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AML MRD Assay

Multiparametric Flow Cytometry

Clinical Information
The 12-color AML MRD Assay provides a comprehensive
approach to evaluate bone marrow and peripheral blood
samples for the presence or absence of measurable (minimal)
residual disease (MRD) in patients treated for acute myeloid
leukemia (AML).
12-color multiparametric flow cytometry (MFC) is a state of theart method for MRD assessment that it is highly sensitive andspecific. Using a comprehensive selection of antibodies and astandardized panel across all testing points, MRD populations
can be characterized and tracked down to 0.01%. Use of up to
12 biomarkers per tube, allows identification of more leukemia
associated immunophenotypes (LAIPS) with less sample thanpreviously available. A panel of 21 antibody markers is used
to characterize potential AML blast cells using a LAIP based
different from normal (DfN) approach for MRD identification.
If available, information from diagnosis is used, although theassay can identify aberrant cells that have diverged from normal
maturation without previous patient history.
In addition to MRD monitoring, this panel’s extensive biomarker
selection may be used to enroll and monitor subjects in clinicaltrials, thereby accelerating drug approvals. Interpretation
subjectivity is minimized through standardized analysis software
powered by state-of-the-art AI decision support technology andmachine learning (ML).

Biomarkers in the AML MRD Assay
CD2

CD4

CD5

CD7

CD11b

CD13

CD14

CD15

CD16

CD19

CD33

CD34

CD36

CD38

CD45

CD56

CD64

CD117

CD123

HLA-DR7AAD

Key Points
12-Color Panel of 21 Biomarkers
Provides up to 0.01% Sensitivity and high Specificity withless sample
LAIP based DfN approach for MRD identification
Globally standardized Testing through LabPMM Network
Multiparametric Flow Cytometry and NGS Testing Available
Accurate results comparisons using a primary sample

Indications for Testing
Monitor and evaluate for disease relapse and recurrence
Enroll and monitor subjects in clinical trials
Identify tumor-specific markers for post-treatment monitoring

Interpretation

An interpretive report will
indicate the presence/absenceof AML MRD in relation to theclinical cutoff of 0.1%. When
MRD is detected, the associatedimmunophenotypic profile will be
described.

2018 ELN MRD Working Party Consensus2, 2006 Bethesda
Consensus5 and 2017 WHO Classification Guidance6
Enhanced analyses using artificial intelligence (AI) andmachine learning (ML)

Turnaround
TimeSpecimen
Requirements

ShippingConditions

24 hours

2 mL of bonemarrow in EDTA or
Sodium Heparin

Ambient or Cool;
Do not freeze

Sample Stability

Store specimens
at 2-8°C; must be
received by lab within
72 hours after draw

2-4 mL of peripheral
blood in EDTA or
Sodium Heparin

San Diego, USA | Munich, DE | Kawasaki, JP | Shanghai, CNM-0063 Rev04 | June 2024

a.

b.

c.

d.

e.

f.

a. After initial quality assessment of stable flow of acquisition , exclusion of doublets, non-viable cells, RBCs, and debris, live cells are
gated based on CD45 vs. side scatter (SSC). CD45 is a pan leukocyte marker that helps presumptive separation of WBC populationin relation to SSC with likely populations (blue-lymphocytes, gray –monocytes, green- granulocytes, red-blasts/progenitors, andother rare events, yellow-erythroid, megakaryocytic and other CD45 neg events including debris). Dot plots are created using
the Boolean gate strategy (off the CD45 pos events). b. A clean CD45 dim gate is used to remove lymphocytes and other cellcontamination from CD45 dim (blasts/progenitor) gate. Blasts often have a higher FSC/SSC than lymphocytes (blue). c. Back gating
to identify CD117 positive cells on CD45/SSC plot. Blast % is assessed based on clean dim CD45 gate. Similar strategy is also usedfor CD34 pos cells. d. Aberrant myeloblast population identified based on DfN open gates, CD117 pos/CD34 negative. AML MRD
population (LAIP) is gated by choosing combinations that make aberrant populations prominent and trackable across the tube(pink). e. Aberrant myeloblasts are CD34 neg/HLA-DR pos (pink) f. Aberrant myeloblasts are CD34 neg/CD38 pos (pink).

References
1. BL Wood. Curr Protoc in Cytom. 93(1), e73 (2020). 2. GL Schuurhuis et al. Blood 131(12):1275-1291 (2018). 3. J Cloos. et al. J of Vis. Exp: JoVE. (133) (2018). 4. N Feller et al. Blood Cancer J. 3(8): e129-e129(2013). 5. BL Wood et al. Cytometry B: Clin Cytom. 72(S1), S14-S22 (2007). 6. SH Swerdlow et al., WHO Classification of Tumours, (Revised 4th Edition) IARC: Lyon, 421 (2017). 7. M Stetler-Stevenson.
Clinical and Laboratory Standards Institute (2007).

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