Point-of-care HPV mRNA test for cervical cancer screening in low-resource settings

Funding Agency:

NIH / National Institute of Cancer

Collaborators:

Rebecca Richards-Kortum (Rice), Kathleen Schmeler (UTMDACC), Elizabeth Chiao (UTMDACC), Kristofer Jennings (UTMDACC), Michael Scheurer (Baylor CoM), Jane Montealegre (Baylor CoM)

Overview:

The goal of this project is to combine isothermal amplification and lateral flow detection within an integrated point-of-care device to dramatically lower the cost of hrHPV mRNA testing. We will develop a low-cost, POC hrHPV E7 mRNA test that requires minimal laboratory equipment and performs as well as commercial RNA tests. Isothermal amplification reduces the instrumentation cost and complexity typically associated with nucleic acid amplification requiring only a single-temperature heater. Lateral flow detection integrates sample manipulation processes and wicks all detection reagents past pre-defined test zones, producing a simple, colorimetric readout. Our proposed proof-of-concept test will detect HPV types 16 and 18, the two types responsible for 70% of cervical cancer, and we estimate will cost <$3 per test in low-volume production. Consistent with the exploratory/developmental goals of an R21 proposal, we aim to (1) design and optimize HPV16 and 18 E7 mRNA amplification assays and lateral flow detection; (2) combine mRNA amplification and detection into a single POC device; (3) evaluate performance of the developed mRNA test using synthetic and clinical samples. We will leverage the expertise of our interdisciplinary team, which includes designing technologies for LMICs, cervical cancer care, HPV diagnostics, and epidemiology, to develop, validate, and translate this novel screening test. We intend to build from this proof-of-concept test to incorporate HPV mRNA detection for types 31,33, 35, 45, 52, and 58 in the future to achieve detection of the HPV types that cause >90% of cervical cancer. Collectively, this research will lead to the development and implementation of a scalable, cost effective screening test, a critical and necessary step toward the global elimination of cervical cancer.