The Roche Cervical Cancer Portfolio provides three clinically validated tests to help identify women at risk of cervical cancer and improve detection and confirmation of high-grade disease in a single round of screening. Our portfolio of proven molecular and tissue-based tests utilizes the science of HPV and biomarker technology to deliver highly sensitive and specific results, helping bring more clarity of answers for clinical decisions.
We understand how important it is for laboratory professionals to support healthcare providers and patients with accurate results. As the HPV-vaccinated population continues to grow, it will be increasingly difficult to detect patients at high risk of developing cervical cancer. To combat this challenge, labs need the automation, throughput, and quality control found in our products to confidently handle primary screening volume and protect women from developing cervical cancer. The science, clinical proof, and biomarker technology behind our portfolio delivers simplicity, safety, and efficiency currently missing from older testing options.
Screening with HPV DNA can identify women at risk for cervical cancer. The cobas® HPV test is the first clinically validated, FDA-approved, CE-IVD marked HPV DNA test for all cervical screening indications: primary screening, ASC-US triage and co-testing. cobas® HPV simultaneously provides pooled results on known high-risk HPV genotypes and individual results on the two highest-risk genotypes, HPV 16 and HPV 18, giving three results in one from a single sample.
Based on biomarker technology, CINtec® PLUS Cytology can help determine whether cells are undergoing oncogenic transformation. CINtec® PLUS Cytology dual-stain simultaneously detects p16 and Ki-67; it is abnormal for these two biomarkers to occur together in a single cell. A positive dual stain result indicates an increased risk for cervical disease caused by an HPV infection.
Diagnose with CINtec® Histology, the only clinically validated test that uses advanced p16 biomarker technology to confirm the presence or absence of cervical lesions due to transforming HPV infection. CINtec® Histology enhances the identification of occult cervical lesions that may be missed by H&E or morphological interpretation alone and is useful in evaluation of differential diagnostic cases.