WHO Updates Cervical Cancer Prevention Guidelines with Dual-Stain Cytology

The World Health Organization (WHO) has updated its guidelines for cervical cancer (搜索)搜索该疾病 prevention, now including dual-stain cytology with the CINtec PLUS Cytology (搜索)搜索该药品 test. This update aims to improve the identification of individuals at higher risk of developing cervical precancer and cancer.

CINtec PLUS Cytology (搜索)搜索该药品 received FDA approval and CE marking as a test designed to identify human papillomavirus (HPV (搜索)搜索该疾病)-positive individuals who are most at risk of developing cervical precancer and cancer. The test detects the presence of both p16查看药品详情 and KI-67 (搜索)搜索该靶点 in a cell, biomarkers that indicate a cell is undergoing transformation and could become cancerous. Identifying these patients allows for appropriate management and intervention.

ASCCP's Recommendation

In March 2024, the American Society for Colposcopy and Cervical Pathology (ASCCP) also included CINtec PLUS Cytology (搜索)搜索该药品 as a triage test for HPV (搜索)搜索该疾病-positive individuals in its updated cervical cancer (搜索)搜索该疾病 screening guidelines. The guidelines recommend immediate colposcopy for patients with a positive dual-stain test. Those with a negative test may undergo retesting to determine if the infection and risk of precancer or cancer have been eliminated, potentially reducing unnecessary colposcopies.

Roche's Perspective

"Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology (搜索)搜索该药品 test to identify patients with an elevated risk of cervical cancer (搜索)搜索该疾病," said Matt Sause, chief executive officer of Roche查看公司主页 Diagnostics. "HPV (搜索)搜索该疾病 infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk."

The IMPACT Trial

The dual-stain test, along with Roche查看公司主页’s cervical cancer (搜索)搜索该疾病 portfolio, was evaluated in the IMPACT trial, a prospective, multicenter, cervical cancer screening study conducted in the United States. The trial enrolled 35,263 women between 25 and 65 years of age undergoing routine cervical cancer screening. Participants received liquid-based cytology and two PCR-based tests for high-risk HPV (搜索)搜索该疾病. Cervical biopsy and colposcopy were performed on women with abnormal Pap cytology, those positive for high-risk HPV per either of the PCR-based tests, and a random subset of women with negative Pap cytology and HPV tests.

The study excluded women who were pregnant, those without an intact uterus, and those unwilling to undergo a colposcopy or biopsy if necessary. Exclusion criteria also included treatment for cervical intraepithelial neoplasia (CIN (搜索)搜索该疾病) in the 12 months prior to the study, or enrollment/planned enrollment in another cervical cancer (搜索)搜索该疾病 screening study, an HPV (搜索)搜索该疾病 treatment study, or an HPV vaccine study.

In total, 34,914 enrolled patients met the study’s eligibility criteria, and 34,807 were evaluable following valid Pap cytology and 6800/8800 HPV (搜索)搜索该疾病 test results.

Key Findings from IMPACT

Findings showed that the prevalence of atypical squamous cells of undetermined significance was 6.5%, and the rate of worse-than-atypical squamous cells of undetermined significance was 3.2%. High-risk HPV (搜索)搜索该疾病, HPV16, and HPV18 were reported at rates of 15.1%, 3.1%, and 1.4%, respectively.

In women who underwent colposcopy and biopsy, grade 2 or higher CIN (搜索)搜索该疾病 was reported in 8.8% of participants, and grade 3 or higher CIN occurred in 3.6% of enrolled women. In women who tested positive for HPV16, the baseline and 1-year cumulative risks for grade 3 or higher CIN were 13.6% and 16.9%, respectively. Notably, women who tested negative for HPV (搜索)搜索该疾病 had a 1-year cumulative risk of grade 3 or higher CIN of 0.06%.

The IMPACT trial included a diverse patient population, with 21% Black, 24% Hispanic-Latino, and 0.3% American Indian or native Alaskan participants.