Supporting exploratory technology projects
Novel and emerging technologies create new opportunities to address clinical needs in low-resource settings. The Center provides financial and technical support to developers of promising technologies to tackle solutions to these identified needs.
Through competitive solicitation processes, the Center identifies, selects, and supports innovative and promising technologies that could have a significant positive impact on public health outcomes. Candidate technologies are assessed for anticipated health impact, relevance to the needs and realities of low-resource settings, and market-related issues that could affect the eventual products’ commercialization prospects.
In the period from 2007 to 2010, the Center announced two competitive peer-reviewed grant opportunities: 1) to fund the development of technologies that support point-of-care molecular diagnostics, and 2) to fund technologies that support HIV viral load testing outside the centralized laboratory setting. The four projects described below have been selected and are currently being funded by the GHDx Center Core 2. Find out more about Center funding opportunities.
Currently funded projects
Development of pDNA Affinity Pairs
Nicolaas M. J. Vermeulen, Epoch Biosciences/EliTech Group, Bothell WA, USA
Epoch Biosciences is developing chemistry which would allow sensitive detection of multiple analytes in a single lateral flow strip. Key to the chemistry is a synthetic nucleic acid, pDNA (pyranosyl-deoxyribose nucleic acid), which does not bind to natural DNA or RNA. An array of 10 pDNA oligomer pairs is being developed which exhibit no cross-reactivity among the 10 pairs.
By creating a chimeric pDNA-DNA primer for PCR amplification, pDNA can be incorporated into the amplicon without interfering with the natural DNA. Its complement can be bound to the lateral flow substrate for capture of the pDNA-containing amplicon. Through multiplexing, several pathogens may be tested simultaneously and detected on the lateral flow strip’s discrete lines. By using colored nanoparticles, visual detection can be used to evaluate results without the need for instrumentation.
Integrated microanalytical extraction-amplification system for detection of tuberculosis in low-resource settings
David Kelso, Principal Investigator, Northwestern University, USA
Mark Nicol, Principal Investigator, University of Cape Town, South Africa
Northwestern University’s Center for Innovation in Global Health Technologies (CIGHT) is developing a closed collection/processing container for nucleic acid amplification testing (NAAT) of Mycobacterium tuberculosis (Mtb) in sputum specimens. The patient would deposit sputum in one compartment of the container which would have a pre-dispensed liquefaction/lysing solution stored in a separate compartment. The test technician would place the container in a small processing unit which would release a lysing solution and sonicate the specimen. An aliquot of the lysed solution would then be transferred to the assay.
Two alternative concepts will be investigated: one based on cold-formed laminated plastic/metal films attached to a rigid plastic frame, the other based on plastic bag technology. They will be evaluated on the basis of assay performance, user feedback, and cost with the goal of producing a simple, affordable, and safe means of preparing specimens for NAAT of Mtb.
Portable low-power nucleic acid extraction module
Catherine Klapperich, Principal Investigator, Boston University, USA
This project focuses on building a no-power device for extracting nucleic acids from patient samples at the point of care. The system consists of a durable extraction device that runs using mechanical pressure, a disposable reagent cartridge, and a sample stabilization "straw." Each patient sample will be extracted and stored on a separate straw, using a different reagent package to eliminate cross contamination. The device is aimed at extracting and stabilizing viral RNA from blood for the purpose of monitoring viral load in HIV positive patients. We expect that RNA stabilized on the straws will not require a cold chain for transport and will outperform currently used blood drop methods.
Low Cost Liat™ Analyzer and HIV Quant Assay
Lingjun Chen, IQuum, Inc., Marlborough, Massachusetts, USA
IQuum is developing a low cost version of the Liat™ HIV Quant Assay and Liat™ Analyzer to enable HIV viral load testing to be performed in low-resource settings. IQuum’s current Liat HIV Quant Assay has reduced viral load testing to a level of simplicity that enables minimally trained operators to reliably perform the test in near-patient settings. The Liat system automates the entire testing process including sample preparation, nucleic acid extraction, PCR amplification, and real-time detection, and outputs interpreted results in less than 1 hour. Third party evaluations have demonstrated that the performance of the Liat assay is highly comparable to that of commercial viral load tests. The goal of this project is to demonstrate the feasibility of developing a low-cost assay and analyzer capable of meeting the performance needs of low-resource settings, and to evaluate the assay in analytical testing.
Photo: PATH/Dimitry Matsyshen.