Point-of-care isothermal HPV DNA amplification test for cervical cancer screening in Mozambique

Funding Agency:

Prevent Cancer Foundation

Collaborators:

Rebecca Richards-Kortum (Rice), Kathryn Kundrod (Rice)

Overview:

There is an important need to improve global access to cervical cancer screening. Globally, approximately 570,000 women are diagnosed, and 311,000 women die from cervical cancer each year. Nearly 90 percent of cervical cancer deaths occur in low- and middle-income countries (LMICs), mainly due to challenges in implementing effective screening programs. In Mozambique, the incidence rate is 42.8 and the mortality rate is 35.7 per 100,000 women, and it is estimated that <5% of eligible women have undergone cervical cancer screening. In addition, rates of cervical cancer in medically underserved areas in the U.S. remain high. There is broad consensus that HPV testing is the best approach to improve global screening efforts. However, currently available HPV DNA testing remains too complex and costly for effective implementation into low-resource and medically underserved settings.

Advances in isothermal amplification and paper- and plastic-diagnostic platforms offer an opportunity to develop a point-of-care HPV DNA test that is accurate, affordable, and can be performed in low-resource settings. We have combined isothermal amplification and lateral flow detection within an integrated point-of-care diagnostic device in a format that could dramatically lower the cost and complexity of HPV DNA testing. Our proof-of-concept test will detect HPV types 16 and 18 and we estimate will cost <$5 per test in low-volume production.

Within this project, we aim to complete development and evaluate the clinical feasibility of our point-of-care HPV DNA test. We will initially conduct clinical feasibility testing in the United States, followed by feasibility testing in Mozambique. Our goal in this proposal is to establish equivalent performance and lower cost of our technology relative to existing HPV DNA tests. This research will lead to development and evaluation of a scalable, cost-effective screening test, a critical and necessary step toward global elimination of cervical cancer.