Alaine Umubyeyi, Molbio Diagnostics,
Cervical cancer is the fourth most common cancer in women globally. It caused 662,000 cases and 349,000 deaths in 2022, with 94% of deaths occurring in low- and middle-income countries. With 19 of the top 20 countries worldwide with the highest burden of cervical cancer being in Africa, the continent shoulders a disproportionately high burden of cases. What makes the data even more striking is that all these cases are completely preventable with vaccination and timely screening.
Cervical cancer is caused by human papillomavirus (HPV). While almost all sexually active people are infected with HPV over the course of their lives, the immune system clears the virus naturally in most cases. Persistent infection with a few specific strains of HPV can cause abnormal cells that may develop into cancer. This process typically takes anywhere between 10 to 20 years.
The disease, therefore, has a long pre-cancerous phase, and access to the right screening method at the right time can prevent the progression of infection into cancer.
Traditionally, cervical cancer screening has relied on pap smears and visual inspection with acetic acid. While both these methods have contributed meaningfully to cancer prevention in various parts of the world, HPV DNA-based testing offers a more accurate screening option. Additionally, it identifies risks earlier, even before cellular abnormalities are visible.
Since 2021, WHO has recommended HPV DNA testing as the preferred screening method over visual inspection or cytology in view of these advantages. However, adoption of HPV DNA testing has remained limited because of high costs, laboratory infrastructure requirements, long turnaround times, and challenges in ensuring follow-up.
New evidence published in the International Journal of Cancer could help address some of the longstanding barriers to HPV DNA testing. The study marks the world’s first formal validation of a reduced-valency HPV test. The findings are particularly relevant for Africa, given the epidemiology of cervical cancer in Africa.
The multi-centre study evaluated four Indian point-of-care HPV testing platforms using clinical validation criteria by the International Agency for Research on Cancer (IARC) for reduced-valency HPV assays. While traditionally HPV DNA testing has focused on 14 high-risk strains of HPV, reduced valency assays narrow their target to 7 or 8 strains that are responsible for more than 95% of cervical cancer cases.
Molbio’s 8-valent Truenat HPV-HR Plus was the only test to meet the validation criteria, demonstrating robust clinical performance and higher specificity.
Designed for decentralized settings, the test runs on Molbio’s portable Truenat platform and delivers results in approximately one hour. Importantly, the platform has a significant footprint in African countries due to its ongoing use in infectious disease testing.
Why this matters to Africa
96% of cervical cancer cases worldwide are linked to eight high-risk HPV genotypes – types 16 and 18, which account for approximately 70% of all cases, as well as types 31, 33, 35, 45, 52, and 58.
Among these high-risk strains, HPV35 is associated with only 2% of invasive cervical cancers. But it has a disproportionately higher prevalence in sub‐Saharan Africa, with a recent study estimating 22-30% prevalence among women with invasive cervical cancer lesions in some countries.
Truenat HPV-HR Plus is purpose-built to address this challenge, with HPV35 being one of the eight genotypes the test is capable of detecting.
In August 2020, the World Health Assembly adopted the Global Strategy for Cervical Cancer Elimination. The strategy highlights vaccination, screening, and treatment as the three key pillars for cervical cancer elimination. Specifically, it calls on countries to vaccinate 90% of girls by the age of 15, screen 70% of women by the age of 35, and again by the age of 45; and treat 90% of women with pre-cancer and invasive cancer.
In keeping with these commitments, African countries have made notable progress on HPV vaccination. According to the WHO/UNICEF Estimates of National Immunization Coverage (WUENIC), coverage for at least one dose of the HPV vaccine in the WHO African Region jumped to 40% in 2023, up from just 28% the previous year.
However, a substantial population of adult women remain outside the ambit of vaccination programmes and, therefore, vulnerable to cervical cancer. Reaching this cohort through effective screening programmes will be essential if countries are to achieve WHO’s cervical cancer elimination targets.
The availability of a point-of-care molecular HPV test will enable African countries to decentralize cervical cancer screening to the last mile and enable faster treatment initiation.
The presence of Truenat systems in the countries means they can do this without investing in additional infrastructure, making elimination not a distant dream but an achievable target.