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This handout provides an overview of what MRD is, the role of MRD testing in care, and information about insurance coverage for MRD testing.
"Assessment of measurable residual disease (MRD) is rapidly transforming the therapeutic and prognostic landscape of a wide range of hematological malignancies. Its prognostic value in acute lymphoblastic leukemia (ALL) has been established and MRD measured at the end of induction is increasingly used to guide further therapy. Although MRD detectable immediately before allogeneic hematopoietic cell transplantation (HCT) is known to be associated with poor outcomes, it is unclear if or to what extent this differs with different types of conditioning."
"Ten of 36 patients (28%) achieved an OS ?30 months in a blinatumomab study in relapsed/refractory acute lymphoblastic leukemia. Long-term survival may be associated with T-cell expansion, B-cell depletion, and a minimal residual disease response."
"The guideline provides a framework for the multiple steps, including laboratory testing, in the evaluation of acute leukemia samples. Some aspects of the guideline, especially molecular genetic testing in acute leukemia, are rapidly changing with new supportive literature, which will require on-going updates for the guideline to remain relevant."
"The ASCO Expert Panel determined that the recommendations from the guideline, published in 2016, are clear, thorough, and based on the most relevant scientific evidence. ASCO fully endorsed the CAP-ASH guideline on initial diagnostic work-up of AL and included some discussion points according to clinical practice and updated literature."
"This article presents an approach to MRD detection in B-LL/L by flow cytometry through case presentations with illustration of several potential pitfalls."
"BCR-ABL1�positive cells outside the B-lineage compartment are found in 40% of adult patients with BCR-ABL1�positive BCP-ALL. Selection of preexisting CD19� subclones is a potential source of tumor escape after CD19-targeted therapies in adult Philadelphia chromosome�positive ALL."
"In both children and adults with ALL, MRD testing as early as induction therapy has been shown to have prognostic significance."
"Authors identified genetic mutations in�CD19�and loss of heterozygosity at the time of CD19��relapse to chimeric antigen receptor (CAR) therapy."
"In a multicenter study, MRD was measured prospectively on 598 follow-up bone marrow samples from 102 high-risk children and 136 adult ALL patients, using IG/TCR-QPCR and 4/5 color MFC."
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"The following is a list of facilities that are CLIA-certified and accept external MRD samples. Amgen neither recommends nor endorses, and may or may not have financial relationships with, any facility that appears on this list. This list is not intended to be a comprehensive list nor as a referral to any provider listed. If you would like to suggest a facility to be added to this list, please contact Amgen MedInfo at 800-77-AMGEN."
"Studies have demonstrated that achievement of MRD negativity after induction chemotherapy or during consolidation is associated with significantly better long-term outcomes, and MRD status constitutes an independently prognostic marker, often superseding other conventional risk factors."
"Here, the EuroClonality (BIOMED-2) consortium summarizes important pre- and post-analytical aspects of clonality testing, provides guidelines for interpretation of clonality testing results, and presents a uniform way to report the results of the Ig/TCR assays."
This websites provides key elements of an evaluation plan, which can help guide your evaluation efforts.
"In adults with relapsed/refractory ALL receiving first salvage therapy, achievement of MRD negativity is an important therapeutic outcome. Patients who achieve MRD negativity with first salvage treatment and undergo SCT have the best long-term survival."
"The persistence of MRD during therapy is the strongest adverse prognostic factor in ALL. We developed a high-throughput sequencing method that universally amplifies antigen-receptor gene segments and identifies all clonal gene rearrangements (i.e., leukemia-specific sequences) at diagnosis, allowing monitoring of disease progression and clonal evolution during therapy."