MRD assessment

The level of minimal residual disease (MRD) is paramount to link the depth of response and long-term outcome. Some patients that reach complete response (CR) have inferior progression free survival (PFS) which is due to positive minimal residual disease which will sooner or later provoke a relapse. The recent advances in treatment demand a more sensitive response criteria which includes minimal residual disease evaluation.

MRD has been defined as one of the best surrogate markers to predict overall survival (OS) and accelerate the approval of new therapies. The European Medicines Agency (EMA) and FDA have published guideline drafts to use MRD as clinical endpoint.

Cytognos developed solutions for the post-treatment monitoring of plasma cell dyscrasias and B-cell precursor acute leukemia.

Monitoring of Plasma Cell Dyscrasias

The EuroFlow™ approach for the study of Multiple Myeloma samples by Next Generation Flow™ can be used both for monitoring of Circulating Tumor Plasma Cells (CTPC) at diagnosis and Multiple Myeloma MRD (MM MRD) assessment after treatment. Our kits used together with standardized protocols for sample processing, staining and acquisition of a high number of events have been designed to provide fast, ultrasensitive, and accurate results following the recommendations of the EuroFlow™ consortium and the requirements of FDA and EMA for clinical trials.

*The CD138 and CD27 antibodies selected by EuroFlow™ must be added as “drop-in” antibodies.

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Read more about Cytognos Solutions for plasma cell dyscrasias evaluation.

Monitoring B-Cell Precursor Acute Lymphoblastic Leukemia

• Follow-up and sensitive quantification of MRD in BCP-ALL patients. MRD evaluation is one of the most significant prognostic factors in ALL for predicting disease recurrence.
• Consistent panel of antibodies and fluorochromes:
  • Backbone markers for the evaluation of the B-cell maturation pathway. Evaluate the potential of the flow assay to detect normal BM cells that are regenerating after chemotherapy to reduce likelihood that those cells are misinterpreted as abnormal cells.
  • CD66c, CD123, CD73 and CD304 markers to define frequent abnormalities in BCP-ALL.
• Suitable for evaluation of bone marrow, which is the most appropriate sample for BCP-ALL-MRD evaluation.
• Pre-determined MRD thresholds for accurate reporting based on LOD and LLOQ and number of acquired events. Lower Limit of Detection and Limit of Quantitation should be reported after analysis in order to provide an objective result following current reporting guidelines.
• High sensitivity close to 10-5.
• Applicable in virtually all BCP-ALL samples since no specific primers or probes are required.
• Evaluate efficacy of treatment and individualized therapy monitoring by evaluation of the tumor load.

Read more about Cytognos Solutions for acute leukemia.