SBIR-STTR Award

Facile Detection of Soil-Transmitted Helminth Infections
Award last edited on: 5/3/2016

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$597,265
Award Phase
2
Solicitation Topic Code
855
Principal Investigator
Michael J C Crawford

Company Information

Divergence Inc (AKA: Divergence LLC)

1005 North Warson Road
St Louis, MO 63132
   (314) 694-9900
   info@divergence.com
   www.divergence.com
Location: Single
Congr. District: 01
County: St. Louis

Phase I

Contract Number: 1R43AI085744-01A1
Start Date: 7/15/2010    Completed: 6/30/2012
Phase I year
2010
Phase I Amount
$173,139
The goal of this project is to develop a rapid and accurate immunodiagnostic test for detection of soil- transmitted helminths (STHs) that can be used without laboratory infrastructure. Human STH infections from whipworm (Trichuris), roundworm (Ascaris), and hookworms (Necator and Ancylostoma) create a substantial burden to worldwide public health. Current infection rates are staggering, with well over one billion people estimated to be harboring at least one of these nematode parasites, causing substantial morbidity. The current global strategy to control STH infections involves mass drug administration (MDA) of anthelmintic medicines without prior diagnosis. However, cure is often not complete and the limited number of available drugs has fueled concerns of parasite resistance. To support this drug administration strategy, clinical research activities have concurrently intensified. These include monitoring for the emergence of drug resistance and the effects of worm infection on childhood growth and development. Despite these needs, no commercial product to detect these parasites is available. All current diagnostic methods require the use of laboratory equipment and clinically trained personnel to identify parasitic species. The most widely-used method is the microscopic detection of parasite eggs, a labor-intensive technique with inadequate sensitivity and specificity. Therefore a rapid, sensitive, specific, and inexpensive method to detect parasitic worm infections without laboratory infrastructure or trained personnel would offer enormous advantages over current methods. Building upon extensive proof-of-concept data with closely related parasites, this proposal aims to develop an immunodiagnostic assay for detection of human STHs. The first step toward feasibility will involve cloning, recombinant expression, and generation of antiserum to select helminth targets, followed by ELISA and western analyses with parasite extracts and clinical samples (Phase I). Once targets providing adequate sensitivity and specificity are validated, further assay optimization, expansion of reagents, and evaluation of multiple epidemiologic settings will commence (Phase II).

Public Health Relevance:
Soil-transmitted helminths (STHs, roundworms) currently infect over one billion people globally, causing substantial morbidity and economic loss. The current microscopic method for detecting these parasites is time-consuming, requires laboratory infrastructure, and suffers from poor sensitivity. The goal of this project is to develop a rapid and accurate immunodiagnostic test for STH infections in support of patient management, epidemiologic studies, and surveillance of mass drug administration programs.

Thesaurus Terms:
"0-11 Years Old; 21+ Years Old; Aids Virus; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Adult; Advocate; Ancylostoma; Ancylostoma (Genus); Ancylostomatidae; Animals; Anthelmintics; Antibodies; Antigen Targeting; Antihelminthic Agent; Antihelminthic Drugs; Antisera; Area; Armed Forces Personnel; Articulation; Arts; Ascaris; Assay; Bedside Testings; Bioassay; Biologic Assays; Biological Assay; Biological Symbiosis; Brazil; Child; Child Youth; Childhood; Children (0-21); Clinical; Clinical Research; Clinical Study; Cloning; Cognitive; Collaborations; Communities; Country; Data; Detection; Development; Diagnosis; Diagnosis, Immunological; Diagnostic; Diagnostic Method; Diagnostic Procedure; Diagnostic Technique; Disease; Disorder; Drug Resistance; Drugs; Elisa; East Indies; Economics; Electricity; Endemic Diseases; Enzyme-Linked Immunosorbent Assay; Epidemiologic Research; Epidemiologic Studies; Epidemiological Studies; Epidemiology; Epidemiology Research; Equipment; Evaluation; Field Workers; Fieldworker; Foundations; Generalized Growth; Generations; Genomics; Goals; Growth; Growth And Development; Growth And Development Function; Hiv; Hosp; Htlv-Iii; Health; Helminths; Hookworms; Hospitals; Human; Human Immunodeficiency Viruses; Human Resources; Human T-Cell Leukemia Virus Type Iii; Human T-Cell Lymphotropic Virus Type Iii; Human T-Lymphotropic Virus Type Iii; Human, Adult; Human, Child; Human, General; Immigrant; Immune Sera; Immunoblotting; Immunodiagnoses; Immunodiagnosis; Immunodiagnostics; Immunologic Diagnosis; Immunological Diagnosis; India; Indonesia; Infection; Infrastructure; Institutes; Intestinal; Intestines; Joints; Lav-Htlv-Iii; Laboratories; Lateral; Legal Patent; Lymphadenopathy-Associated Virus; Malaria; Malay Archipelago; Malnutrition; Man (Taxonomy); Man, Modern; Manpower; Medication; Medicine; Methods; Methods And Techniques; Methods, Other; Metric; Microscope; Microscopic; Military; Military Personnel; Monitor; Morbidity; Morbidity - Disease Rate; Necator; Nematoda; Nematodes; Netherlands East Indies; Nutritional Deficiency; Oral Poliovirus Vaccine; Ortholog; Orthologous Gene; Paludism; Parasite Resistance; Parasites; Patents; Patients; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Physicians; Plasmodium Infections; Poliovirus Vaccine, Oral; Poverty; Predisposition; Preparation; Programs (Pt); Programs [publication Type]; Public Health; Quantitative Evaluations; Reagent; Recombinants; Refugees; Research; Research Activity; Research Infrastructure; Research Specimen; Rural; Sabin Vaccine; Sampling; Science Of Medicine; Sensitivity And Specificity; Soil; Specificity; Specimen; Susceptibility; Techniques; Technology; Test Result; Testing; Testings, Bedside; Therapeutic Uses; Time; Tissue Growth; Training; Transmission; Trichocephalus; Trichuris; Tuberculosis; Undernutrition; Universities; Vaccines; Vermifuges; Virus-Hiv; Washington; Worms, Parasitic; Adult Human (21+); Bowel; Burden Of Disease; Burden Of Illness; Children; Commercialization; Companion Animal; Dietary Deficiency; Disease Burden; Disease Control; Disease/Disorder; Disorder Control; Disseminated Tb; Disseminated Tuberculosis; Drug Resistant; Drug/Agent; Egg; Human Disease; Innovate; Innovation; Innovative; Interest; Neglect; Ontogeny; Parasite Resistant; Parasitism; Pediatric; Personnel; Point Of Care; Point Of Care Testing; Product Development; Programs; Public Health Medicine (Field); Public Health Relevance; Reagent Testing; Resistance To Drug; Resistance To Parasite; Resistant To Drug; Resistant To Parasite; Roundworm; Rural Area; Transmission Process; Tuberculous Spondyloarthropathy; Years Of Life Lost To Disability; Years Of Life Lost To Disease; Youngster"

Phase II

Contract Number: 6R43AI085744-02
Start Date: 2/22/2011    Completed: 6/30/2012
Phase II year
2010
(last award dollars: 2011)
Phase II Amount
$424,126

The goal of this project is to develop a rapid and accurate immunodiagnostic test for detection of soil- transmitted helminths (STHs) that can be used without laboratory infrastructure. Human STH infections from whipworm (Trichuris), roundworm (Ascaris), and hookworms (Necator and Ancylostoma) create a substantial burden to worldwide public health. Current infection rates are staggering, with well over one billion people estimated to be harboring at least one of these nematode parasites, causing substantial morbidity. The current global strategy to control STH infections involves mass drug administration (MDA) of anthelmintic medicines without prior diagnosis. However, cure is often not complete and the limited number of available drugs has fueled concerns of parasite resistance. To support this drug administration strategy, clinical research activities have concurrently intensified. These include monitoring for the emergence of drug resistance and the effects of worm infection on childhood growth and development. Despite these needs, no commercial product to detect these parasites is available. All current diagnostic methods require the use of laboratory equipment and clinically trained personnel to identify parasitic species. The most widely-used method is the microscopic detection of parasite eggs, a labor-intensive technique with inadequate sensitivity and specificity. Therefore a rapid, sensitive, specific, and inexpensive method to detect parasitic worm infections without laboratory infrastructure or trained personnel would offer enormous advantages over current methods. Building upon extensive proof-of-concept data with closely related parasites, this proposal aims to develop an immunodiagnostic assay for detection of human STHs. The first step toward feasibility will involve cloning, recombinant expression, and generation of antiserum to select helminth targets, followed by ELISA and western analyses with parasite extracts and clinical samples (Phase I). Once targets providing adequate sensitivity and specificity are validated, further assay optimization, expansion of reagents, and evaluation of multiple epidemiologic settings will commence (Phase II).

Public Health Relevance:
Soil-transmitted helminths (STHs, roundworms) currently infect over one billion people globally, causing substantial morbidity and economic loss. The current microscopic method for detecting these parasites is time-consuming, requires laboratory infrastructure, and suffers from poor sensitivity. The goal of this project is to develop a rapid and accurate immunodiagnostic test for STH infections in support of patient management, epidemiologic studies, and surveillance of mass drug administration programs.

Public Health Relevance Statement:
7. Project Narrative Soil-transmitted helminths (STHs, roundworms) currently infect over one billion people globally, causing substantial morbidity and economic loss. The current microscopic method for detecting these parasites is time-consuming, requires laboratory infrastructure, and suffers from poor sensitivity. The goal of this project is to develop a rapid and accurate immunodiagnostic test for STH infections in support of patient management, epidemiologic studies, and surveillance of mass drug administration programs.

Project Terms:
No Project Terms available.