Tuesday, July 16, 2024

Cervical Cancer Screening Enhanced as FDA Prequalifies Roche’s HPV Test for Global Use

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The U.S. Food and Drug Administration (FDA) granted prequalification designations to Roche’s human papillomavirus (HPV) test for cervical cancer screening use on the Cobas 5800 System and for self-collected samples on the Cobas 5800, 6800, and 8800 Systems. This builds on the previous WHO prequalification for the cobas HPV test on the Cobas 6800 and 8800 Systems, enhancing access in low- and middle-income countries (LMICs) for cervical cancer screening.

Every year, over 600,000 women are diagnosed with cervical cancer, and over 340,000 die from it. Notably, 90% of these deaths occur in LMICs. The new prequalification will facilitate the use of Roche’s HPV screening solutions, including self-collection, in national cervical cancer elimination programs, significantly increasing access to screening.

WHO Targets Cervical Cancer Elimination by 2030 with Roche’s Test Expanding Global Screening Access

The World Health Organization (WHO) aims to eliminate cervical cancer with a strategy ensuring that by 2030, 70% of women will be screened using a high-performance test by age 35 and again by age 45. Screening for HPV helps identify women at risk, allowing early treatment before cancer develops. The Cobas HPV test prequalification from WHO supports expanding access to accurate, reliable results for healthcare professionals globally.

Roche collaborates with health systems and governments in over 55 countries, enhancing access to HPV molecular testing. In Peru, a partnership with the Ministry of Health has led to over 300,000 women being tested for HPV, even in remote areas. Roche’s Global Access Program, initiated in 2014, also supports other high-burden diseases like HIV/AIDS, tuberculosis, and hepatitis, showcasing Roche’s dedication to improving global health.

Cervical Cancer

Roche’s Comprehensive Cervical Cancer Portfolio Enhances Early Detection and Diagnostic Accuracy

Roche’s cervical cancer portfolio includes the Cobas HPV test for primary screening and co-testing. It detects 14 high-risk HPV genotypes, including HPV 16 and HPV 18, which are critical for early cervical cancer detection. The portfolio also features the FDA-approved CINtec PLUS Cytology and CINtec Histology, enhancing diagnostic accuracy for pre-cancerous cervical lesions.

Founded in 1896, Roche is a pioneer in biotechnology and in-vitro diagnostics. The company focuses on personalized healthcare, combining diagnostics and pharmaceuticals with data insights to transform healthcare delivery. Recognized as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices, Roche strives to improve healthcare access globally in collaboration with local partners.


Resource: Roche, June 27, 2024

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