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Highly sensitive isothermal method and instrument for field diagnostics to facilitate malaria eradication

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI129130-01A1
Agency Tracking Number: R41AI129130
Amount: $150,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2019-07-31
Small Business Information
E7279 STATE ROAD 170
Colfax, WI 54730-4728
United States
DUNS: 830768912
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (561) 297-4424
Business Contact
Phone: (715) 505-4123
Research Institution
777 Glades Road
Boca Raton, FL 33431-6424
United States

 Nonprofit college or university

Plasmodium falciparum is the most virulent form of malaria causing million deaths per year Success with
patient treatment and a malaria eradication campaign depends significantly on our ability to detect new
infections as early as possible in the field rural areas including asymptomatic cases preferably using a small
amount of blood e g from a finger prick and to clearly discriminate between current new infection and past
infections Our ultimate goal is to build an inexpensive device that will be fully operational in the field with
minimal training and capable of highly sensitive and selective identification of new malaria infections
We propose a three phase study with the Phase I current proposal focused on identification of the
appropriate molecular targets and the development of a sensitive method of target detection that would
discriminate between current and past infections This project will be performed by Cascade Biosystems
Inc in collaboration with scientists from Florida Atlantic University Muhimbili University of Health and Allied
Sciences Tanzania and Uppsala University Sweden The detection approach is a recently developed
technology that is based on a cascade of enzymatic reactions catalyzed by restriction endonucleases RCEA
restriction cascade exponential amplification RCEA can detect attomolar concentrations of target DNA
comparable in terms of sensitivity to quantitative PCR more importantly it is isothermal and does not require
complex instrumentation or expensive reagents In the Phase I we will adapt RCEA for the diagnostics of malaria
Specific Aims of the Phase I of the proposal are designed to demonstrate a proof of principle the ability of RCEA
approach to detect malaria at high sensitivities comparable to qPCR and to discriminate between current and
past infection Aim Identify appropriate molecular targets for detection of P falciparum infection in
culture using the RCEA approach and compare sensitivity of the RCEA detection to the standard qPCR
approach Parasites growing in culture will be used to simulate and test a wide range of parasite densities
Milestone The RCEA assay developed specifically for detection of malaria targets in l of human blood
comparable to qPCR in terms of sensitivity Aim Determine the potency of the developed RCEA assay for
various gene targets to detect current and past infections in field samples Field samples with various
parasitemia will be tested for diagnosis of malaria using methods established in Aim Various time points
between current and past infection will be simulated using mixtures of samples from untreated and drug treated
patients Milestone the standard operation procedure for detection of current malaria infection by the RCEA
Successful completion of these aims will provide a proof of principle and a strong basis for the Phase II i
development of a fully integrated device based on electrochemical signal detection for field application of the
developed RCEA assay and ii the device testing in the field in malaria endemic areas This in turn will be the
basis for the Phase III focusing on miniaturization and commercialization of the device Project Narrative
This project will adapt a novel and highly sensitive DNA diagnostics technology for early detection of the most
virulent form of malaria caused by Plasmodium falciparum The focus of our project will be to develop a low cost
and field deployable assay for early detection and discrimination between current and past malarial infections
Successful completion will provide a basis to develop a fully integrated small sized hand held device for point
of care applications and for field surveys to facilitate efforts with malaria eradication

* Information listed above is at the time of submission. *

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