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, thus improving the management of HPV (+) women
  • 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 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 – 89.4% vs. 71.9% with non-inferior specificity (92.0% vs. 92.6%)
  • Read the PALMS study here

cobas® HPV test with CINtec® PLUS Cytology triage improves clinical outcomes

Precancerous cells can be identified during first screening visit. This improves clinical outcomes and lowers costs.

Source: Wright et al., Gyn Oncol 2017 and Petry et al., EJOGRB 2017. Data from model output in Germany.
*HPV 16/18 genotyping and triage of 12 other hrHPV

CINtec® PLUS Cytology:

  • Helps ensure women are not lost to follow-up
  • 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

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.

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

The ideal 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.

CINtec® PLUS Cytology reduces diagnostic variability and uncertainty to impact timely patient management

  • The test indicates oncogenic transformation, 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.
Scenario
Primary
screening4
ASC-US
triage1
LSIL
triage1
Pap negative/
hrHPV positive
triage2
Sensitivity87%
Specificity95%
NotesSignificantly higher sensitivity than Pap cytology with no sacrifice in specificity
Read morePALMS (Primary ASC-US LSIL Marker Study)Ikenberg et al. J Natl Cancer Inst. 2013;105(20):1550-1557).
Sensitivity92%
Specificity81%
NotesSensitivity comparable to hrHPV for ≥CIN 2 with significantly higher specificity
Read moreEEMAPS (European Equivocal or Mildly Abnormal Pap Cytology Study) Schmidt et al. Cancer Cytopathol. 2011; 119(3):158-166.
Sensitivity94%
Specificity68%
NotesSensitivity comparable to hrHPV with significantly higher specificity
Read moreEEMAPS (European Equivocal or Mildly Abnormal Pap Cytology Study) Schmidt et al. Cancer Cytopathol. 2011; 119(3):158-166.
Sensitivity92%
Specificity82%
NotesDetects virtually all ≥CIN 2; only 25% of cases referred to colposcopy
Read moreWolfsburg Study Petry et al. Gynecol Oncol. 121(3):505-509.

The CINtec® PLUS Cytology test efficiently triages ASC-US, LSIL and HPV (+) /Pap cytology negative results

The CINtec® PLUS Cytology test is included in guidelines: France, Germany, Hong Kong, South Africa, Portugal and Spain

Advanced dual-biomarker technology that integrates with automated testing procedures to improve efficiency

The CINtec® PLUS Cytology test can be performed using either conventional or liquid-based samples, so users get more definitive information from the samples they already collect.

*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.

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. Killen 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.

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