Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the World Health Organization (WHO) has included dual-stain cytology testing in its updated cervical cancer prevention guidelines. The Roche CINtec® PLUS Cytology test is currently the only FDA-approved and CE-marked dual-stain test designed to identify human papillomavirus (HPV)-positive individuals who are at the highest risk of developing cervical precancer or cancer.
This update from the WHO follows a similar decision made by the American Society for Colposcopy and Cervical Pathology (ASCCP) in March, which also incorporated dual-stain testing as a triage option for HPV-positive patients. A positive dual-stain test indicates an elevated risk of precancer or cancer, prompting the need for immediate colposcopy. Conversely, a negative result suggests a lower risk, allowing patients to potentially avoid unnecessary colposcopy procedures and instead monitor their status through follow-up testing to see if their body has naturally resolved the infection.
“WHO’s inclusion of dual-stain cytology testing in its guidelines further underscores the value of our CINtec PLUS Cytology test in identifying patients with an increased risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “Since HPV infections are a leading cause of cervical cancer, which is preventable, it’s vital to determine which patients are at the highest risk.”
The CINtec PLUS Cytology test detects two biomarkers, p16 and Ki-67, within the same cell, a strong indicator of cellular transformation that may lead to cancer. By identifying high-risk patients, the test provides critical information that helps guide clinical decisions, potentially reducing the number of follow-up visits and unnecessary treatments, ultimately saving patients time, stress, and money. The test can be conducted using the same liquid sample collected for HPV or Pap cytology testing, simplifying the process and avoiding the need for additional samples.
The WHO’s updated guidelines are a significant step toward achieving the organization’s goals of eliminating cervical cancer, including ensuring that 90% of individuals diagnosed with cervical disease receive the appropriate treatment. This announcement also coincides with WHO’s prequalification of Roche’s cobas® HPV test on the cobas 4800 system, meaning that Roche’s entire portfolio of HPV tests on the 4800, 5800, 6800, and 8800 systems is now WHO prequalification-approved for both clinician- and self-collected samples.
