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CONTRACT RESEARCH

  • Pre-therapeutic patient screening

  • Post-therapeutic study and patient monitoring

  • Pharmacokinetic studies

  • Biomarker development

  • Companion diagnostic testing

  • IVDs and LDTs

Nucleic acid-based assays

•Genetic mutation

•Gene expression

•Companion diagnostic

•Biomarkers

•Liquid biopsy

•Vector and other nucleic acid therapeutic agent distribution and shedding

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Immunoassays & Immunogenicity test

•Binding antibody and neutralization antibody test

•Immunogenicity test including ADA,

•Biomarker (antibodies, cytokines, immunophenotyping)

•T-cell and B-cell  functional assay

•Other cell-based assays

MICROBIOLOGY

•BSL-2 enabled

•Virus vector-based studies

•Molecular testing

•immunoassays

•Copy number determination

The analyzers are either FDA-cleared Dx models, or compliant with CFR 21 Part 11

Testing Platforms

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Laboratory Quality Management System

Quality Management System

Compliant with CLIA, CAP, GLP, and GCP requirements, the system includes quality assurance, KPIs, CAPA, and more.

​Operational Management System

Managing the purchasing process, inventory system, document controls, and more.

Specimen Management System

Facilitating chain of custody throughout the specimen lifecycle, including kitting, shipping, receiving, testing, quality control (QC), reporting, and archiving, with a comprehensive audit trail.

​Analyzer Data Transfer and Integration System

Facilitating secure and accurate transfer of raw data from analyzers to the in-house server and the client's portal.

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