AML MRD Assay Multiparametric Flow Cytometry

• Description of Test:

  Measurable residual disease, also called “minimal residual disease” (MRD) refers to persistent leukemic cells in the blood or bone marrow of cancer patients during or after treatment. Undetected or untreated MRD is a major cause of cancer recurrence, hence sensitive MRD tests are needed to guide optimal treatment programs and provide prognostic indicators for risk stratification of patients.

  Flow cytometry has long been the standard of care for many blood cancers including acute myeloid leukemia (AML), but to achieve MRD level sensitivity with limited sample, powerful 12-color multiparametric flow cytometry (MFC) is needed. MFC is a state of the art method of MRD assessment that is widely used because it is highly sensitive, fast and cost-effective. The AML MRD Assay uses a comprehensive panel of antibody markers to characterize potential AML blast cells using a leukemia associated immunophenotype (LAIP) based different from normal (DfN) approach. This approach takes into account information from diagnosis, if available but also identifies aberrant cells that have differentiated from normal maturation without previous patient history. Use of up to 12-colors per tube enables the identification of more LAIPs using less sample previously available. Using a comprehensive selection of antibodies and a standardized panel across all time points, MRD populations can be characterized and tracked down to 0.01% sensitivity. 

  This MRD panel not only provides evaluation and monitoring of patients with hematological malignancy but provides a wide array of applications due to its comprehensive biomarker selection.

• Overview:

  Biomarkers in the AML MRD Assay

  CD2, CD4, CD5, CD7, CD11b, CD13, CD14, CD15, CD16, CD19, CD33, CD34, CD36, CD38, CD45, CD 56, CD64, CD117, CD123, HLADR, 7AAD

Service Details

• Indications for Testing:
  • Identify tumor-specific markers for post-treatment monitoring
  • Clinical trial enrollment and surrogate endpoint in trials
  • Monitor and evaluate for disease relapse and recurrence
  • Monitor response to therapy
• Specimen Storage Conditions:

  

• Locations Where Test is Performed:
  • USA – LabPMM LLC
  • Germany – LabPMM GmbH
  • China – Invivoscribe Tech