CINtec® PLUS Cytology

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

CINtec PLUS Cytology is powered by dual-stain biomarker technology that detects the simultaneous presence within a single cell of two biomarkers: p16 & ki67.  The co-expression of the two biomarkers provide a strong indicator of the presence of a transforming HPV infection and that a woman may be at a higher risk for cervical disease.

CINtec PLUS Cytology is performed from the same ThinPrep sample as HPV and Pap tests, and run on the BenchMark ULTRA platform.

CINtec PLUS Cytology stains
CINtec® PLUS Cytology:
  • Finds more disease in HPV positive women either as a triage test in primary HPV screening or Pap/HPV co-testing
  • Substantially lowers the risk of missed disease in HPV positive women
  • Provides greater confidence to clinicians about choosing the right management path for their patients
  • Offers greater reassurance for those women who are told to come back for re-testing

CINtec PLUS Cytology Intended Uses:

  • Women 25 – 65 years old with 12 Other High Risk (HR) HPV positive test results using the cobas® 4800 HPV Test in primary HPV screening, to determine the need for referral to colposcopy.
  • Women 25 - 65 years old with HPV16/18 positive test results using the cobas® 4800 HPV Test in primary HPV screening where the CINtec PLUS Cytology test results will be used in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.
CINtec_PLUS_Triage_Test2

*For HPV16/18+ use as additional information in conjunction with the physician's assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.

Results from the CINtec PLUS Cytology test should be interpreted by a qualified pathologist.

 
 
 
  • Women 30 – 65 years old with NILM (Negative for Intraepithelial Lesion or Malignancy) and 12 Other HR HPV positive test results using the cobas® 4800 HPV Test in adjunctive cervical cytology and HR HPV screening, to determine the need for referral to colposcopy.
  • Women 30- 65 years old with NILM (Negative for Intraepithelial Lesion or Malignancy) and HPV16/18 positive test results using the cobas® 4800 HPV Test in adjunctive cervical cytology and HR HPV screening where the CINtec PLUS Cytology test results will be used in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.
CINtec_PLUS_Triage_Test3

*For HPV16/18+ use as additional information in conjunction with the physician's assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.

Results from the CINtec PLUS Cytology test should be interpreted by a qualified pathologist.

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

CINtec PLUS Cytology is run on the BenchMark ULTRA.  The BenchMark ULTRA system is a fully automated immunohistochemistry and in situ hybridization slide staining system, offering multiple features designed to provide diagnostic confidence to histopathology laboratories worldwide. With 30 independent slide drawers, the system gives histotechnologists continuous random access and supports single-piece workflow, which numerous studies have shown improves laboratory operational efficiency.

benchmark-ultra
Key resources to learn more

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

  1. CINtec PLUS Cytology package insert.
  2. 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.
  3. 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.