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Pre-Transplant MRD Testing That Supports Long-Term Success

Measurable Residual Disease (MRD) is a powerful predictor of relapse and survival in patients with Acute Myeloid Leukemia (AML).1,2,3  For bone marrow transplant centers, MRD assessment prior to allogeneic hematopoietic cell transplantation is essential for identifying patients at high risk and optimizing pre- and post-transplant strategies.4*

LabPMM® Clinical Services are powered by Invivoscribe® assays, delivered through our globally harmonized network and offer a comprehensive suite of AML MRD testing services that enable highly sensitive and actionable pre-transplant assessments.

FLT3 ITD MRD Assay by NGS

INDICATIONS FOR TESTING

  • Stratifying risk for AML
     recurrence
  • Monitor internal tandem
    duplications (ITDs) in the
    FLT3 gene and evaluate for disease recurrence

RESULT TUNRAROUND 
  • 7 - 10 business days

SENSITIVITY

  • 5 x 10-5

SPECIMEN

  • Peripheral blood         
  • Bone marrow
FLT3-ITD-service-summary
FLT3 ITD Graph
Linearity
DNA from two cell lines with known FLT3 ITD mutations (30 bp and 126 bp, respectively) were serially diluted into background DNA from a wild-type FLT3 cell line and tested with the FLT3 ITD MRD Assay.  Input DNA quantity was 700 ng per dilution point.  Assay linearity has an R2 < 0.975 for the mutation to total read ratio in the range of 10-2 to 10-5.
FLT3 ITD MRD Sensitivity
Sensitivity and Specificity
This table shows that the assay sensitivity is >95% for both small (30 bp) and large (126 bp) size ITDs.  In addition, no false positives were identified in any negative samples (cell line C) nor were any unexpected ITDs observed in any of the positive samples, indicating a very high specificity and positive predictive agreement for the assay.
FLT3-ITD-service-flyer
Click the image to view the FLT3 ITD MRD Assay by NGS flyer.

NPM1 MRD Assay by NGS

NPM1-MRD-summary-1
NPM1 Graph

Linearity
DNA from a cell line containing an NPM1 mutation (4 bp insertion) was serially diluted into DNA from a wild-type NPM1 cell line and tested with the NPM1 MRD Assay.  Input DNA quantity was 700 ng per dilution point.  Assay linearity has an R2  < 0.980 for the expected vs. detected mutation in the range of 1E-02 to 1E-05.

NPM1 Sensitivity

Sensitivity and Specificity
The sensitivity and specificity of the NPM1   MRD Assay was demonstrated by testing 20 NPM1 positive clinical samples, further diluted into DNA from healthy peripheral blood to two levels, 1.0% and 0.1%, and 10 healthy peripheral blood samples.  This table shows that the assay agreement is 98%. In addition, no false positives were identified in any negative samples nor controls, indicating a very high specificity and positive predictive agreement for the assay.

NPM1-MRD-service-flyer
Click the image to view the NPM1 MRD Assay by NGS flyer.
INDICATIONS FOR TESTING
  • Identify tumor-specific
    markers for post-          treatment monitoring
  • Monitor and evaluate for disease recurrence
RESULT TUNRAROUND 
  • 7 - 10 business days
SENSITIVITY   
  • 5 x 10-5
SPECIMEN
  • Peripheral blood 
  • Bone marrow

 

 

 

AML MRD Assay by MFC

INDICATIONS FOR TESTING

  • Monitor and evaluate for
    disease recurrence          
  • Enroll and monitor                    Subjects in clinical trials 
  • Identify tumor-specific
    markers for post-treatment
    monitoring
RESULT TURNAROUND
  • 24 hours
SENSITIVITY
  • 0.01%

SPECIMEN

  •  Peripheral blood 
  • Bone marrow
AML-MRD-by-MFC-summary
AML MRD Assay by MFC biomarkers
Biomarker Panel
The AML MRD Assay by MFC achieves MRD level sensitivity with limited sample by using a powerful 12-color multiparametric flow cytometry panel containing 21 biomarkers.
AML-MRD-MFC-flyer
Click the image to view the AML MRD Assay by MFC flyer.
References
1. Dillon et al. (2023). JAMA. 329(9):745-755.
2. Dillon et al. (2024). JAMA Onc. 10(8):1104-1110.
3. Levis et al. (2025). Blood. 145(19): 2138–2148.
4. Heuser et al. (2021). Blood. Dec 30; 138(26):2753-2767.

 

Disclaimers
The NPM1 MRD Assay and FLT3 ITD MRD Assay clinical services are available through the LabPMM Global Network, a CAP-accredited / CLIA-certified laboratory (in regions where recognized).
*To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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