CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 12, 2024—Roche Diagnostics announced the release of new guidelines from the American Society for Colposcopy and Cervical Pathology that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus infection is transforming into cervical precancer. Roche’s CINtec Plus Cytology is the only dual-stain test with FDA approval. It 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.
“For the first time, ASCCP has included dual-stain testing as an option for the triage of HPV-positive women in HPV primary screening and cotesting settings,” Laura Shields, chief medical partner of pathology oncology at Roche Diagnostics, said in a press release. “With more advanced technologies, such as dual stain, better access, and more awareness, we can change the course of this disease with earlier detection, save lives, and eventually eliminate cervical cancer.”