CAT #: CLL-MRD-MFC

CLL MRD Assay by Multiparametric Flow Cytometry

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  • 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 populations.3  While clinical remission (CR) has been the standard goal of end-of-treatment response for decades, updated understanding of prognosis as well as novel treatment strategies that can achieve deeper levels of remission now necessitate newer, more sensitive, and standardized assessments of treatment response, such as measurable (or minimal) residual disease (MRD) assessments.4,5

    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.

    Our CLL MRD Assay by MFC is a streamlined and targeted 11-color panel designed to characterize potential CLL cells with clear separation from other B-lineage cells.4,7,8 The assay is validated on bone marrow and peripheral blood samples to detect the presence or absence of CLL MRD in patients at any stage of treatment, including targeted immunotherapies. Using a standardized panel across all time points, MRD populations can be characterized and tracked to 0.005% sensitivity. The technical component of the assay will be performed in our clinical laboratories, and the interpretation will be performed by our team of expert hematopathologists.

    If available, information from diagnosis will be used to assist with the assessment, although the assay can identify aberrant cells that have diverged from normal populations without previous patient history or baseline assessment.

  • Overview:

    CLL MRD Assay biomarkers

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References

  1.   Y Dong et al. Exp Hematol Oncol.  2020; 9:14. https://doi.org/10.1186/s40164-020-00170-6
  2.   Y Ou et al. Frontiers in Oncology.  2022; 84:6-16.  https://doi.org/10.3389/fonc.2022.840616
  3.   Batista, JL et al. (2017). Pathology and Epidemiology of Cancer.  Springer, Cham.  https://doi.org/10.1007/978-3-319-35153-7_29
  4.   JR Cerhan and SL Slager SL. Blood.  2015;126(20):2265–73.
  5.   Y Yao et al. BioMedical Engineering. 2022;21, 4. https://doi.org/10.1186/s12938-021-00973-6
  6.   WG Wierda et al. Leukemia.  2021; 35: 3059–3072.  https://doi.org/10.1038/s41375-021-01241-1
  7.   M Hallek and O Al-Sawaf. Am J Hematol.  2021; 96( 12):1679- 1705.  doi:10.1002/ajh.26367
  8.   A Rawstron A et al. Blood.  2018;132(Suppl 1):S181.
  9.   MM Sartor et al. Cytometry Part B.  2013; 84B:96–103.
  10.   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.
  11.   AC Rawstron et al. Leukemia.  2013 Jan;27(1):142-9.  doi: 10.1038/leu.2012.216. Epub 2012 Jul 31. PMID: 23041722.

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