Custom Biomarker Assay Services

Our team of Biomarker experts have 30+ years of experience helping support small and large Biopharma clients with their custom biomarker assays.

We offer development, qualification, validation and sample analysis services for nonclinical and clinical trials.

The Sword Difference

At Sword Bio, our scientists have extensive experience in the development, qualification, and validation of sensitive, accurate, and precise quantitative assays to measure protein and non-protein biomarkers of drug efficacy, toxicity, and disease diagnosis, progression, or recurrence in your preclinical or clinical samples.

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How Our Team Can Help

  • Can develop client specific biomarkers using specific Antibodies
  • Assay development, qualification, validation and sample testing
  • Singleplexed biomarker immunoassays
  • Multiplexed panels of biomarker immunoassays
  • Proprietary immunoassay kit development and manufacturing
  • Services can be provided under Non-GLP or GLP
  • Services can support both nonclinical and clinical drug development
  • Fit-For-Purpose
  • Can screen all pre-dose matrices for client specific biomarkers

Some of Our Available Biomarker Assays

Proinflammatory, Cytokine, Chemokine, Vascular, Angiogenesis Panels, and more.

Below is an example of some of the qualified biomarkers we currently run, please reach out for a full list:

V-PLEX Human Biomarker 40-Plex Kit
IFN-γGM-CSFIL-8(HA)VEGF-C
IL-1βIL-5MCP-1VEGF-D
IL-2IL-16MCP-4Tie-2
IL-4IL-7EotaxinVEGFR-1/Flt-1
IL-6IL-12/IL-23p40IP-10PIGF
IL-8IL-1αMDCFGF (basic)
IL-10VEGF-AEotaxin-3SAA
IL-12p70IL-17ATARCCRP
IL-13IL-15MIP-1αVCAM-1
TNF-αTNF-βMIP-1βICAM-1
40-plex

Critical Processes
In Drug Development

Establishing a profile of specific cellular and tissue proteins whose increase or decrease in concentration with treatment can serve as surrogate biomarkers of drug efficacy, is a critical step in the drug development process.

Sword scientists have extensive expertise in the development of quantitative methods to identify and qualify cellular biomarkers of treatment efficacy or toxicity for both large and small molecule potential therapeutics.  Singleplex and multiplex formats can be developed on the standard ELISA plate reader or the more versatile MESO QuickPlex SQ 120.

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Cystatin C (V57D mutant). Protein used as biomarker of kidney function. 3D rendering based on protein data bank entry 3sva. Stick representation combined with semi-transparent surfaces. Dark background.

End-to-End Biomarker Assay Support

At Sword Bio, we provide end-to-end support for custom biomarker assay services tailored to preclinical and clinical programs. Our team partners with clients to design assays that are sensitive, reproducible, and fit-for-purpose for their unique therapeutic area and stage of program development.

Our Capabilities Include

Assay Development

Method creation for novel biomarkers using platforms such as ELISA and MSD. We design assays to meet required sensitivity, specificity, and reproducibility standards.

Assay Qualification

Rigorous evaluation of performance characteristics such as precision, linearity, selectivity, and stability before moving into validation.

Assay Validation

Full GLP validation performed to regulatory expectations, ensuring readiness for clinical trial support.

Sample Analysis

High-throughput processing of study samples using singleplex or multiplex panels, enabling robust data generation across multiple biomarkers simultaneously.

Why Fit-for-Purpose Matters

Each program has different objectives and regulatory requirements. Sword Bio applies a fit-for-purpose philosophy—optimizing assay rigor according to study phase and intended use. For early discovery, we focus on speed and sensitivity; for pivotal clinical studies, we ensure assays meet regulatory standards for decision-making. This approach reduces development timelines while preserving scientific integrity.

Industry Recognition & Differentiators

Sword Bio has been recognized as the Most Innovative Collaborative Bioanalytical Lab 2024 – USA, underscoring our commitment to scientific excellence and client partnership.

What Sets Us Apart

  • Collaborative Culture: Every client project receives a dedicated team with direct scientific engagement throughout the process.
  • Flexible Study Design: We accept projects of all sizes, with no minimum requirements, allowing biotech and pharma companies of all sizes to access expert bioanalytical support.
  • Rapid Project Startup: Our streamlined onboarding enables studies to begin faster, accelerating timelines for critical decisions.
  • White-Glove Service: We provide transparent communication, timely reporting, and proactive troubleshooting to ensure success across complex programs.

Frequently Asked Questions

What platforms do you use for biomarker assays?

Do you support both GLP and non-GLP studies?

What types of biomarkers can you measure?

How do you ensure biomarker assays are scientifically rigorous and reproducible?

Why choose Sword Bio over other CROs?