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Roche Broadens Availability of Cervical Cancer Screening Tools with Two New WHO Prequalification Designations, Including HPV Self-Collection

NextEdge Admin

27 Jun 2024

2 min 46 sec

Roche announced today significant advancements in their efforts to combat cervical cancer, with the World Health Organization (WHO) granting new prequalification designations for their cobas® HPV test. These designations now include use on the cobas® 5800 system and for self-collected samples across the cobas® 5800, 6800, and 8800 systems. This follows the recent FDA approval of Roche’s HPV self-collection solution and earlier WHO prequalification for the cobas HPV test on the cobas 6800/8800 systems.

Matt Sause, CEO of Roche Diagnostics, highlighted the critical impact of these developments, stressing, "No woman should die from this preventable disease." The WHO's strategic goals for cervical cancer elimination by 2030 aim for 70% of women to undergo high-performance HPV screening by ages 35 and 45, underscoring the importance of accessible and reliable testing solutions.

Roche’s collaboration with over 55 countries, including partnerships such as with the Peruvian Ministry of Health, has significantly expanded access to HPV testing. Notably, over 300,000 unscreened or underscreened women in remote regions like the Amazon rainforest have been reached through these efforts, leveraging Roche’s self-collection solution to improve screening rates.

The cobas HPV test is a cornerstone of Roche's Global Access Program, initially launched in 2014 to address high-burden diseases like HIV/AIDS, Tuberculosis, Hepatitis B and C, and now cervical cancer. This program reflects Roche's commitment to enhancing diagnostic access and outcomes in resource-limited settings, aligning with global health equity objectives.

Roche’s comprehensive cervical cancer portfolio includes the cobas HPV test, capable of detecting 14 high-risk HPV genotypes, complemented by advanced solutions like CINtec PLUS Cytology and CINtec® Histology. The portfolio’s efficacy is supported by the IMPACT trial design, ensuring robust clinical validation across diverse patient demographics.