The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $354,570 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to Case Western Reserve University (CWRU) for the development of a cost-effective, user-friendly point-of-care (POC) diagnostic tool for HIV and hepatitis B virus (HBV) co-infection. The project aims to create a microchip-based "CamoChip" technology that integrates serological and molecular tests for HIV and HBV into...
This federal Project Grant award, valued at $685,980.00 and issued by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), supports research to isolate broadly protective monoclonal antibodies for Crimean-Congo Hemorrhagic Fever (CCHF). The primary objectives are to: 1) Develop a cohort of CCHF survivors and isolate a panel of monoclonal antibodies against the CCHF virus envelope; 2) Test the efficacy of the...
This federal Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research (CFDA 93.855) program, provides $504,703 to the University of Georgia Research Foundation (UGA Research Foundation) to optimize and fully integrate an "UltraPCR" diagnostic platform for improved detection and assessment of treatment outcomes for Trypanosoma cruzi infection, the causative agent of Chagas disease. The overarching goal...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (CFDA 93.855 - Allergy and Infectious Diseases Research) provides $710,000 to Georgia Southern University Research & Service Foundation Inc. over a 3-year period from June 2025 to May 2028. The project aims to develop comprehensive morphological and molecular tools to accurately identify Hyalomma tick species that are the principal vectors of the Crimean-Congo Hemorrhagic Fever (CCHF) virus. This will...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded Emory University a $2,082,247 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop an economical, rapid molecular diagnostic system for detecting hepatitis C virus (HCV) and HIV from whole blood samples. The research aims to overcome barriers to low-cost implementation of molecular diagnostics for RNA viruses by creating novel chemistries and microfluidics to enable minimally...
The Department of Defense, through the Military Medical Research and Development program (CFDA 12.420), awarded a $1,857,470 Cooperative Agreement to The Geneva Foundation to develop a multiplex testing platform that can simultaneously detect and identify Plasmodium species infections. This platform will serve as both a diagnostic tool and an epidemiological surveillance tool. The project performance period is from June 1, 2024 to May 31, 2028. Under a $268,312 sub-award, Meso Scale...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $1,144,171 to the Albert Einstein College of Medicine to conduct research on the Crimean-Congo Hemorrhagic Fever Virus (CCHFV). The overarching goal is to address critical gaps in understanding the structure, assembly, and functions of the CCHFV glycoprotein complex, which plays a key role in virus entry, assembly, and...
This Project Grant award of $3,055,197.00 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) supports the development and evaluation of a rapid, low-cost phenotypic test for the detection of carbapenemase-producing organisms (CPOs). The objective is to create a structurally-programmed sticker microfluidic test that can provide rapid, objective carbapenemase detection and distinguish between carbapenemase...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), will support the development of a novel universal rapid test for HIV diagnosis. IGE Immunodiagnostics & Therapeutics, LLC, a minority-owned small business, will receive $294,948 to adapt their existing HIV ELISA test into a 5th generation antigen/antibody combination rapid test format. The goal is to create a simple, rapid,...
This $537,619 Project Grant awarded by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) supports the development of a novel electrochemical biosensor technology capable of simultaneously detecting HIV, hepatitis B, and hepatitis C viruses. The project aims to integrate the recently developed four-way junction (4WJ) electrochemical biosensor with an isothermal nucleic acid amplification technique to create a...
PANDAA FOR UNIVERSAL, PAN-LINEAGE MOLECULAR DETECTION OF CRIMEAN-CONGO HEMORRHAGIC FEVER VIRUS - CRIMEAN-CONGO HEMORRHAGIC FEVER (CCHF) IS A TICK-BORNE DISEASE WITH HIGH MORTALITY RATES IN HUMANS AND HIGH OUTBREAK POTENTIAL. FOUND IN 30 COUNTRIES ACROSS EUROPE, ASIA, AND AFRICA, CCHF HAS AN EXTREMELY WIDESPREAD AND GROWING RANGE. ITS CAUSATIVE AGENT, CCHF VIRUS (CCHFV), IS LISTED AMONG THE URGENTLY CONCERNING PATHOGENS PRIORITIZED IN THE WHO R & D BLUEPRINT. WITH AT LEAST SEVEN REGIONAL CLADES, CCHFV DETECTION BY GOLD STANDARD QPCR- BASED METHODS HAS BEEN ENCUMBERED BY SIGNIFICANT STRAIN-ASSOCIATED GENETIC VARIABILITY. EXISTING TESTS FOR CCHFV ARE OFTEN LIMITED TO REGIONAL USE, PRESENTING A BARRIER TO STANDARDIZATION AND QUALITY ASSURANCE. THE WHO HAS CALLED FOR THE DEVELOPMENT OF UNIVERSAL CCHFV DIAGNOSTICS AS A GLOBAL PRIORITY. ALDATU BIOSCIENCES HAS PIONEERED THE USE OF PANDAA TECHNOLOGY, WHICH ENABLES PROBE-BASED QPCR FOR TARGET DETECTION IN HIGHLY VARIABLE GENOMIC REGIONS BY SIMULTANEOUSLY ADAPTING AND AMPLIFYING DIVERSE TEMPLATES. PANDAA UNIQUELY MITIGATES THE PRESENCE OF TARGET- PROXIMAL POLYMORPHISMS TO ALLOW OTHERWISE DIVERGENT TEMPLATES TO BE DETECTED WITH CONSENSUS FLUORESCENT PROBES WITH SIMILAR SENSITIVITIES. AS SUCH, PANDAA-ENABLED QPCR IS AN IDEAL SOLUTION FOR UNIVERSAL DETECTION OF PATHOGENS WITH SIGNIFICANT STRAIN, LINEAGE, AND/OR SUB-TYPE SEQUENCE DIVERSITY. ALDATU BIOSCIENCES IS UNIQUELY POSITIONED TO DELIVER A RAPID PAN-LINEAGE QPCR-BASED CCHFV DIAGNOSTIC. PANDAA HAS BEEN SUCCESSFULLY APPLIED TO SUBTYPE- INDEPENDENT DETECTION OF MORE THAN FIFTEEN DRUG RESISTANCE MUTATION (DRM) TARGETS IN HIV. RECENTLY, WE COMPLETED DEVELOPMENT OF THE FIRST PAN-LINEAGE ASSAY FOR LASSA FEVER VIRUS (LASV), ANOTHER WHO PRIORITY PATHOGEN WITH HIGH OUTBREAK POTENTIAL. WE PROPOSE TO LEVERAGE THE UNIQUE CAPABILITIES OF PANDAA TO DEVELOP A RAPID, SENSITIVE MOLECULAR DIAGNOSTIC ASSAY FOR CCHFV DETECTION, AND THE FIRST WITH PAN-LINEAGE COVERAGE, THROUGH THE FOLLOWING SPECIFIC AIMS: (1) DEVELOPMENT OF A PAN-LINEAGE PANDAA-CCHFV ASSAY, LEVERAGING PROVEN TECHNIQUES AND PROPRIETARY PANDAA REAGENT DESIGN; (2) ANALYTICAL VALIDATION OF THE PANDAA-CCHFV ASSAY, INCLUDING CONFIRMATION OF CLADE INCLUSIVITY AND HIGH SPECIFICITY; (3) THERMOSTABILIZATION OF THE PANDAA-CCHFV ASSAY, IN ORDER TO MEET THE REQUIREMENTS OF DIAGNOSTICS TARGETED TO LMICS; (4) CLINICAL VALIDATION OF THE LYOPHILIZED PANDAA-CCHFV ASSAY, USING CLINICAL SAMPLES REPRESENTING A BROAD VARIETY OF CIRCULATING CLADES AND GEOGRAPHIES; AND (5) MULTI-SITE EVALUATION OF THE PANDAA QDX CCHFV TEST KIT AT REFERENCE LABS AT CDC- AND WHO-AFFILIATED PARTNER INSTITUTIONS. AS THE FIRST PAN- LINEAGE ASSAY, PANDAA-CCHFV WILL PROVIDE A RAPID, STANDARDIZED TESTING OPTION FOR ALL REGIONS WITHIN THE BROAD RANGE OF CCHFV. THIS NOVEL, PAN-LINEAGE DETECTION ASSAY COULD ULTIMATELY BE DEPLOYED IN ANY ENDEMIC REGION ON PRE-EXISTING QPCR EQUIPMENT IN CENTRAL LABS, AND/OR INTEGRATED INTO A CLOSED, POINT-OF-CARE SYSTEM WITH SAMPLE PROCESSING TO RADICALLY IMPROVE THE CCHFV DIAGNOSTIC WORKFLOW.