Biomarker assay development and validation services across multiple platforms that brings the high-quality, regulatory-ready data your program needs.
The most demanding programs rarely fit into a single modality. CellCarta's expertise and biomarker capabilities are built to span tissue, gene, protein, and immune response without compromising quality or continuity.
CellCarta brings state-of-the-art laboratory techniques and scientists with decades of experience designing, developing, and validating custom panels for specific clinical needs.
With specialist expertise, we can guide your biomarker strategy at every stage, providing:
Managing biomarker programs across multiple vendors is complicated, with inconsistent processes and handovers putting data, timelines, and submissions at risk.
CellCarta’s biomarker solutions consolidate your program under one roof, removing the inconsistency and handover risk that comes with managing multiple vendors. We offer:
Proven and emerging molecular platforms for clinical sample analysis and reporting.
Multiplexed tissue analysis with in-house pathologists and AI-powered image analysis.
Validated immunoassay platforms for precise biomarker quantification and clinical testing.
Validated immunoassay platforms for precise biomarker quantification and clinical testing.
Fully integrated MS platforms and immunoassays for discovery and bioanalytical testing.
Our biomarker solutions are provided under a quality framework that ensures your data stands up to regulatory review.
Generate data that meets global regulatory standards with CellCarta’s quality management system (QMS), implemented at every level of the organization.
Test with confidence in laboratories that meet the highest international standards.
Protect sample integrity at every stage with meticulous, end-to-end sample management.
Case Study
CellCarta presents a High-Resolution Mass Spectrometry (HRMS) workflow to measure M-protein levels from as little as 10 µL of sample. This is a non-invasive, sensitive, and precise quantification method that can be employed for clinical oncology research.
Case Study
CellCarta validated a simplified pathologist scoring method to classify tumor immune phenotypes (Inflamed, Excluded, Desert) via CD8+ IHC. Achieving up to 97% inter-pathologist concordance across NSCLC, CRC, and urothelial cancers, the method enables reproducible immune profiling for immuno-oncology trials.
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Biomarker services are integrated scientific offerings that identify, develop, validate, and measure biological indicators used to guide clinical development, patient stratification, and regulatory decisions. They are critical because biomarkers serve as diagnostic, prognostic, or predictive tools that reduce failure rates in drug development and support FDA, EMA, PMDA, and NMPA submissions.
CellCarta delivers end-to-end biomarker solutions across various therapeutic areas and capabilities, combining discovery, assay development, validation, and clinical testing under one program. This integrated model reduces vendor fragmentation, protects data integrity, and accelerates go/no-go decisions from Phase I through Phase IV.
CellCarta offers end-to-end biomarker services spanning biomarker discovery, assay development and customization, fit-for-purpose validation, clinical sample analysis, and companion diagnostic (CDx) development. Services run across our validated platforms: flow cytometry (TBNK, MDSC), mass cytometry (CyTOF, up to 40 markers), ELISpot and FluoroSpot, multiplexed immunoassays on MSD®, Olink™, and Ella™, histopathology with multiplex IHC, ISH, and digital pathology, molecular assays for DNA and RNA, and mass spectrometry for proteomics. Every project is led by PhD-level scientists and executed in GCLP and CAP-accredited, CLIA-certified global laboratories.
Yes. CellCarta delivers biomarker services in GCLP-compliant, CAP-accredited, CLIA-certified testing sites across our globally owned facilities. CAP accreditation is recognized by CMS as meeting or exceeding CLIA requirements, and GCLP bridges GLP and GCP for clinical trial sample analysis, covering pre-analytical, analytical, and post-analytical processes.
Every assay follows documented SOPs, validated data management systems, and harmonized protocols, producing data suitable for FDA, EMA, PMDA, and NMPA submissions and for progression toward companion diagnostic qualification. Sponsors running multi-region studies benefit from directly comparable data without requalification across sites.
Biomarker discovery identifies candidate biological indicators correlated with disease, treatment response, or safety, typically using exploratory, high-content platforms such as mass cytometry, proteomics, or NGS. Biomarker validation confirms that a selected candidate is accurate, reproducible, and fit for intended use, through analytical and clinical validation aligned with FDA BMV, ICH M10, and ISO 15189 expectations. CellCarta covers both stages within one biomarker solutions organization, so candidates identified during discovery move seamlessly into method development, fit-for-purpose validation, and regulated clinical deployment, reducing transfer risk and shortening program timelines.