What Sword Bio does

Sword Bio (legal entity Sword Diagnostics, Inc., Delaware) is a GLP-compliant bioanalytical contract research organization providing assay development, validation, and sample analysis services to biotech and pharmaceutical companies developing biologic therapeutics, including monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs), gene therapies, cell therapies, and biosimilars. Core offerings span Ligand Binding Assays (LBAs) including ELISA and Meso Scale Discovery (MSD) electrochemiluminescence platforms for pharmacokinetic (PK), immunogenicity (ADA and NAb), and biomarker quantification, complemented by cell-based assays, molecular assays (qPCR, dPCR), and flow cytometry. The proprietary Sword Swift™ reagent system delivers MSD-comparable detection sensitivity using standard fluorescent-plate-reader ELISA infrastructure. Services are executed under Non-GLP, GLP, and GCLP conditions and span discovery through clinical Phase IV, supporting IND, BLA, and MAA submissions.

The company operates through a direct sales-led GTM via VP-level business development executives covering the US East and West Coasts and senior scientific leadership engaging sponsors directly. Pricing is custom and project-based with no minimum project requirement, and project kickoff typically begins within 10-15 business days from signed scope. Sword Bio is privately held and founder-led by CEO David Dingott; scientific strategy is led by CSO Dr. Jim McNally (ex-BioAgilytix, CRISPR Therapeutics, Genzyme, Pfizer, EMD Serono, Shire). Operations are anchored by headquarters in Carmel, Indiana and the primary bioanalytical laboratory in Chicago, Illinois. Sponsors are biotech and pharma developers of biologics across preclinical and clinical stages, with modality emphasis on antibody therapeutics, gene and cell therapies, and bispecific or ADC programs.

Name

Sword Bio

Legal name

Sword Diagnostics, Inc.

Website

https://swordbio.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Sword Bio is a GLP-compliant bioanalytical contract research organization providing Ligand Binding Assay, pharmacokinetic, immunogenicity, and biomarker services for biotech and pharma developing biologics, using proprietary Sword Swift™ reagents with labs in Carmel, IN and Chicago, IL.

Ownership category

akta.pro rank

Product category

Bioanalytical Contract Research Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD)

akta.pro secondary industries

Bioanalytical Testing (PK/ADA/NAb) (HLAGADAA), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Bioanalytical services
• Contract research organization
• Pharmacokinetic assays
• Immunogenicity testing
• Biomarker assay development

Headquarters

HQ city

Carmel

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Contract Research Services: Sword Bio operates as a contract research organization (CRO) providing bioanalytical services including assay development, validation, and sample analysis for biotech and pharmaceutical companies. Services are delivered on a project-by-project basis supporting preclinical and clinical studies under GLP, GCP, and RUO conditions. Revenue is generated through service fees for method development, validation, and sample testing projects of varying scope.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Sword Bio is a GLP-compliant bioanalytical contract research organization (CRO) that provides regulated laboratory services — assay development, validation, and sample analysis — to biotech and pharmaceutical sponsors developing biologic therapeutics, antibody therapeutics, cell therapies, and gene therapies. Services span pharmacokinetics, immunogenicity (ADA/NAb), biomarker quantification, cell-based assays, and molecular assays under GLP, GCLP, and RUO conditions. The company also offers the proprietary Sword Swift™ high-sensitivity ELISA detection reagent system.

Product overview

Sword Bio is a GLP-compliant bioanalytical contract research organization (CRO) offering a comprehensive portfolio of laboratory services for drug discovery and development. The company's offerings are organized as core service lines rather than a unified software platform. The portfolio includes Bioanalytics (Ligand Binding Assays), Pharmacokinetics (PK) Assays, Custom Biomarkers, Immunogenicity (ADA & NAb) testing, MSD Assays (singleplex and multiplex immunoassays), and the proprietary Sword Swift™ high-sensitivity ELISA reagent system. Complementary services include Cell-Based Services and Molecular Services for cell and gene therapy support. All services support preclinical and clinical stages under Non-GLP, GLP, and GCLP conditions, with expertise spanning antibody therapeutics, gene therapies, and small/large molecule biologics.

Differentiator

Problem solved

Functional benefit

Products and services

• Bioanalytics (Ligand Binding Assay Development) Rapid development, optimization, qualification, and validation of Ligand Binding Assays (LBAs) tailored to client-specific needs for therapeutic proteins, serology, vaccines, nucleic acids, and immuno-oncology applications, run under Non-GLP or GLP conditions. The service supports immunogenicity assays, neutralizing antibody (NAb) assays, cell-binding assays, receptor binding phosphorylation assays, PK assays, PD assays, receptor occupancy assays, functional whole cell assays, and serology/vaccine development applications.
• Pharmacokinetics (PK) Assays Development, qualification, and validation of sensitive quantitative assays to measure the pharmacokinetic activity of novel therapeutic drugs for preclinical and clinical studies under Non-GLP or GLP conditions.
• Custom Biomarkers Development, qualification, validation, and sample analysis 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 preclinical or clinical samples.
• Immunogenicity (ADA & NAb Assays) Development and validation of anti-drug antibody (ADA) and neutralizing antibody (NAb) methods including bridging assays, direct-binding assays, ACE, and SPEAD formats designed to meet client-specific project needs.
• MSD Assays (Meso Scale Discovery) Complete suite of MSD singleplexed and multiplex immunoassays for biomarker quantitation supporting drug discovery, nonclinical, and clinical validation needs using S-PLEX, V-PLEX, U-PLEX, R-PLEX, and T-PLEX formats across all regulatory settings.
• Sword Swift™ (High-Sensitivity ELISA Detection Reagents) Proprietary high-sensitivity ELISA detection reagents and signal amplification system, paired with a proprietary method development workflow, that provides sensitivity comparable to MSD assays for biomarker, protein, and therapeutic quantitation while being more cost-effective. Includes advanced signal amplification techniques that achieve lower detection limits and greater precision than standard ELISA systems, with assay development matching validated MSD sensitivity using standard fluorescent plate readers and HRP detection.
• Cell-Based Services Comprehensive suite of cell-based assay services including mechanism of action studies, CMC lot release and stability assessments, cellular immunogenicity assessments, and cytotoxicity evaluations using cell lines or primary cells.
• Molecular Services Molecular assays supporting cell and gene therapy development including qPCR, digital PCR (dPCR), CAR-T therapy support, AAV viral services, VCN testing, and gene expression analysis.
• Antibody Therapeutics Bioanalytical Support Specialized bioanalytical services for monoclonal antibodies, multidomain proteins, antibody-drug conjugates (ADCs), and biosimilars using ELISA and MSD platforms for PK, immunogenicity, and biomarker assessments.

Quantifiable outcome

• Projects typically initiate within 10-15 business days
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators4 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• BioAgilytix: BioAgilytix is a specialized bioanalytical CRO offering PK, immunogenicity, biomarker, and cell-based services for biologics and gene therapies. It is the most direct competitor to Sword Bio, and two senior Sword Bio leaders (CSO Jim McNally, former CSO; VP BD West Coast Michael Losauro, former Senior Director of Strategic Accounts) joined from BioAgilytix.
• Eurofins Bioanalytical Services: Eurofins Bioanalytical Services provides small and large molecule PK, immunogenicity, and biomarker assay development across global lab sites. Direct competitor in the same LBA/MSD/immunogenicity service lines and a credible alternative for sponsors evaluating outsourced bioanalytical work.
• Celerion: Celerion is a clinical bioanalytical CRO offering PK/PD, immunogenicity, and biomarker services for early-stage clinical development. Directly comparable in size, modality focus, and target customer base.
• Frontage Laboratories: Frontage provides bioanalytical, CMC, and preclinical services with strong LBA and biomarker capabilities serving biotech and pharma sponsors. Comparable in service mix and customer profile, with a larger U.S. and China footprint.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO with bioanalytical capabilities supporting complex biologics and rare disease programs. Comparable in scale and emphasis on scientific engagement versus pure scale.
• Cambridge Biomedical (now part of a CRO platform): Cambridge Biomedical was a bioanalytical CRO specializing in PK, biomarker, and immunogenicity services, previously owned by Sword Bio's EVP of Sales and Marketing David Osband. The closest historical analog in scientific positioning even if its current ownership has changed.

Broad incumbents

• Charles River Laboratories: Charles River is a large CRO offering bioanalytical, safety, and manufacturing services including the Skokie molecular biology unit that AM Rom (Sword Bio GM) previously led. It competes with Sword Bio on LBA, biomarker, and molecular services, but as part of a much broader portfolio.
• Q² Solutions: Q² Solutions is a clinical trials laboratory services joint venture (IQVIA/Quest) offering bioanalytical, central lab, and biomarker services. Competes with Sword Bio on bioanalytical work for clinical trials, but as part of a global full-service lab offering.
• Labcorp Drug Development (now Fortrea): Labcorp Drug Development (spun off as Fortrea) operates a large central bioanalytical lab serving global clinical trials. Overlaps with Sword Bio in PK and immunogenicity support but at a fundamentally larger scale and broader scope.
• PPD (Thermo Fisher Scientific): PPD, now part of Thermo Fisher's clinical research business, offers large-scale bioanalytical and central lab services for global clinical trials. Overlaps with Sword Bio on biomarker and immunogenicity work but operates at a much larger scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sword Bio