Roche Diagnostics has reached a major milestone as the World Health Organisation (WHO) has granted pre-qualification to its cobas® HPV test for use on the cobas 5800, 6800, and 8800 systems, including for self-collected samples. This is big news for the global effort to fight cervical cancer, especially in low- and middle-income countries (LMICs), where access to quality healthcare is often limited.
Improving Access to Life-Saving Screening
The WHO pre-qualification process is vital because it confirms that a healthcare product meets strict global standards for quality, safety and effectiveness. For Roche, this recognition means that its cobas® HPV test can now be used in national cervical cancer screening programmes across LMICs. Given that 90% of cervical cancer deaths occur in these regions, it’s a breakthrough in ensuring that more women have access to early detection and potentially life-saving treatment. Perhaps the most exciting aspect of this news is the availability of self-sampling. For many women, barriers like distance to a clinic or cultural stigma can prevent them from attending regular screenings. The cobas® system now allows women to collect their own samples, which can then be analysed with the same accuracy as clinic-based tests. This not only improves access but also gives women more control over their healthcare.
Why This Matters Globally
Cervical cancer is primarily caused by high-risk strains of human papillomavirus (HPV). Early detection is critical because it allows for treatment before cancer develops. Yet, despite being largely preventable, over 340,000 women die from cervical cancer each year, with more than 600,000 diagnosed globally. The majority of these cases occur in LMICs, where healthcare systems often lack the resources for widespread screening.
WHO’s global strategy to eliminate cervical cancer aims to ensure that by 2030:
- 90% of girls are vaccinated against HPV by age 15.
- 70% of women are screened by age 35, and again by age 45.
- 90% of women diagnosed with cervical disease receive appropriate treatment.
Roche’s cobas® HPV test directly supports these goals by identifying women at risk for cervical cancer early. The test detects 14 high-risk HPV types, including types 16 and 18, which are responsible for about 70% of cervical cancers. Being able to screen accurately and efficiently is essential in preventing cervical cancer deaths
The pre-qualification of the cobas® HPV test is a game-changer for LMICs. These countries can now integrate advanced screening technologies like Roche’s into their national healthcare systems with confidence. In many LMICs, healthcare infrastructure is limited and the ability to use a WHO-approved test ensures that clinical decisions are based on reliable, accurate results. Additionally, the cobas® systems, which range in size and capacity (5800, 6800, and 8800), can be adapted to the needs of different laboratories. Whether it’s a small lab or a large regional centre, these systems offer flexibility while maintaining the same high standard of accuracy.
The Significance of WHO Prequalification
WHO pre-qualification isn’t just a stamp of approval—it’s a sign that a product meets the highest standards of quality, safety, and performance. Roche’s cobas® HPV test opens the door for it to be used in national screening programmes in countries that rely on the WHO list to guide their healthcare decisions. This is a major boost for healthcare providers in LMICs who now have a trusted and validated option for HPV screening.
Roche’s cobas® HPV test receiving WHO pre-qualification is a critical step in the global fight to eliminate cervical cancer. By expanding access to high-quality screening tools, especially in regions that need them most, this development helps pave the way towards WHO’s 2030 goals. The inclusion of self-sampling options is a particularly welcome feature, as it will help overcome logistical and cultural barriers that have previously limited access to screening. This means more women, especially in under-served areas, can be screened and treated early, preventing thousands of deaths each year. The road to eliminating cervical cancer is still long, but Roche’s contribution to increasing access to high-quality diagnostics is an important step forward.