Roche Diagnostics announced the release of new guidelines from ASCCP and other members of the Enduring Guidelines for Cervical Cancer Screening and Management Committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus (HPV) infection is transforming into cervical pre-cancer.
Roche’s CINtec PLUS Cytology is an FDA-approved dual-stain triage test for HPV-positive cervical cancer screening results.
Dual stain is a robust marker of CIN3+ risk and can be incorporated into clinical management strategies, according to the guidelines. Existing clinical decision support tools (e.g., the ASCCP app) plan to incorporate these recommendations for use of DS.
The guidelines examine data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study and outline new recommendations on how to manage patients using dual-stain technology. The guidelines also note that compared with cytology, dual stain requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or greater earlier.
CINtec PLUS Cytology detects the simultaneous presence within a single cell of the p16 and Ki-67 biomarkers, which are associated with HPV infections that are transforming and may lead to cervical cancer. A positive test result signals that a patient has a significantly higher risk for the disease. The dual-stain test is performed with the same sample as used for HPV or Pap cytology tests, so it does not require a repeat office visit for the patient.
