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The first commercial rapid diagnostic test to detect Paragonimus infections

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI147875-01
Agency Tracking Number: R41AI147875
Amount: $238,810.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-08-01
Award End Date (Contract End Date): 2020-04-30
Small Business Information
San Diego, CA 92111-1806
United States
DUNS: 159070825
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 349-5094
Business Contact
Phone: (858) 565-4227
Research Institution
SAINT LOUIS, MO 63130-4862
United States

 Nonprofit College or University

Abstract We propose an ultrasensitive rapid diagnostic testRDTto detect exposure to pulmonary flukes of the genus ParagonimusParagonimiasis affects an estimatedmi l l ion people and remains amongst the most neglected of all neglected tropical diseasesNTDsThis trematode is acquired upon ingestion of raw or undercooked freshwater crustaceans and migrates to the lungs where it forms cystsTreatment is straightforwardpraziquantelbut diagnosis is notThe classical methoddetection of Paragonimus eggs in sputum or stoolrequires rarely available microscopy expertiseis slow throughputand is limited to egg producing adult flukesWith an effective drug at hand but no convenient diagnostica highly sensitive RDT is the missing piece to enable efficient clinical management of paragonimiasisA paragonimiasis RDT is all the more needed when considering that many paragonimiasis symptoms resemble those of TB or lung cancerincluding hemoptysisblood in sputumpersistent coughweight lossand cysts in CT scansMisdiagnosis is common and patients are incorrectly put on ineffective antibiotic regimens or toxic cancer chemotherapywith serious consequencesThis project combines two innovationsathe re ce nt di scovery of novel paragonimiasis bi omarkers by re searchers at Washi ngton Uni versi tywho identified a list ofimmunoreactive Paragonimus proteinsThe two most promising antigens are myoglobinand cysteine proteaseCPOn the basis of Western blots obtained with a small set of seraantibodies to myoglobintotal IgGand CPIgGsubtypedetect paragonimiasis withsensitivity andspecificitywhen using other trematode and nematode infections as comparatorsbwe have developed goldnanoshellsa novel plasmonic nanoparticle designed to increase the analytical sensitivity of RDTsand applied them to overdifferent analytesWe have expertise with detecting IgG and IgGresponses through our work on other helminth proteinsloa loa SXPloiasisWuchereria bancrofti Wblymphatic filariasisand Onchocerca volvulus Ovriver blindnessThe human benefit of our RDT will be significantathis will be the first commercial assay for paragonimiasisbthe RDT will further assist the differential diagnosis of tuberculosislung cancerand other pulmonary diseasescwhile high prevalence areas in Asia stand to benefit most from a new testthe assay would also be useful in the USAdespite low infection ratesas witnessed by the CDC s interest in this project Project Narrative Flukes of the genusParagonimusare food borne parasites that migrate from the intestine to the lungswhere they cause clinical signs similar to those of tuberculosis and lung cancerblood in sputumchronic coughweight losscysts in X rayetcDespite an estimatedmillion people infectedmostly in Asiathere are no convenient commercial diagnostics to detect this diseaseHere we propose the first commercial rapid diagnostic test to detect Paragonimus infectionsa disease that can be easily cured if diagnosed properly

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

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