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Principal Investigator: Michael Hannan
Organization: PEARL DIAGNOSTICS, INC.
Fiscal Year: 2021
Award: $976,576
Funding agency: National Institute of Allergy and Infectious Diseases
Aspergillosis causes morbidity and death in medically immune compromised patients,
especially after cancer chemotherapy and transplant. Recently, we have witnessed
increased cases of influenza-associated aspergillosis and COVID-19-associated
aspergillosis, complicating effective treatment in those critically ill with viral infections.
Outcomes are poor in part because we lack sensitive diagnostic tests that are easy to
use during high-risk periods. During our efforts to develop easier diagnostic tests, we
discovered that fungal galactofuranose (galf)– containing antigens are excreted in urine
of infected animals and people, using novel monoclonal antibodies. We engineered a
prototype enzyme immunoassay called MycoMEIA, and performance was tested using
urine samples obtained from patients with suspected and confirmed IA. Results showed
>80% sensitivity and specificity, meeting predefined metrics for clinical study. As part of
this proposal, this design-locked assay will move into clinical study, in three clinical
microbiology laboratories to support FDA 510k application. Additional work is proposed to
understand how the urine assay can be optimized to detect aspergillosis in non-hematology
patients at risk, including ICU patients with COVID-19. Success in meeting the milestones
described will lead to commercial availability of the first rapid, easy to use urine diagnostic
assay for this important fungal infection, with potential to reduce disease prevalence and
improve outcomes.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><Agreement><Airway Disease><Animals><Antibodies><Antifungal Agents><Antifungal Drug><Antigenic Determinants><Antigens><Aspergillosis><Aspergillus><Assay><Attention><Award><Binding Determinants><Bioassay><Biologic Assays><Biological Assay><Biological Markers><Blood Serum><CLIA accredited><CLIA approved><CLIA certified><CLIA compliant><CLIA licensed><COVID infected patient><COVID patient><COVID positive patient><COVID-19><COVID-19 infected patient><COVID-19 patient><COVID-19 positive patient><COVID-19 virus><COVID19><COVID19 patient><COVID19 positive patient><COVID19 virus><CV-19><CV19><Cancer Cause><Cancer Etiology><Cancers><Cessation of life><Characteristics><Chemotherapy Protocol><Chemotherapy Regimen><Chemotherapy, Cancer, General><Chemotherapy-Oncologic Procedure><Clinical><Clinical Microbiology><Clinical Research><Clinical Study><Clinical Treatment Moab><CoV-2><CoV2><Collection><Combination Chemotherapy Regimen><Consent><Critical Illness><Critically Ill><Death><Development><Development and Research><Diagnosis><Diagnostic><Diagnostic tests><Disease><Disorder><Drugs><Early Diagnosis><Engineering><Environment><Enzyme Immunoassay><Enzyme Linked Immunoassay Immunologic><Epitopes><Ferroprotoporphyrin><Freezing><Fungal Antigens><Fungal Spores><Fungus Diseases><Glycans><Gold><Grippe><Hematologic Cancer><Hematologic Malignancies><Hematologic Neoplasms><Hematological Malignancies><Hematological Neoplasms><Hematological Tumor><Hematology><Hematopoietic Cancer><Heme><Immune><Immune system><Immunes><Infection><Infection prevention><Influenza><Inhalation><Inhaling><Knowledge><Laboratories><Legal patent><Lung><Lung Grafting><Lung Respiratory System><Lung Transplantation><Lung diseases><Malignant Hematologic Neoplasm><Malignant Neoplasms><Malignant Tumor><Maryland><Medical><Medication><Methods><Molecular Weight><Monoclonal Antibodies><Morbidity><Morbidity - disease rate><Mycoses><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Organism><Outcome><Patents><Patients><Performance><Pharmaceutic Preparations><Pharmaceutical Preparations><Phase><Pneumonia><Polysaccharides><Prevalence><Prevent infection><Protocol><Protocols documentation><Protoheme><Publishing><Pulmonary Diseases><Pulmonary Disorder><Quimioterapia><R & D><R&D><Recovery><Reproducibility><Research><Respiratory Disease><Respiratory System Disease><Respiratory System Disorder><Risk><SARS corona virus 2><SARS-CoV-2><SARS-CoV-2 infected patient><SARS-CoV-2 patient><SARS-CoV-2 positive patient><SARS-CoV2><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><SBIR><Sampling><Sensitivity and Specificity><Serum><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><Site><Small Business Innovation Research><Small Business Innovation Research Grant><Specificity><Technology><Technology Transfer><Testing><Therapeutic Fungicides><Time><Tracheobronchial><Transplant Recipients><United States National Institutes of Health><Urine><Urine Urinary System><Viral Diseases><Virus Diseases><Work><Wuhan coronavirus><allergic/immunologic body system><allergic/immunologic organ system><anti-fungal><anti-fungal agents><anti-fungal drug><antifungals><base><bio-markers><biologic marker><biomarker><cancer chemotherapy><cancer transplantation><corona virus disease 2019><coronavirus disease 2019><coronavirus disease 2019 infected patient><coronavirus disease 2019 patient><coronavirus disease 2019 positive patient><coronavirus disease 2019 virus><coronavirus disease infected patient><coronavirus disease patient><coronavirus disease positive patient><coronavirus patient><depository><design><designing><developmental><diagnostic assay><disease of the lung><disorder of the lung><drug/agent><early detection><effective therapy><effective treatment><extracellular vesicles><ferroheme><fungal infection><fungal pneumonia><fungus><fungus infection><galactomannan><hCoV19><high risk><immunogen><improved outcome><living system><lung disorder><lung transplant><mAbs><malignancy><meetings><nCoV2><neoplasm/cancer><novel><patient infected with COVID><patient infected with COVID-19><patient infected with SARS-CoV-2><patient infected with coronavirus disease><patient infected with coronavirus disease 2019><patient infected with severe acute respiratory syndrome coronavirus 2><patient with COVID><patient with COVID-19><patient with COVID19><patient with SARS-CoV-2><patient with coronavirus disease><patient with coronavirus disease 2019><patient with severe acute respiratory distress syndrome coronavirus 2><prototype><pulmonary><repository><research and development><sample collection><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 positive patient><specimen collection><success><tool><transplant patient><viral infection><virus infection><virus-induced disease>