Target product profiles for human papillomavirus screening tests to detect cervical pre-cancer and cancer
Author: World Health Organization
Publisher: World Health Organization
Published: 2024-09-30
Total Pages: 72
ISBN-13: 924010027X
DOWNLOAD EBOOKIn 2021 WHO released updated guidelines on cervical screening and treatment, prioritizing the use of HPV testing in primary screening, both for the general female population and for women living with HIV. Although there are more than 250 HPV tests commercially available, governments and other stakeholders are facing multiple challenges to implement HPV-based cervical screening, starting with the limited availability of validated, affordable, high-performance HPV tests. WHO TPPs aim to incentivize the development of health products that are fit for purpose. This entails keeping the focus on public health priorities, and recognizing that access, equity and affordability are integral parts of the innovation process that need to be considered from the early research and development stages. As the rate of return on global health products tends to be lower than for products targeting markets in high-income countries only, the TPPs are also an indication of need and future policy developments, and therefore purchasing. As such, they aim to contribute to reducing investment risk and increasing the likelihood that novel tests will be developed that meet the needs identified by WHO. WHO prioritized the development of TPPs for HPV testing that will guide innovation and motivate test developers and manufacturers to address global health needs and contribute to countries’ efforts to reach their 2030 target of 70% cervical cancer screening coverage.