously detect p16 and Ki-67 to provide a strong indicator of the presence of transforming HPV infections.

Co-expression of p16 and Ki-67 in the same cell is strongly associated with established high-grade disease.

Clinical study excellence

T.C. Wright Jr. et al., Triaging HPV-Positive Women with p16/Ki-67 Dual-stained Cytology: Results from a Sub-study Nested into the ATHENA Trial. Gynecologic Oncology 144 (2017) 51–56.

A retrospective study comparing the results of CINtec® PLUS Cytology vs. Pap cytology triage of HPV (+) test results from a subset of samples collected in the ATHENA Trial. Results are correlated to histology follow-up reported in the ATHENA data.

  • CINtec® PLUS Cytology triage of either the other 12 high-risk HPV genotypes in combination with 16/18 genotyping, or of Pooled HPV (+) results identified more cervical disease with the same to fewer colposcopies compared to Pap cytology triage.
  • CINtec® PLUS Cytology is significantly more sensitive than Pap cytology when used for the triage of all HPV (+) screening results, with comparable specificity
  • When used together with HPV 16/18 genotyping as a triage of cobas® HPV (+) women, CINtec® PLUS Cytology detects significantly more cervical disease than Pap cytology, without increasing the number of colposcopies
  • Triaging all HPV (+) women with CINtec® PLUS Cytology leads to the lowest number of colposcopies needed per cervical disease detected
  • Read the ATHENA publication here

Ikenberg, H. et al., Screening for Cervical Cancer Precursors With p16/Ki-67 Dual-Stained Cytology: Results of the PALMS Study. J Natl Cancer Inst. 2013 Oct 16; 105(20): 1550–1557.

The PALMS study (Primary ASC-US and LSIL Marker Study) validated the CINtec® PLUS Cytology test in 27,349 women from five European countries enrolled in the prospective study to show performance of Pap cytology, p16/Ki-67 immunostaining and HPV testing. Presence of ≥CIN2 disease on adjudicated histology was used as the reference standard.

  • In women of all ages, CINtec® PLUS Cytology was more sensitive than Pap cytology (86.7% vs 68.5%) for detecting ≥CIN2 disease with non-inferior specificity (95.2% vs. 95.4%)
  • In young women (18-29), CINtec® PLUS Cytology was more sensitive than Pap cytology with non-inferior specificity (92.0% vs. 92.6%)
  • Read the PALMS study here
cobas® HPV Test with CINtec® PLUS Cytology triage could lead to improved clinical outcomes
  • Clinicians use screening and triage test to identify the risk of disease and can manage women based on their level of risk.
  • Various combinations of screening and triage tests can result in differences in disease detection and the number of colposcopies required.
  • A strategy that results in more disease detection without increasing the colposcopy rate can aid clinicians making decisions that result in improved clinical outcomes and lower healthcare costs.
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CINtec® PLUS Cytology:
 
  • Helps ensure women are not lost to follow-up by providing immediate and actionable triage results
  • Reduces both the number and frequency of follow-up visits required
  • Gives women clear answers and certainty in their test results
CINtec® PLUS Cytology is a triage test for cervical cancer screening

 

  1. An objective biomarker test to help triage Pap cytology screening results
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2. An objective biomarker test to help triage Pap negative/HPV (+) co-testing results

 

Improve management of women with Pap cytology negative/HPV (+) results: In co-testing, CINtec® PLUS Cytology provides immediate and actionable results to help reduce the number of women lost to follow-up testing.

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3. CINtec® PLUS Cytology outperforms Pap cytology as the triage test for HPV (+) screening results



Improved cervical cancer screening strategy: Primary screening by the cobas® HPV DNA test with triage using the CINtec® PLUS Cytology test demonstrates high sensitivity and specificity to detect transforming HPV infections and helps avoid unnecessary colposcopy for women who do not need it.

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CINtec® PLUS Cytology reduces diagnostic variability and uncertainty to impact timely patient management
  • The test indicates oncogenically transforming HPV infections, and thus eliminates equivocation over morphologic abnormalities that are not pre-cancerous. Very good overall clinical accuracy has been demonstrated in key cervical cancer screening scenarios.
  • Overall, p16/Ki-67 dual staining has the potential to significantly reduce the number of women referred for confirmatory colposcopy.
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The CINtec® PLUS Cytology test efficiently triages ASC-US, LSIL, HPV(+) and HPV(+)/Pap cytology negative results
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The CINtec® PLUS Cytology test is included in cervical cancer screening guidelines: France, Germany, Hong Kong, South Africa, Portugal and Spain
Advanced dual-biomarker technology that integrates with automated testing procedures to improve efficiency
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CINtec PLUS Cytology stains
Key Publications to learn more

The following publications provide further evidence of the clinical utility of p16/Ki-67 dual staining in cervical cancer screening:

  1. Schmidt D, Bergeron C, Denton KJ, Ridder R for the European CINtec Cytology Study Group. p16/Ki-67 dual-stain cytology in the triage of ASCUS and LSIL papanicolaou cytology: results from the European equivocal or mildly abnormal Papanicolaou cytology study. Cancer Cytopathol. 2011;119(3):158-166. doi: 10.1002/cncy.20140. Epub 2011 Mar 25.
  2. Petry KU, Schmidt D, Scherbring S, et al. Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 dual-stained cytology. Gynecol Oncol. 2011;121(3);505-509. doi: 10.1016/j.ygyno.2011.02.033. Epub 2011 Mar 21.
  3. Killeen JL, Dye T, Grace C, Hiraoka M. Improved abnormal Pap smear triage using cervical cancer biomarkers. J Low Genit Tract Dis. 2014;18(1):1-7. DOI:10.1097/LGT.0b013e31828aeb39.
  4. Ikenberg, H. et al., Screening for Cervical Cancer Precursors With p16/Ki-67 Dual-Stained Cytology: Results of the PALMS Study. J Natl Cancer Inst. 2013 Oct 16; 105(20): 1550–1557.
  5. KU Petry et al., A model to evaluate the costs and clinical effectiveness of human papilloma virus screening compared with annual papanicolaou cytology in Germany. European Journal of Obstetrics & Gynecology and Reproductive Biology 212 (2017) 132–139.
  6. T.C. Wright Jr. et al., Triaging HPV-Positive Women with p16/Ki-67 Dual-stained Cytology: Results from a Sub-study Nested into the ATHENA Trial. Gynecologic Oncology 144 (2017) 51–56.Gynecol Oncol. 2017 Jan;144(1):51-56. doi: 10.1016/j.ygyno.2016.10.031.
  7. Bergeron, C. et al., Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormalPapanicolaou cytology: PALMS study results. Cancer Cytopathol. 2015 Jun;123(6):373-81. doi: 10.1002/cncy.21542. Epub 2015 Apr 17.
  8. Wentzensen N., et al., Performance of p16/Ki-67 Immunostaining to Detect Cervical Cancer Precursors in a Colposcopy Referral Population. Clin Cancer Res. 2012 Aug 1;18(15):4154-62. doi: 10.1158/1078-0432.CCR-12-0270. Epub 2012 Jun 6.
  9. Wentzensen N., et al., p16/Ki-67 Dual Stain Cytology for Detection of Cervical Precancer in HPV-Positive Women. J Natl Cancer Inst. 2015 Sep 15;107(12):djv257. doi: 10.1093/jnci/djv257. Print 2015 Dec.
  10. Waldstrøm, M., et al., Evaluation of p16INK4a/Ki-67 Dual Stain in Comparison With an mRNA Human Papillomavirus Test on Liquid-Based Cytology Samples With Low-Grade Squamous Intraepithelial Lesion. Cancer Cytopathol. 2013 Mar;121(3):136-45. doi: 10.1002/cncy.21233. Epub 2012 Sep 17.

*CINtec® PLUS Cytology is a CE/IVD product, approved for clinical use. CINtec® PLUS Cytology is not available for this use in the United States. Check with your local Roche representative for the availability of products in your region and the applicable intended use