SARS-CoV-2 PCR tests
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Qualitative to support patient enrollment (inclusion/exclusion)
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Quantitative to support efficacy endpoint
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| Serological antibody tests |
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Qualitative total immunoglobulin (Ig) to support patient enrollment (inclusion/exclusion)
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Qualitative and quantitative IgM and IgG to identify early versus late infection
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Quantitative IgM and IgG titers to assess drug off-target effects
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Vaccine assays
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Immunogenicity: Spike and nucleocapsid antigen specific quantitative ELISA antibody measurement
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Developing a neutralization assay through a collaboration with University of Texas Medical Branch
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Partnership with the Coalition for Epidemic Preparedness Innovation (CEPI) to harmonize evaluation of multiple COVID-19 vaccine candidates
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SARS-CoV-2 specific T-cell response assessment
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SARS-CoV-2 surrogate neutralization assay, used under license from the Albert Einstein College of Medicine
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Cytokine panels
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Detection of cytokines including IL-1β, IL-2, IL-4, IL-6, IL-7, IL-10, IFN-γ, GCSF, IP-10, MCP-1, MIP-1α, TNF-α to monitor cytokine storm
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Comprehensive portfolio of genomic assays
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SARS-CoV-2 complete viral genome sequencing by NGS
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Host transcriptomic analysis by RNA sequencing and targeted analyses
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Host genomic analysis by whole exome sequencing and targeted genotyping
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Host metagenomic analysis by 16S RNA metagenomic sequencing
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DNA and RNA sequencing
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Gene expression panels for inflammatory and immune response monitoring
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Comprehensive flow cytometry panels utilizing cutting-edge next-generation instruments
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T cells: CD3+CD4+CD8-/CD3+CD4-CD8+ ratio, CD3+CD4+IFN-γ+, CD3+CD8+CD38+HLA-DR+, Th, Th1, Th2, Th17, T-Follicular helper, Treg naïve/memory and intracellular staining: IL-2, IL-4, IL-6, IL-17A, IFN-γ GM-CFS, Granulysin, Granzyme B, Perforin, and TNF-α
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B cells: Plasmablasts, plasma cells – short-lived/long-lived, and memory B cells
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Monocytes: Blood monocyte shift to inflammatory phenotype
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Macrophages: Broncho-alveolar lavage
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Monocyte-derived dendritic cell analysis
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Conventional safety markers for prognostic evaluation
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Chemistry: Ferritin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), hyper-sensitive troponin I, lactate dehydrogenase (LDH), C-reactive protein (CRP), procalcitonin, albumin
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Hematology: WBC, neutrophils, lymphocytes and platelets counts
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Disseminated intravascular coagulation (DIC): Prothrombin time (PT), partial thromboplastin time (aPTT), and D-dimer
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Bioanalytical services
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Large molecule PK, immunogenicity/anti-drug antibody ligand-binding assays
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Small molecule PK and drug-drug interaction
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