Improving women’s healthcare in Africa

With the goal of offering innovative diagnostic solutions through its Global Access Program to countries that need it most, Roche is supporting the efforts of healthcare agencies, policymakers and funding institutions to bring rapid, scalable and clinically-validated human papillomavirus (HPV) screening tests for cervical cancer prevention to Kenya and Nigeria.

It is well known that HPV infection is the main cause of cervical cancer, with HPV types 16 and 18 responsible for about 70% of cervical cancer and pre-cancerous cervical lesions.¹ HPV is a quite common sexually transmitted infection and often has no symptoms, meaning women and their partners will not even know they have it. In most cases, an HPV infection will resolve on its own, but in some women, the infection persists, and over time can lead to cervical pre-cancer or cancer. Women in low-income regions are especially vulnerable, because preventive measures to find and treat cervical disease before invasive cancer develops, are not in place. Through proper screening to identify women at risk, HPV immunization strategies and treatment, cervical cancer is one of the few cancers that can be prevented.

With some of the world’s highest incidences of cervical cancer which affects the woman, her family, and entire communities, both Kenya and Nigeria have made a concerted effort to change policies and guidelines, increase awareness among healthcare providers and patients, and implement improved HPV screening and treatment programs.

Cervical cancer is the leading cause of female, gynecologic cancer deaths  in Kenya, with 14.3 million women aged 15 years and above at risk for cervical cancer. The annual number of new cervical cancer cases in the country is 5,250, and the number of cervical cancer deaths is 3,286.²

To help combat the disease, Kenya’s Ministry of Health (MOH) released a set of national cancer screening guidelines, which recommends molecular HPV testing as the primary screening method for cervical cancer for women above 30 years of age.³ If not available, visual inspection with acetic acid (VIA)-based methods can be used.

Kenya also launched a national immunization initiative to provide HPV vaccines free of cost through partnerships with Gavi, UNICEF and the World Health Organization (WHO).^4,5 Furthermore, Kenya instituted in 2020 a national guide on eliminating cervical cancer with the objective to scale up screening, prevention and treatment with sustainable solutions.⁶

In Nigeria, cervical cancer is the second leading cause of female cancer deaths, with 53.1 million women aged 15 years and above at risk for cervical cancer. The annual number of new cervical cancer cases in the country is 14,943, and the number of cervical cancer deaths is 10,403.⁷

Similar to Kenya, Nigeria’s Federal Ministry of Health provided guidance on cervical cancer screening for early detection with the goal of implementing HPV DNA testing as well as VIA.⁸ In 2019, the Nigerian government made a plan for HPV vaccines to be part of the national routine immunization protocol as well as invest in prevention and treatment programs with the objective of controlling and eliminating cervical cancer.⁹ Additionally, Nigeria and WHO are planning a national strategic plan to support cervical cancer interventions, research and training throughout the region.

Many African countries that have high incidences of cervical cancer also report high rates of coinfection with HIV. Women with HIV are six times more at risk of developing cervical cancer.¹⁰ Therefore, it is vital that these regions take the appropriate actions to ensure proper healthcare screening measures are put in place.

With hopes of ramping up better HPV and cervical cancer programs, Kenya and Nigeria are two countries taking the next steps in eliminating cervical cancer.

Cervical screening programs can help decrease the rate of cervical cancer cases and drastically reduce mortality. Visual inspection of the cervix after application of acetic acid (VIA), coupled with subsequent management of abnormalities by cryotherapy, is commonly referred to as “screen and treat,” a strategy that is widely adopted as the standard of care. While this method is considered to be cost-effective in low-income regions, it has many limitations including difficulty in efficiently scaling-up and screening large numbers of individuals.¹¹ Therefore, molecular HPV testing has become the preferred method.¹²

To ensure proper treatment and follow-up, the WHO is urging every country to implement and scale-up HPV screening for women.¹³ In August 2020, WHO adopted a global strategy with the goal of eliminating cervical cancer by 2030 through the implementation of three key target pillars:¹⁴

●  90% of girls fully vaccinated by 15 years of age;

●  70% coverage of screening with a high-performance test once by the age of 35 and again by 45 years;

●  90% of women who are identified with cervical disease receive treatment (90% of women with pre-cancer treated; 90% of women with invasive cancer managed).

In 2019, Unitaid and Clinton Health Access Initiative (CHAI) launched a $33 million project to develop innovative screening tools and introduce new technologies for the detection and treatment of cervical cancer. The 2.5-year project was to begin in seven countries, including Kenya and Nigeria.¹⁵

Roche’s commitment to eliminating cervical cancer

With new recommendations and policies focused on HPV screening now in place at the global and local level, Roche has begun working with Unitaid, CHAI, and UNICEF through the Global Access Program to deliver reliable and clinically-validated molecular HPV diagnostic tests and cervical cancer screening tools to both Kenya and Nigeria.

Roche’s portfolio for cervical cancer prevention enables healthcare professionals to screen, triage and diagnose using a combination of molecular, cellular and tissue-based tests. The portfolio provides a screening strategy that ensures healthcare providers can make informed decisions on patient care and treatment.  It gives countries the opportunity to scale up elimination programs efficiently so that women at risk for cervical cancer can be identified earlier, and more reliably, helping minimize the potential for over- or under-treatment. Many of Roche's diagnostic systems to run the assays used to make critical clinical patient care decisions are established and running in centralized testing labs across Sub-Saharan African countries to support HIV and COVID-19 screening. With these programs already online, Roche’s HPV and cervical cancer screening tests can be easily implemented into the existing infrastructure with minimal effort.

Roche is currently working with the WHO to obtain Prequalification (PQ) Diagnostics Status for its HPV assays on these molecular diagnostic systems for use in resource-limited settings. Both of the HPV assays have been granted the Abridged Assessment Review Path by the WHO. Learn more about the Roche Cervical Cancer Portfolio here.

Continuing Expansion of the Global Access Program

Roche remains committed to helping countries like Kenya and Nigeria eliminate cervical cancer, improving women’s healthcare, decreasing the burden on healthcare systems and promoting a sustainable healthcare infrastructure with high-precision screening solutions.

“In my practice, advanced Cervical Cancer is a very devastating disease to not only women but entire families and communities that we serve here in Africa. Elimination of cervical cancer, therefore, is the single most economic empowerment action that effective partnerships can coalesce in addressing. It is inspiring to note that this is likely to happen in our lifetime!”

-  Professor Fredrick Chite Asirwa MD, Director/CEO-International Cancer Institute (ICI) of Kenya

As the world continues to battle multiple ongoing public health crises, including the COVID-19 pandemic, Roche is making substantial investments in building additional manufacturing capacity to increase production of testing solutions and the instruments on which they are performed. 

Through the Global Access Program, Roche continues to build on its commitment to support customers, communities and patients. Expanding the availability of innovative diagnostic test solutions to countries that need it most is an integral part of Roche's global partnership and collaboration program.