The Challenge

Cervical Cancer Screening for Low-resource Areas

Worldwide, cervical cancer is the second-leading cause of cancer death in women, but it can be treated effectively if caught at an early stage. In developed countries like the United States, screening methods like the Pap smear can detect early cancer signs but require advanced infrastructure, like well-equipped laboratories and trained pathologists, that is unavailable in many remote and less-developed regions. This leads to a dramatic gap in patient outcomes: approximately 90% of cervical cancer deaths occur in low and middle-income countries (WHO). In sub-Saharan Africa, this disease is the number one cause of cancer death in women.

Current methods for cervical cancer screening in low-resource areas lack combined specificity and sensitivity. Human Papilloma Virus (HPV), the virus that can lead to cervical cancer, is a popular target for the development of new point-of-care tests, but cannot identify cancerous cells or whether the patient needs treatment, since a patient with HPV will not necessarily develop cancer. Other screening methods involve visual inspection with stains applied to the cervix that cause precancerous and cancerous lesions to change color. Visual inspection can indicate areas of afflicted tissue, but are not very specific and can lead to overtreatment, causing unnecessary future complications with pregnancy and menstrual health.

A point-of-care screening method that is highly sensitive and specific to early-stage cervical cancer could substantially reduce patient mortality in areas that lack access to well-equipped hospitals and laboratories. In addition to being accurate, it is vital that a new test would be user-friendly and able to provide results to patients within the duration of a single visit to a local or traveling clinic.

The Purdue Innovation: A Paper Test Strip for Accurate, Point-of-Care Cervical Cancer Detection

A paper test strip that detects early-stage cervical cancer will make disease identification fast, easy, and accurate. The test strip will work by identifying a protein in cervical cells that indicates early and later stages of cervical cancer. With this test strip, healthcare providers will be able to verify within a single visit whether a patient needs treatment, drastically reducing cost to both patient and provider, eliminating the need for multiple visits and subsequent loss to follow-up, and reducing complications from unnecessary treatment.

Deliverables

• A paper test strip that will identify a cancer-indicating protein in laboratory cultured cervical cancer cells
• A platform for multiplex testing of cervical samples
• Preliminary feasibility and acceptability evaluation in Eldoret, Kenya

Dr. Jacqueline Linnes, Dr. Sulma Mohammed and their team are working at Purdue to develop the paper test strip in the lab and validate it using clinical specimens from patients in the United States. Once validated, test strip prototypes will be tested in a cross-sectional clinical validation study conducted in collaboration with the University of North Carolina’s Division of Global Women’s Health (UNC GWH) and the Cervical Cancer Prevention Program in Zambia (CCPPZ), Since 2006, CCPPZ has provided cervical screening services to over 350,000 women, and the results of this study will inform future integration of this protein-based, point-of-care screening test into cervical cancer prevention programs in Zambia.

The Partners:

Purdue University:

• Jacqueline Linnes, Ph.D., Weldon School of Biomedical Engineering
• Sulma Mohammed, Ph.D., Department of Comparative Pathobiology
• Emilie Newsham, Graduate Research Assistant

AMPATH: Kirtika Patel, MD, Head of Immunology