Developing molecular diagnostic methods for cervical cancer

The National Cancer Institute awarded the University of Illinois $665,257 on September 3, 2026, under the Cancer Detection and Diagnosis Research program (CFDA 93.394) to develop molecular diagnostic methods for cervical cancer screening.

The recipient will develop and validate a loop-mediated isothermal amplification (LAMP)-based assay for detecting high-risk human papillomavirus (HPV) infection in cervical samples, designed for point-of-care deployment in low-resource settings where access to centralized PCR-based diagnostic laboratories is limited. The project includes comprehensive RNA-sequencing profiling studies to characterize gene expression changes associated with precancerous cervical lesions and to identify molecular biomarkers for triaging HPV-positive cases and gene targets relevant to early cervical cancer development.

Performance is based in Chicago, Illinois, with a period of performance extending from September 3, 2026, through August 31, 2031. This is a Project Grant, a standard NIH R01 assistance type.

Abstract

Cervical cancer is the fourth most common cancer in women worldwide, leading to over 300,000 deaths each year. The death rate of cervical cancer decreased substantially in the US in the twentieth century, mainly due to successful implementation of cervical cancer screening programs based on cervical cytology (PAP test). However, population screening with the PAP test requires extensive clinical expertise and infrastructural setup, which are lacking in low-resource regions. Additionally, PAP testing may not be accessible to women who are unwilling or unable to present to a provider and undergo gynecologic examination for tissue sampling. Over 95% of cervical cancers are caused by human papillomavirus (HPV) infection. Recent studies demonstrate that detection of high-risk HPV cervical infection is a more effective strategy than PAP testing for early screening of cervical cancer. However, most clinically approved methods for HPV diagnosis are based on real-time PCR performed at central diagnostic labs, which may not be widely accessible to the patient population. To address this issue, we propose to develop a robust LAMP-based method for HPV screening. Loop-mediated isothermal amplification (LAMP) is a fast and convenient method to amplify and identify the nucleic acids of a target pathogen. LAMP with colorimetric readout is particularly attractive for point-of-care diagnosis of infectious pathogens including HPV. The main objective of this application is to develop and validate LAMP-based HPV assay with a large patient cohort. Furthermore, we will perform comprehensive RNA-SEQ profiling studies to characterize gene expression changes that are associated with precancerous cervical lesions. In this way, we expect to identify not only molecular biomarkers that could be applied to the triage of HPV-positive cases, but also gene targets that are key to early development of cervical cancer for potential therapeutic intervention.