Roche’s dual-stain test received FDA approval and a CE mark for the identification of people at high risk of developing HPV-positive cervical precancer and cancer. Credit: NTshutterth / Shutterstock.

The World Health Organization (WHO) has updated its cervical cancer prevention guidelines to include dual-stain cytology testing with Roche’s CINtec PLUS Cytology test.

CINtec PLUS Cytology previously received FDA approval and a CE mark for the identification of people at high risk of developing cervical precancer and cancer among those who are human papillomavirus (HPV)-positive.

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The dual-stain test’s positive result indicates an increased pre-cancer or cancer risk, prompting immediate colposcopy, while a negative result suggests a low risk, allowing for retesting at a later date.

This test detects the presence of two biomarkers, p16 and Ki-67, within the same cell, indicating a potential transformation into a cancerous state.

It offers crucial information for laboratories, clinicians, and patients to make informed decisions about patient management, potentially reducing the need for follow-up visits and associated costs.

It can be performed using the same liquid sample collected for HPV or Pap cytology tests, avoiding the need for additional samples.

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The endorsement by WHO follows a similar update by the American Society for Colposcopy and Cervical Pathology (ASCCP) in March, which also included dual-stain cytology as a triage test for HPV-positive individuals.

Roche previously received WHO prequalification for its cobas HPV test on the cobas 4800 system, complementing its portfolio of HPV tests on the 4800, 5800, 6800, and 8800 systems, which are now approved for both clinician-collected and self-collected samples.

Roche Diagnostics CEO Matt Sause said: “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.

“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.”

In July this year, Roche completed the acquisition of LumiraDx‘s Point of Care technology for up to $350m.