Support Across the Full Biomarker Continuum from Discovery to Clinical Implementation
The Instrument Powering the Simoa Accelerator
Introducing the world’s most sensitive, fully automated immunoassay platform with multiplexing and custom assay capability.
Up to 1000x greater sensitivity
Up to 4 biomarkers in a single assay
Compatible with 80+ assays
Why Simoa Accelerator
Our team brings unique insight into assay performance, analytical workflows, and biomarker implementation strategies while operating within rigorous quality and compliance frameworks.
With one of the largest installed fleets of Simoa instruments and access to partner testing sites worldwide, we support both regional and global biomarker programs, including studies with complex sample logistics and multinational clinical trial requirements.
Our team has extensive experience developing customer-specific biomarker assays, supporting lot bridging strategies, external quality controls, longitudinal testing programs, and small-batch manufacturing for translational studies.
Biomarker Services Designed Around Your Program
Every biomarker program has unique scientific, operational, and regulatory requirements. Whether you’re developing a novel assay, generating biomarker data for a clinical study, or advancing a biomarker toward clinical implementation, the Simoa Accelerator provides the expertise, technology, and testing capabilities needed to move programs forward with confidence.
Custom Biomarker & Assay Development
When commercial assays are unavailable—or when existing assays require adaptation for a specific matrix, study design, or biomarker target—our Custom Assays & Research (CARe) team develops fit-for-purpose solutions that support translational and clinical research objectives.
Capabilities:
- Custom biomarker assay development
- Novel reagent development
- Antibody screening and optimization
- Matrix-specific assay validation
- PK, PD, ADA, and autoantibody assay development
- DBS and specialty sample workflows
- Fit-for-purpose, full, and clinical validation
- Small-batch assay manufacturing
Clinical Biomarker Testing
The Accelerator laboratory provides regulated biomarker testing services designed to support translational research, therapeutic development, and clinical trial execution. Our high-throughput testing workflows generate reproducible biomarker data across exploratory, longitudinal, and registration-enabling studies.
Capabilities:
- Clinical trial biomarker testing
- Longitudinal monitoring studies
- PK/PD biomarker assessment
- Cohort stratification studies
- Multi-site biomarker programs
- Bridging studies and EQC implementation
- Regulatory-ready reporting
Therapeutic Areas
- Neurology
- Immunology
- Oncology
Clinical Development & Diagnostic Support
Our Accelerator laboratory helps bridge the gap between biomarker discovery and clinical implementation through validated workflows, quality systems, and diagnostic development support. From clinical trial biomarkers to laboratory-developed tests, we help establish the analytical confidence required for clinical adoption.
Capabilities:
- Quality and compliance consultation
- Method validation
- Longitudinal bridging strategies
- Regulatory documentation support
- LDT implementation readiness
- Companion diagnostic feasibility support
- Multi-site harmonization strategies
How We Accelerate Biomarker Programs
Access world-leading ultra-sensitive biomarker technology through service models that enable immediate project execution without instrument ownership.
Expand beyond currently available biomarker menus through custom assay development, validation, and scientific collaboration.
Execute biomarker programs at scale through regulated workflows supported by quality systems, clinical laboratory expertise, and validated processes.
Support Across the Biomarker Development Process
Project Definition
- Study design consultation
- Biomarker strategy
- Scope development
- Technical requirements
Initiation
- Project planning
- Sample logistics
- Material acquisition
- Kickoff alignment
Execution
- Biomarker testing
- Assay validation
- Data generation
- Quality review
Reporting & Delivery
- Data interpretation
- Reporting
- Deliverables
- Future study planning
Bench-to-Market Diagnostic Development
For diagnostics to truly have an impact, results must be consistent and reproducible regardless of which lab performs the test or who runs the assay.
Our development solutions focus on delivering consistent, reproducible results across laboratories, instruments, and operators. Our approach follows a rigorous, risk-based framework aligned with FDA expectations and ISO 13485 quality standards, helping ensure reliable performance from development through commercialization.
LDT, CDx Development
Whether you are launching your first assay development program or expanding an established pipeline, the Simoa Accelerator team operates as an extension of your team – collaborative, responsive, and committed to shared success. We provide technical and strategic partnership across the full program lifecycle including project management and milestone support, and regulatory support for FDA submissions.
Together, we can help translate innovation into meaningful impact.
- Clinical trial assay development & validation
- Patient testing
- Diagnostic readiness
- Regulatory support
Service Levels
Flexible engagement models designed to support exploratory research through clinical stage biomarker programs
Research Use Only
Accelerate Biomarker Discovery
Designed for exploratory research, biomarker characterization, assay evaluation, and hypothesis generation with maximum flexibility and rapid turnaround.
Accelerate your:
- Biomarker discovery
- Translational research
- Early-stage drug development
- Feasibility & pilot studies
- Academic & investigator sponsored research
Deliverables Included:
Processed Research Datasets
Data Files and Summary Reports
Scientific Consultation and Interpretation Support
Premium
Clinical Trial-Ready Biomarker Testing
A fit-for-purpose solution for clinical development with enhanced analytical rigor, longitudinal consistency, and regulatory alignment.
Accelerate your:
- Clinical trials (Phase I-IV)
- Companion diagnostic feasibility studies
- Patient stratification programs
- Regulatory-supportive biomarker studies
- Longitudinal monitoring programs
Deliverables Included:
Validated Biomarker Results
Statistical Quality Reports
Levy-Jennings Trend Analyses
Custom Data Transfers & Integration Support
Regulatory-Ready Documentation Packages
LDT
Clinical Decision Support Testing
Clinical-grade laboratory testing under a CLIA-compliant quality system to support patient-level clinical decision-making.
Accelerate your:
- Clinical decision support
- Precision medicine programs
- Diagnostic implementation
- Patient selection strategies
- Real-world clinical testing
Deliverables Included:
Clinical Reports
Interpreted Patient Results
Full Audit Trail Documentation
Secure Portal Delivery
Quality and Medical Review Oversight
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