Get to know our Immune profiling services

Our highly trained team of immunologists leverage knowledge of immune response, disease understanding and therapeutic expertise to provide a diverse set of tools for immune monitoring and profiling. We have multiple universal assays developed that will give you more answers for the same sample volume.

Measurable Residual Disease Detection and Monitoring

Measurable residual disease (MRD, also referred to as minimal residual disease) refers to the small number of cancer cells that remain in the body after treatment, even when the patient is in remission. Multiple studies demonstrated lower MRD correlates with superior survival, thus, sensitive, and reliable detection methods can enable development of more effective treatments. MRD can be detected by using sensitive techniques such as flow cytometry, next-generation sequencing, or digital PCR, which can measure one cancer cell among millions of normal cells. Detecting and monitoring MRD not only provides important information about the effectiveness of treatment but also predicts risk of relapse, which could indicate the need for alternative therapy.

Navigate BioPharma Services offers a variety of MRD testing solutions for clinical trials to sensitively and reliably monitor tumor burden in patients and assist with understanding the efficacy of investigational treatments. These powerful tools can ultimately be used to support real world efficacy and drug reimbursement for specialized therapies, such as CAR-T.

There are special benefits to incorporating flow cytometry-based MRD methods in clinical trials of blood cancer patients, including the phenotype of both the original tumor cell and escape variants, density or loss of target antigens and the coverage for a diverse group of blood cancers.  

Utility of MRD Test Methods 

• Assess clinical response and prognosis
• Strengthen clinical response interpretation e.g., MRD negativity in Complete Responders
• Guide the optimization of treatment strategies e.g., need for a stem cell transplant
• Monitor the patient's disease status during follow-up and detect any signs of relapse before clinical presentation

Table 1: Available MRD Flow Test Panels

Frequently Asked Questions About MRD Testing 

What is measurable residual disease (MRD)? 

Measurable residual disease (MRD), also called minimal residual disease, refers to the persistent small number of cancer cells that may remain after treatment even when a patient appears to be in remission. MRD testing uses highly sensitive technologies to detect residual malignant cells that are at levels below conventional clinical assessments.  

Why is MRD important in clinical trials? 

MRD is an increasingly important biomarker because lower MRD levels have been associated with improved clinical outcomes and reduced risk of relapse. MRD assessments can help sponsors and clinicians evaluate treatment effectiveness, monitor disease burden over time, estimate relapse risk, and strengthen interpretation of clinical response endpoints.  

What technologies are used for MRD testing? 

MRD can be assessed using several highly sensitive analytical approaches, including multiparameter flow cytometry (MFC), next-generation sequencing (NGS), and PCR-based methods (dPCR, qPCR). The optimal method depends on the disease indication, study objectives, sample availability, and desired level of sensitivity.  

What are the advantages of flow cytometry-based MRD testing? 

Flow cytometry-based MRD testing provides direct characterization of residual tumor cells while simultaneously evaluating antigen expression patterns and immune cell populations. It is applicable to nearly all patients, has a fast turnaround time, and allows assessment of bone marrow hemodilution. This approach can help identify treatment-resistant or antigen-loss variants and supports monitoring across a broad range of hematologic malignancies. [CLL, AML] 

Which hematologic malignancies can be monitored using MRD assays? 

Navigate offers off-the-shelf flow cytometry-based MRD solutions for multiple blood cancers, including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL). Additional customized approaches for multiple myeloma, other lymphomas with bone marrow or peripheral blood involvement, and myelodysplastic syndromes (MDS) may be available depending on study requirements.  

How can MRD testing support CAR-T and other cell therapy programs? 

MRD testing can provide highly sensitive assessments of disease burden following cell therapy and may help sponsors and clinicians to understand depth of response beyond standard clinical response criteria. In cell therapy studies, MRD data can be used alongside pharmacodynamic and immune monitoring endpoints to better understand therapeutic efficacy and durability of response.  

When should MRD assessments be incorporated into a clinical trial? 

MRD testing can be incorporated at baseline, during treatment, at defined response assessment milestones, and throughout long-term follow-up. Strategic MRD sampling may help characterize depth of response, evaluate treatment kinetics, monitor for emerging relapse, and support clinical development decisions across the trial lifecycle 

Can MRD testing help predict disease relapse? 

Yes. MRD is widely recognized as a powerful indicator of residual disease burden and relapse risk in many hematologic malignancies. Detecting MRD following treatment may help identify patients at increased risk of relapse before clinical symptoms or morphological and standard diagnostic methods identify disease recurrence, enabling more informed patient management strategies.  

Why choose Navigate BioPharma for MRD testing services? 

Navigate BioPharma brings a high level of scientific and technical expertise in immunology, hematopoiesis, flow cytometry, and biomarker assay development to support MRD tests for clinical trials and translation research. With advanced flow cytometry capabilities, validated clinical trial workflows, and centralized expert data interpretation, our team provides MRD testing solutions designed to generate reliable, actionable data for biomarker-driven drug development. 

How does MRD testing complement immune profiling? 

MRD testing measures residual tumor burden, while immune profiling evaluates the immune system's status, activation, reconstitution, and response to therapy. Together, these approaches can provide a more complete understanding of treatment efficacy, mechanism of action, patient stratification, relapse risk, and long-term outcomes in oncology and immunotherapy studies.    

Immunogenicity Assays

Immunogenicity assays are complex and integral to biologic treatment development. We have the solutions you need for immunogenicity testing from pre-clinical through clinical development.