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Tailored solutions support for the entire assay lifecycle
Contract Research
With over 15 years of expertise in laboratory diagnostics, AttoDiagnostics provides high-quality contract research, assay development, and validation services for biotech companies, diagnostic assay manufacturers, and research institutions. Our tailored solutions support the entire assay lifecycle, from concept to regulatory approval.
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Comprehensive Assay Development & Validation
AttoDiagnostics offers end-to-end assay development services, ensuring precision and reliability in diagnostic testing. Our capabilities include:
- Custom Assay Design – Development of molecular, immunological, and biochemical assays tailored to specific research and diagnostic needs.
- Analytical & Clinical Validation – Rigorous performance evaluation, including sensitivity, specificity, and reproducibility assessments.
- Regulatory Support – Compliance with ISO 17025, ISO 13485, and CE-IVD/FDA requirements for assay validation.
- System Compatibility Testing – Evaluation of assay performance across different instrumentation platforms.
Fast Turnaround Times
Speed is critical in assay development and validation. AttoDiagnostics ensures a turnaround time (TAT), depending on project complexity, enabling rapid progression from development to market.
Seamless Integration & Data Reporting
We provide structured data reporting and analysis, with options for direct API integration into laboratory information management systems (LIMS), ensuring seamless project tracking and data accessibility.
Our Core Services
AttoDiagnostics supports a wide range of research and development initiatives, offering:
Get a QuoteContract Research Services
Bespoke research projects tailored to diagnostic and biotech innovations, including:
- Biomarker Discovery – Identification and validation of novel diagnostic biomarkers.
- Pathogen Detection Studies – Evaluation of molecular and immunological assays for infectious disease detection.
- Pharmacogenomics & Companion Diagnostics – Assay development for precision medicine applications.
Assay Development & Validation
Comprehensive support for new and existing diagnostic assays:
- Molecular Assay Development – PCR, qPCR, and NGS-based test development.
- Immunoassay Development – ELISA, lateral flow, and chemiluminescence assays.
- Analytical Performance Studies – Assessment of precision, linearity, limit of detection (LoD), and limit of quantification (LoQ).
- Clinical Validation Studies – Large-scale validation studies in compliance with regulatory standards.
System Evaluation & Instrumentation Testing
Ensuring compatibility and performance across diagnostic platforms:
- Cross-Platform Validation – Verification of assay reproducibility on multiple diagnostic instruments.
- Automation & Throughput Testing – Evaluation of automated workflows for high-volume testing.
- Reagent Stability & Shelf-Life Studies – Long-term stability assessments for diagnostic reagents.
Get Started with AttoDiagnostics
Whether you are developing a novel diagnostic assay, seeking validation for regulatory submission, or evaluating system performance, AttoDiagnostics delivers expert research and development support. Partner with us to accelerate innovation, ensure compliance, and bring cutting-edge diagnostics to market with confidence.
Contact us today to learn more about our contract research and assay development services.
