Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results

Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer

This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)’s recent inclusion of dual-stain testing in cervical cancer screening guidelines, as well as other WHO prequalifications of Roche’s cobas HPV test

Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.

The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy. However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures.

“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,” said Matt Sause, CEO of Roche Diagnostics. “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.”

The CINtec PLUS Cytology test can simultaneously detect when two biomarkers (p16 and Ki-67) are present within the same cell – a strong indicator that it is undergoing transformation and may turn cancerous. By identifying those individuals who are at higher risk of developing cervical disease, CINtec PLUS Cytology helps provide labs, clinicians and patients with important information to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing, eliminating the need for additional or repeat sample collection.

The revised WHO guidelines represent an important step forward in achieving the organisation’s three cervical cancer elimination goals3, and a catalyst for ensuring that 90% of those identified with cervical disease receive appropriate treatment. With the recent news that the WHO has awarded prequalification designation to the cobas® HPV test on the cobas 4800, Roche’s entire portfolio of HPV tests on the 4800, 5800, 6800 and 8800 systems is now WHO prequalification-approved for both clinician-collected and self-collected samples

About the Roche Cervical Cancer Portfolio

HPV is the known cause of more than 95% of all cervical cancers.4 Roche’s cervical cancer portfolio includes the cobas HPV test, used for primary screening and co-testing. While Pap cytology can potentially detect abnormalities in the cervix, cobas HPV detects 14 types of high-risk HPV genotypes that put patients at higher risk of developing cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.3

The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain cytology product and CINtec Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions. The CINtec PLUS Cytology test can run on the BenchMark ULTRA IHC/ISH system. In countries accepting the CE mark, the CINtec PLUS Cytology test can be used to triage HPV-positive results.

The IMPACT trial, used to validate the clinical performance of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.5 This diversity was critical to accurately assess the performance of the cobas HPV test and dual stain cytology in patient populations with higher incident rates of HPV. Learn more now: http://diagnostics.roche.com.

Roche is piloting a disease management software called navify® Cervical Screening. It aims to support health systems to increase adherence to clinical guidelines, reduce under- and over-testing and optimise healthcare resources with an organised approach to screening.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan