CAT #: CLLMRD
CLL MRD Assay for Multiparametric Flow CytometryCONTACT US ⟶
Description of Test:
The global burden of chronic lymphocytic leukemia (CLL) has increased over the past 30 years by approximately 7%, with a higher incidence among men and adults over 65.1,2 Moreover, CLL is the most prevalent type of leukemia, comprising of 25% – 30% of all leukemias in Western populations3, indicating potential heredity.4,5 However, medicine has also progressed to characterize the disease, leading to new treatment strategies, including targeted inhibitors—these require a sensitive, objective confirmation of treatment response6,7, commonly referred to as measurable (or minimal) residual disease (MRD).
MRD is a sensitive indicator of disease burden during and after fixed-duration treatment and has been correlated with progression free survival (PFS) and overall survival (OS)8 and is an independent prognostic indicator in patients with CLL. While flow cytometry has long been the standard of care for management of many blood cancers including CLL, achieving MRD-level sensitivity for detection of disease with limited sample requires a technique with higher level of complexity, such as multiparametric flow cytometry (MFC). MFC is a state-of-the-art method for MRD assessment that is widely used because it is highly sensitive, fast and cost-effective.
The MFC-based CLL MRD Assay is a CAP-validated service provided by the LabPMM Global Network. This MRD assay is an extensive 11-color MFC panel targeting CLL-specific biomarkers designed to characterize potential CLL cells with clear separation from other B-lineage cells. In addition to characterizing CLL disease, the CLL MRD Assay provides an array of applications and features, some of which include:
- Using a standardized panel across all time points, MRD populations can be characterized and tracked to 0.005% sensitivity
- Alignment with International Harmonized Approach9,10,11 and ERIC protocol10,11
- Designed to work with Peripheral Blood and Bone Marrow specimens
- Optimize shared/limited samples by co-testing with MFC and NGS
Biomarkers in the CLL MRD Assay:
CD81, CD79b, CD22, CD19, CD43, CD200, CD20, CD5, CD3, CD40, 7AAD, CD38
Indications for Testing:
- Identify tumor-specific immunophenotypes for post-treatment monitoring and evaluation for relapse
- Stratify patient risk and streamline clinical trial enrollment
- Use as a potential surrogate endpoint in clinical trials
- Specimen Requirements:
Locations Where Test is Performed:
- USA – LabPMM LLC
- Germany – LabPMM GmbH
- China – Invivoscribe Technologies
Please contact Invivoscribe, Inc. for more information.
- Y Dong et al. Exp Hematol Oncol. 2020; 9:14. https://doi.org/10.1186/s40164-020-00170-6
- Y Ou et al. Frontiers in Oncology. 2022; 84:6-16. https://doi.org/10.3389/fonc.2022.840616
- Batista, JL et al. (2017). Pathology and Epidemiology of Cancer. Springer, Cham. https://doi.org/10.1007/978-3-319-35153-7_29
- JR Cerhan and SL Slager SL. Blood. 2015;126(20):2265–73.
- Y Yao et al. BioMedical Engineering. 2022;21, 4. https://doi.org/10.1186/s12938-021-00973-6
- WG Wierda et al. Leukemia. 2021; 35: 3059–3072. https://doi.org/10.1038/s41375-021-01241-1
- M Hallek and O Al-Sawaf. Am J Hematol. 2021; 96( 12):1679- 1705. doi:10.1002/ajh.26367
- A Rawstron A et al. Blood. 2018;132(Suppl 1):S181.
- MM Sartor et al. Cytometry Part B. 2013; 84B:96–103.
- AC Rawstron et al. Leukemia. 2016; Apr;30(4):929-36. doi: 10.1038/leu.2015.313. Epub 2015 Dec 7. PMID: 26639181; PMCID: PMC4832072.
- AC Rawstron et al. Leukemia. 2013 Jan;27(1):142-9. doi: 10.1038/leu.2012.216. Epub 2012 Jul 31. PMID: 23041722.