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Transforming transplant and immunogenetics research with our broad menu of specialty laboratory services
With an array of innovative research assays, molecular profiling, and proteomics, our clinical research laboratory provides the tools necessary to help advance your research project.
Broad menu of specialty laboratory services
| Workflows | Equipment | Clinical assays |
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| Real-Time qPCR |
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| Flow Cytometry |
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| Mass Spectrometry |
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| HLA Typing |
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| Microarray Analysis |
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One Lambda Laboratories advantage
- Experienced professional guidance: confidence you’re in the right hands to enable success now and into the future
- Accelerate your project: your time from data to insight is valuable – help achieve your objectives faster than on your own
- Global support network: leverage Thermo Fisher’s global support network with One Lambda experience
- Cost-effective: maintain control over your time and budget. Tailor your service to match your needs
An inside look at One Lambda Laboratories
Our Thermo Fisher Scientific clinical research laboratory delivers advanced testing services, offering precise analysis of genetic markers and biomarkers that provide the tools necessary to help advance your clinical research. Our advanced tests provide personalized information that support the long-term success of organ transplants.
Areas of research services offered
Learn more about our comprehensive testing services spanning applications in pre and post-transplantation, gene cell therapy, oncology research, and immunology.
Companion diagnostics
Companion diagnostics are tests that are developed and used in conjunction with specific therapeutics to identify patients who are most likely to benefit from the treatment or to monitor their response to the therapy.
Partnering with companion diagnostic experts allows access to experienced professionals, cost efficiency, and regulatory compliance.
Document preparation and review
- Design history files, technical document compilation
- Device pre-submission to the FDA
- Regulatory feedback
- Registration file compilation and co-submission
Clinical trial assay management
- Biomarker eligibility guidance
- Clinical trial assay (CTA) site coordination
- Study risk determination (SRD)
- Institutional review board (IRB) applications
- Investigational device exemption (IDE) applications
- Data collection and management
- Clinical trial support and management
Technical support
- Clinical trial assay training and implementation
- Product-related
- Registration questions
- Document legalization
- Assay and study permits
- Data management and bioinformatics
Regulatory service
- >15 years of IVD experience
- Experience outside US and EU
- Regulatory support for optimal assay design
- Regulatory support for clinical trial assay implementation to minimize regulatory risk
Not all products are CE marked or have 510(k) clearance for sale in the U.S. Availability of products in each country depends on local regulatory marketing authorization status.