Let Our CRO Team Fast-Track Your ELISA Assays
As pioneers in the immune monitoring arena, the Contract Research Laboratory Services team has more than a decade of proven expertise in performing high-throughput immunological assays, including ELISA.
Our CRO has developed and validated various customized ELISA assays for pharmaceutical and biotechnology Clients—large and small—spanning diverse antigenic systems including AAV, SARS, and cancer antigens, just to name a few. We have successfully deployed such validated assays in key clinical trials, translational and preclinical studies, and commercial CLIA-LDT assays.
ELISA is an effective quantitative assay to assess immunogenicity. For a more comprehensive analysis, we recommend coupling ELISA with other immunoassays like ELISPOT that our CRO can assist you with.
Let us help you reach your project milestones faster. Reach out to our experienced ELISA team today.
ELISA Optimization, Validation, and Sample Testing Services
The CRO can develop and validate a wide array of customer-specific ELISA assays to assess various analytes including antigens, antibodies (and their isotypes), or cytokines just to name a few.
ELISA-Based Diagnostic Tests
Our CRO also specializes in developing Laboratory-Developed Tests (LDTs) for diagnostic purposes. These custom assays use analyte-specific reagents (ASRs) to identify and quantify individual analytes of interest. These ASRs can include antibodies (polyclonal or monoclonal), receptor proteins, nucleic acid sequences, etc.
Our CLIA-certified contract laboratory specializes in LDTs tailored to your needs, in accordance with FDA Bioanalytical Method Validation Guidance for Industry.
We currently offer three diagnostic ELISA assays:
- ELISA-based detection of AAV9 capsid IgG antibody in serum and plasma specimens (approved by NY Project ID: 62201 PFI: 9337: Human anti-AAV9 IgG ELISA assay)
- Human anti-SMN IgG ELISA (validated and submitted)
- Human anti-SARS CoV-2 IgG ELISA (validated and submitted)
Many such optimized assay services have helped our Pharma and Biotech Clients evaluate immunogenicity in preclinical studies and clinical trials in oncology, gene therapy, infectious disease systems, vaccines, and immunotherapeutics.