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Low-cost integrated nucleic acid amplification testing platform for cervical cancer screening in low- and middle-income countries

Award Number: F30CA281115
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: FELLOWSHIP/SCHOLARSHIP/STUDENT LOANS
PERIOD OF PERFORMANCE START DATE: 06/01/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Low-cost integrated nucleic acid amplification testing platform for cervical cancer screening in low- and middle-income countries - PROJECT SUMMARY/ABSTRACT Compared to expensive commercial platforms, point-of-care (POC) strategies have proposed isothermal amplification of DNA as an affordable avenue for testing [1]–[5]; however, there are important gaps to incorporate integrated sample-to-answer platforms that eliminate the risk of workspace contamination and subsequent false positive results. The objective of this project is to develop a low-cost (<$3/test, $500/instrument) fully integrated, quantitative HPV DNA test platform that is simple to use for effective HPV screening at the POC. The Richards-Kortum lab has shown that isothermal amplification with Recombinase Polymerase Amplification can be performed in paper membranes [6]. More recently, the Posner group demonstrated the capability to detect discrete fluorescent amplification nucleation sites using a paper membrane to quantify HIV-1 DNA using a mobile phone-based imager [7]. This proposal builds upon recent advances to design a two-dimensional paper microfluidic device and low-cost imaging platform for detection of high-risk HPV types, HPV16 and HPV18, the primary causes of cervical cancer. This proposal will accomplish these goals by pursuing the following three specific aims: 1) Designing a test to accept and process cervical cytology specimens with pre-loaded lyophilized reagents for amplification of HPV 16/HPV 18 DNA, 2) Developing a low-cost instrument, including a heater and fluorimeter, to monitor multiplexed real-time isothermal nucleic acid amplification reactions, and 3) Conducting a proof-of-principle study to assess usability and efficacy of the test and instrument designed, using banked clinical samples in Houston and Mozambique, Africa. Sensitivity, specificity, and limit of detection analysis will be used to determine comparability to gold standard technologies. Completing these aims will improve cervical cancer screening and reduce morbidity and mortality. This project benefits from comentorship from Dr. Richards-Kortum and Schmeler, who have extensive experience evaluating new technologies for cervical cancer prevention. The training plan and environment have been tailored, focusing on multi-disciplinary, hands-on coursework, lab work, and teaching, and translational research aims with ensure scalability.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $14,514 )
2026	2026	WILLIAM MARSH RICE UNIVERSITY	6100 MAIN ST	HOUSTON	TX	77005	HARRIS	USA	Cancer Research Manpower	000	4	6/19/2026	NON-COMPETING CONTINUATION	$14,514
														Subtotal = $14,514

Issue Date FY: 2025 ( Subtotal = $61,762 )
2025	2025	WILLIAM MARSH RICE UNIVERSITY	6100 MAIN ST	HOUSTON	TX	77005	HARRIS	USA	Cancer Research Manpower	000	3	7/11/2025	NON-COMPETING CONTINUATION	$61,762
														Subtotal = $61,762

Issue Date FY: 2024 ( Subtotal = $53,088 )
2024	2024	WILLIAM MARSH RICE UNIVERSITY	6100 MAIN ST	HOUSTON	TX	77005	HARRIS	USA	Cancer Research Manpower	000	2	5/24/2024	NON-COMPETING CONTINUATION	$53,088
														Subtotal = $53,088

Issue Date FY: 2023 ( Subtotal = $52,694 )
2023	2023	WILLIAM MARSH RICE UNIVERSITY	6100 MAIN ST	HOUSTON	TX	77005	HARRIS	USA	Cancer Research Manpower	001	1	5/19/2023	NEW	$0
2023	2023	WILLIAM MARSH RICE UNIVERSITY	6100 MAIN ST	HOUSTON	TX	77005	HARRIS	USA	Cancer Research Manpower	000	1	5/19/2023	NEW	$52,694
														Subtotal = $52,694

Grand Total All Awards = $182,058

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Low-cost integrated nucleic acid amplification testing platform for cervical cancer screening in low- and middle-income countries

Award Number: F30CA281115

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: FELLOWSHIP/SCHOLARSHIP/STUDENT LOANS

PERIOD OF PERFORMANCE START DATE: 06/01/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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