Sample-to-answer HPV DNA nucleic acid test for cervical cancer screening in Mozambique
Project Number1U01CA292741-01
Contact PI/Project LeaderRICHARDS-KORTUM, REBECCA R. Other PIs
Awardee OrganizationRICE UNIVERSITY
Description
Abstract Text
PROJECT SUMMARY / ABSTRACT
Cervical cancer is the 4th most common female cancer and cause of cancer-related mortality worldwide, despite
being preventable through HPV (human papillomavirus) vaccination and early detection and treatment of
precancerous lesions. In high-income countries, cervical cancer incidence and mortality rates have been reduced
through HPV vaccination and screening based on cytology and HPV testing. However, in low- and middle-income
countries, especially in sub-Saharan Africa, the burden of cervical cancer remains high due to a lack of effective
programs for vaccination and screening. While the World Health Organization (WHO) recommends cervical
cancer screening using a nucleic acid test to detect high-risk HPV DNA, most low- and middle-income countries
have difficulty implementing HPV testing due to the high cost of tests, the need for lab infrastructure and trained
personnel, and long sample-to-answer times. There is an urgent need for novel, low-cost, accurate, and
accessible approaches to improve screening.
The goal of this project is to develop a point-of-care HPV DNA test that meets WHO goals for cervical cancer
screening in low- and middle-income countries by adapting and integrating two innovations: 1) an extraction-
free, multiplexed, isothermal nucleic acid amplification assay; and 2) a fully integrated nucleic acid amplification
and lateral flow detection platform called NATFlow. The resulting NATFlow HPV test will be affordable, rapid,
and simple to use at the point-of-care. We aim to: 1) adapt existing extraction-free, multiplexed, sample-to-
answer Loop-Mediated Isothermal Amplification (LAMP) assays to detect eight high risk types of HPV on the
NATFlow platform and demonstrate technical functionality with 140 provider-collected clinical specimens; (2)
evaluate clinical performance of the NATFlow HPV test in Mozambique, first in 558 banked preserved samples
and then prospectively in 1,890 women undergoing cervical cancer screening at Hospital Central de Maputo and
surrounding community clinics; and (3) evaluate barriers/facilitators to cervical cancer screening using the
NATFlow HPV test in Mozambique.
We have assembled an interdisciplinary team based in the US, Mozambique, and Australia with extensive
collective experience in developing, evaluating, commercializing, and scaling new technologies to prevent
cervical cancer. We have a strong record of carrying out translational and implementation research in low- and
middle-income countries including Mozambique. Our industrial team has expertise in developing and translating
well-designed instrumentation and chemistries for point-of-care tests. Our team is ideally suited to adapt,
validate, and prepare to scale the NATFlow HPV test to accelerate global efforts to prevent cervical cancer.
Public Health Relevance Statement
PROJECT NARRATIVE
There is an urgent need to develop low-cost, accurate and accessible approaches to improve cervical cancer
screening in low- and middle-income countries, which bear the greatest burden of disease. We will adapt
advances in nucleic acid amplification technology developed for COVID surveillance to develop the NATFlow
HPV assay, a low-cost, fully integrated, sample-to-answer nucleic acid test that meets the needs for cervical
cancer screening in low-resource settings. We will use a community- and stakeholder-engaged process to
evaluate the technical and clinical performance of the NATFlow HPV test in Mozambique, as well as barriers
and facilitators to its future implementation, in Mozambique.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AccelerationAcetic AcidsAddressAdoptionAfrica South of the SaharaAgeAustraliaBiological AssayCOVID-19 assayCOVID-19 surveillanceCancer EtiologyCaringCell LineCervicalCervical Cancer ScreeningCessation of lifeChemistryClinicalCommunitiesCountryCytologyDNADNA amplificationDeath RateDetectionDevicesDiagnosisDiseaseDisparityEarly DiagnosisEarly treatmentEligibility DeterminationEnrollmentEquipmentFemaleGeneral PopulationGoalsHIVHPV screeningHPV-High RiskHealthHospitalsHourHuman Papilloma Virus VaccinationHuman Papilloma Virus VaccineHuman PapillomavirusHuman ResourcesImmunization ProgramsImprove AccessIncidenceIncomeIndustrializationInfrastructureLateralLesionMalignant NeoplasmsMalignant neoplasm of cervix uteriMediatingMethodsMozambiqueNew EnglandNucleic Acid Amplification TestsNucleic AcidsOrganizational ObjectivesPerformancePreparationProcessProviderQualifyingRecommendationReportingResource-limited settingRiceRiskSamplingSensitivity and SpecificitySpecimenTechnologyTemperatureTestingTimeTrainingTraining and InfrastructureTranslatingTranslational ResearchVaccinationVisualWomanWorkWorld Health Organizationamplification detectionburden of illnesscarcinogenicitycervical cancer preventioncommercializationcommunity cliniccommunity partnerscontextual factorscostdesigndetection limitdetection platformexperiencefuture implementationgirlshigh riskimplementation researchimprovedinnovationinstrumentinstrumentationisothermal amplificationlateral flow assaylow and middle-income countrieslow income countrymanufacturemedical specialtiesmortalitynew technologynovelnucleic acid detectionperformance testspoint of carepoint of care testingpremalignantpreservationpreventprogramsprospectivescreeningtoolusabilitywomen's diagnosis
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