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 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.

• 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.