CINtec^® PLUS Cytology

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., Triageing 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
• Triageing 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 improves clinical outcomes

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

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

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 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.

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