Biomarker Test Proves More Sensitive Than Pap in Detecting Cervical Pre-Cancer


he CINtec PLUS Cytology duel-stain biomarker technology was found to be more sensitive than Pap in detecting cervical precancer in women with HPV.

The CINtec PLUS Cytology dual-stain biomarker technology, a triage test for women who test positive for high-risk human papillomavirus (HPV), was found to demonstrate clear patient benefit in a trial of over 35,000 women between the ages of 25 and 65 years of age, according to a press release by Roche.

The CINtec PLUS Cytology test is designed to detect biomarkers p16 and Ki-67, which are typically associated with transforming HPV infections that can progress to pre-cancer or cancer if left untreated. The test is designed to identify women who have been diagnosed with HPV who are at a higher risk of cervical cancer.

"These latest results from the IMPACT trial confirm data from previous studies that show incorporating the CINtec PLUS Cytology test in cervical cancer screening programs can provide real benefits to both clinicians and their patients," said Thomas Wright, MD, professor emeritus in Pathology and Cell Biology at Columbia University Medical Center, New York, in a press release. "As a triage test for HPV-positive cervical cancer screening results, the CINtec PLUS Cytology test can be very useful to differentiate women who will benefit most from immediate referral to colposcopy from those women who can be followed up with less invasive methods.”

The test was studied in the IMPACT trial, which enrolled approximately 35,000 women between the ages of 25 and 65. It was conducted at 32 clinical sites across 16 states. The median age of the study population was 39, most were white, and most had more than a high school education. Most of the participants self-reported as having undergone Pap cytology in the past 5 years, with 84.9% of them reporting as normal. Additionally, 12.3% self-reported as receiving at least 1 dose of the HPV vaccine. Of those who reported being vaccination, 60% were between 25 and 29 years of age.

An analysis found that compared to Pap, the CINtec PLUS Cytology was more sensitive in detecting cervical pre-cancers. Pap detected the prevalence of atypical squamous cells of undetermined significance in 6.5% of patients, compared with the 15.1% picked up the CINtec PLUS.

“As we approach the one-year anniversary of the World Health Organization’s global strategy to accelerate the elimination of cervical cancer, Roche is committed to investing in and leading efforts such as the IMPACT trial to bring forth clinically validated solutions for women,” said Thomas Schinecker, CEO Roche Diagnostics, in a press release. “The elimination of cervical cancer is within reach, and all countries must act now so that women, no matter where in the world they live, no longer die from this preventable disease. Our investment in HPV primary screening and next-generation biomarker technology gives clinicians even more powerful tools in the fight against cervical cancer.”

IMPACT trial data shows clear benefit in using Roche's CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer. News release. Roche. October 29, 2021, Accessed November 1, 2021.
Safaeian M, Wright T, Stoler M, et al. The IMproving Primary Screening and Colposcopy Triage trial: human papillomavirus, cervical cytology, and histopathologic results from the baseline and 1-year follow-up phase. Am J Obstet Gynecol. 2021:225(3):278. doi: 10.1016/j.ajog.2021.03.047

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