Specialty testing
Advanced testing for complex development challenges
We offer specialty testing across bioanalytical, cell-based, molecular/genomic, and sequencing domains, supported by GLP/GCP expertise.
Core specialty areas
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Bioanalytical testing for PK/TK, immunogenicity (ADA, NAb), and biomarkers – delivered on platforms such as MSD®‑ECL, Luminex®, ddPCR, ELISpot, and flow cytometry.
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Custom assay development & validation – fit‑for‑purpose design, optimization, transfer, and validation across 16+ platforms.
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Molecular & genomic assays – qPCR/RT‑ qPCR/ddPCR, genotyping, NGS and Sanger, plus NanoString® for robust expression analysis.
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Sequencing & precision oncology – CGP with TSO500 (PanCancerIQ™), WES, and RNA‑Seq to inform selection and response.
Cell‑based & immunogenicity assays
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Flow cytometry (including spectral) for immunophenotyping, receptor occupancy, and functional readouts – custom panels validated for clinical use.
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ELISpot/FluoroSpot for T/B‑cell responses, NAb readouts, and cytokine secretion with CTL Series S6 imaging.
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Functional assays (ADCC/CDC) and cell‑based NAb methods to characterize mechanism and safety risk.
Molecular & genomic testing
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qPCR/RT‑qPCR/ddPCR for biodistribution, persistence, and viral shedding – built on deep infectious‑disease and gene‑therapy expertise.
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NanoString® nCounter® Pro for high‑confidence expression signatures from challenging or limited samples.
Sequencing for clinical decisions
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Comprehensive genomic profiling (PanCancerIQ™) with Illumina TSO500 for SNVs/indels, CNVs, RNA fusions, and reporting of MSI/TMB in FFPE and liquid biopsy.
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Whole exome sequencing (WES) – analytically validated across saliva, buccal swab, and whole blood matrices, supporting broad genomic endpoints.
Vaccine & infectious disease specialties
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Assay portfolio for vaccine trials – immunogenicity (ADA/NAb), cytokine release, TCID50, respiratory pathogen panels, and NGS for variant tracking.
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Global kits & logistics – three owned kit‑packing hubs and PBMC network to protect integrity and timelines.
Quality, analytics & matrices
We operate under GLP/GCP and GCLP‑aligned quality systems in our fully consolidated Lenexa facility, supported by secure electronic records and rigorous data‑integrity controls.
Our Bioinformatics & AI Center strengthens every study with advanced NGS pipelines and analytics – including variant calling, viral variant reporting, and multi‑omics outputs – delivered in submission‑ready formats.
We support a broad range of study‑validated matrices, including FFPE tissue, whole blood and plasma (ctDNA), saliva, buccal swabs, nasal swabs, and more.
Together, these capabilities ensure clients receive high‑quality, defensible data and a smoother, more reliable path from sample to regulatory‑ready insight.
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