MRD Detection Development Services for CLL

Minimal residual disease (MRD) detection in chronic lymphocytic leukemia (CLL) is gaining significant attention in research, highlighting its potential for broader future clinical applications. Alfa Cytology specializes in developing highly sensitive MRD detection methodologies—including flow cytometry, next-generation sequencing (NGS), and PCR-based techniques (qPCR/dPCR)—to precisely quantify residual cancer cells in CLL patients post-treatment. Our goal is to accelerate the integration of MRD testing into routine clinical practice and validate its clinical utility as a critical prognostic indicator and tool for evaluating treatment response.

Introduction to MRD in Chronic Lymphocytic Leukemia

According to the International Workshop on CLL (iwCLL), patients achieving complete remission (CR) often harbor residual CLL cells. Even minimal levels of residual disease can signify an increased risk of relapse. Post-treatment MRD status is a powerful, independent predictor of outcomes for patients receiving chemotherapy, immunotherapy, or targeted therapies. However, MRD assessment presents greater technical complexity and higher costs compared to standard clinical evaluation. These challenges currently limit the routine adoption of MRD testing in clinical practice.

Fig. 1. Evolution and requirements for flow cytometry panels for MRD testing in CLL. (Benintende, G. et al., 2023)

We are committed to providing assay development services for CLL MRD. The heterogeneity, sensitivity, and lack of standardized procedures associated with CLL MRD assays make their utilization in the clinical setting challenging. Consequently, we specialize in offering tailored development services aimed at discovering novel assays that can effectively meet the specific requirements of researchers in this field.

Development of Flow Cytometry for MRD Detection in CLL

• Drawing upon the principles of multiparameter flow cytometry, we can develop antibody panels conjugated with different fluorescent dyes to identify specific CLL phenotypes and measure residual leukemia cells post-treatment. Our existing antibody panel includes CD19, CD20, CD38, CD22, CD43, CD79b, and CD81. If you require additional antibodies, we also offer customized services.
• We offer CLL MRD analysis using state-of-the-art flow cytometry techniques. We have enhanced the MRD panel to utilize two 6-color tubes, allowing for increased parameter acquisition, reduced time and sample requirements for MRD counting, and the ability to quantitatively detect residual disease.

Development of PCR-based method for MRD Detection in CLL

As CLL arises from the abnormal proliferation of a specific B-cell population, our developed PCR technology identifies each B-cell clone at the genetic level based on the unique rearrangement of immunoglobulin (Ig) genes within the hyper-variable region. Our service provides standardized analysis to enhance result comparability. The advantages of our developed PCR technology for CLL clone identification and MRD detection include its applicability to frozen samples, eliminating the need for processing fresh samples and simplifying result analysis.

Development of Next-Generation Sequencing for MRD Detection in CLL

Utilizing next-generation sequencing (NGS), we have developed a method for MRD detection, which serves as an important diagnostic tool for quantifying tumor burden. Our NGS technology identifies residual leukemia cells by amplifying all VDJ sequences within a single DNA sample. The NGS detection technique we have developed approaches a stable MRD5 detection limit, exhibiting extremely high sensitivity in detecting CLL MRD. It can detect MRD that may be undetectable by flow cytometry and PCR methods.

Advantages of Our Services

• Advanced flow cytometry techniques
• A variety of specific antibodies for detecting CLL
• Highly sensitive detection methods
• Customized development services

Alfa Cytology is committed to advancing MRD detection in CLL through our expertise, cutting-edge technologies, and customized services. Contact us to discuss how we can support your research or clinical endeavors in achieving more accurate and sensitive CLL MRD detection, ultimately improving patient outcomes.