Roche announced that results from the IMPACT (IMproving Primary screening And Colposcopy Triage) trial demonstrate clear patient benefit in using Roche’s CINtec PLUS Cytology dual-stain biomarker technology as a triage test for women who test positive for high-risk human papillomavirus (HPV), which can lead to cervical cancer. The data from the trial, established from a study cohort of more than 35,000 women aged 25-65 years, was published recently in the International Journal of Cancer.1

“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. “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.”

In the IMPACT trial, women who were positive for high-risk HPV received a follow-up triage test to help determine if their cervical cells were transforming to cervical pre-cancer. The biomarker-based CINtec PLUS Cytology test showed a significantly higher sensitivity in detecting cervical pre-cancers, compared to Pap cytology. The Roche test aids clinicians in more confidently determining which women are at increased risk for high-grade cervical pre-cancer and require immediate further diagnostic procedures, and which women may need repeat testing or routine screening.1

Over 604,000 women are diagnosed with cervical cancer worldwide each year and approximately 342,000 die from the disease.2 Persistent infection with high-risk HPV is the principal cause of cervical cancer, implicated in more than 99% of cases worldwide.3 Cervical cancer is nearly 100% preventable with proper HPV vaccination, screening and treatment.

“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,” says Thomas Wright, MD, professor emeritus in Pathology and Cell Biology at Columbia University Medical Center, New York. “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.”

Making an IMPACT on Cervical Cancer

Cervical cancer is nearly 100% preventable with proper HPV vaccination, screening and treatment. More than 604,000 new cases of cervical cancer are diagnosed each year worldwide. In 2020, cervical cancer was responsible for 7.7% of all female cancer deaths.2,4 

The landmark IMPACT trial was a prospective observational cervical cancer screening clinical study that enrolled approximately 35,000 women aged 25-65 years who were undergoing routine cervical cancer screening at 32 clinical sites in 16 states across the US. The study provides validation for the clinical utility of cobas HPV testing for primary screening in combination with CINtec PLUS Cytology as a follow-up test for patients with positive screening results. 

The study showed that triaging with CINtec PLUS Cytology may lead to significantly improved detection of cervical disease when women are screened for cervical cancer. Cervical screening helps identify women at risk for disease before invasive cancer develops. While most HPV infections resolve on their own, some women who test positive for the virus may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer. Early identification of women who are most at risk is vital.

In the study, HPV-positive women with CINtec PLUS Cytology negative triage test results showed a very low cumulative 1-year risk for disease, which was significantly lower than the risks associated with a negative Pap cytology triage test result in HPV-positive women.

Based on the results of the IMPACT trial, the FDA approved the CINtec PLUS Cytology test to be used as triage for positive HPV test results using cobas HPV on cobas 4800, 6800 and 8800 Systems in primary screening or co-testing programs.

Recommended clinical guidelines have also been evolving in favor of HPV tests for primary screening, supported by an interest to improve outcomes and the availability of technologies to help laboratories achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs.

CINtec PLUS Cytology Overview

The CINtec PLUS Cytology test detects the simultaneous presence within a single cell of the two biomarkers—p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease. The ability of CINtec PLUS Cytology to distinguish those women who are at a higher risk for cervical disease, in conjunction with the clinician’s assessment of patient screening history and other risk factors, provides labs, physicians and women with the information needed to guide patient management. Women with negative dual-stain results are at significantly lower risk for cervical disease and their bodies can be given more time to clear the HPV infection on their own. This could reduce the number and frequency of follow-up visits, saving some patients worry and time.

The CINtec PLUS Cytology test, which runs on the BenchMark ULTRA IHC/ISH system, is performed using the same sample that is used for HPV or liquid-based Pap cytology tests. This eliminates the need for additional or repeat sample collection or time spent waiting to find out if an infection is clearing.

CINtec PLUS Cytology, now available globally, was FDA approved in March 2020. 

To learn more visit Roche Diagnostics.

Featured Image: Roche’s CINtec PLUS Cytology has been shown to be beneficial for screening women with HPV who may be at risk for cervical caner. Photo: Roche Diagnostics

[1] Wright TC Jr, Stoler MH, Ranger-Moore J, Fang Q, Volkir P, Safaeian M, Ridder R. Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial. Int J Cancer. 2021 Sep 18. doi: 10.1002/ijc.33812. Online ahead of print.
[3] Walboomers JMM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathology. 1999;189(1):12–9.