Pharma company Roche has been awarded World Health Organization (WHO) prequalification for its cobas HPV test. This move increases access to critical cervical cancer screening tools in low and lower-middle income countries, where the disease is most prevalent and deadly.

Each year, over 600,000 women around the world are diagnosed with cervical cancer, with more than 340,000 succumbing to the preventable disease, caused by the human papillomavirus (HPV). The majority of these deaths, nine out of ten, occur in low and lower-middle income countries.

The WHO prequalification allows these countries to integrate the cobas HPV test into their national cervical cancer elimination programs, making this life-saving diagnostic tool accessible to women who need it most. This will greatly aid in the establishment of screening programs, which are crucial for early detection and prevention of cervical cancer, especially in regions with limited healthcare resources.

Screening for HPV can help identify women at risk of developing cervical cancer. This is particularly important as early diagnosis and treatment significantly reduce the chances of the disease progressing into invasive cancer. In less affluent countries, where women are often diagnosed with cervical cancer at an advanced stage, the opportunity for a cure is unfortunately much lower.

Matt Sause, CEO of Roche Diagnostics, notes: “The elimination of cervical cancer is within reach. Roche is committed to working with governments, non-profit organisations and funders to help build sustainable cervical cancer elimination programs so that women, no matter where in the world they live, no longer die from this preventable disease. Today’s action, combined with our recently-launched HPV-self sampling solution, further expands access to HPV screening in countries with limited healthcare resources.”

This achievement comes as part of Roche’s Global Access Program, launched in 2014, which has been continually expanding its offering to combat high-burden diseases like Tuberculosis, Hepatitis B and C, cervical cancer, and most recently, COVID-19. Roche’s commitment to improving access to healthcare in resource-constrained settings has led to the expansion of the cobas HPV test, fostering confidence among healthcare professionals that their clinical decisions are supported by accurate and reliable results.

The cobas HPV test is a cutting-edge tool for routine cervical cancer screening. It detects high-risk HPV types responsible for about 70% of all cervical cancers and reports the 12 other high-risk HPV types as a combined result from one patient sample. This test can be used in conjunction with other screening methods for a comprehensive overview of a patient’s risk for cervical precancer and cancer.

In 2022, Roche introduced an HPV self-sampling solution, allowing women to privately collect their own sample under the guidance of a healthcare worker. This move has made testing more accessible and convenient for many women, providing them with the ability to take an active role in their own healthcare.

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