Roche  announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline. The Roche CINtec PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.

The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy.

However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures.

“Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology test to identify patients with an elevated risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “HPV infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk.”