The World Health Organization (WHO) has updated its cervical cancer prevention guidelines to include Roche’s CINtec PLUS Cytology test, a dual-stain cytology test for individuals at high risk of developing cervical precancer and cancer. This test, which detects the biomarkers p16 and Ki-67 within the same cell, helps identify potential cellular transformation into cancer.
A positive dual-stain result indicates a higher risk of cervical cancer, prompting immediate colposcopy, while a negative result suggests low risk, allowing for retesting later. The test uses the same liquid sample collected for HPV or Pap cytology tests, eliminating the need for additional samples.
Roche’s CINtec PLUS Cytology test, already approved by the FDA and CE-marked, provides valuable information for clinicians, patients, and laboratories, helping reduce unnecessary follow-up visits and associated costs. The recent WHO endorsement follows an earlier update by the American Society for Colposcopy and Cervical Pathology (ASCCP), which also included dual-stain cytology as a triage test for HPV-positive individuals.
Roche Diagnostics CEO, Matt Sause, highlighted the importance of the test in identifying those at elevated risk for cervical cancer, noting that HPV infections are a leading cause of this highly preventable disease. This WHO guideline update further strengthens Roche’s portfolio, which includes its cobas HPV test on various platforms for both clinician-collected and self-collected samples.
This update marks another step forward in cervical cancer prevention, allowing for more accurate risk assessment and improved patient management.