Enabling discoveries in biopharma

AML-MRD-SEQ Panel

Ultra-sensitive liquid biopsy solution for the detection of established and emerging gene mutations associated with Acute Myeloid Leukemia (AML)

By offering reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus pan-heme NGS tests, Sysmex-Inostics’ AML-MRD-SEQ can accelerate clinical development of novel therapeutics leading to more reliable information on which to base important decisions for AML patients.1,2,3

AML-MRD-SEQ is CLIA-validated and joins the portfolio of ultra-sensitive Plasma-Safe-SeqS tests available through Sysmex Inostics’ CLIA lab service in Baltimore, MD.

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  • AML is one of the deadliest blood cancers that takes more than 10,000 lives in the U.S. each year. If cancer relapses after treatment, the prognosis is typically poor. Therefore, after initial treatment, patients are tested for MRD as a prognostic indicator of therapeutic effectiveness and relapse risk.
  • Plasma-Safe-SeqS AML-MRD-SEQ provides additional information across other AML genes which may be relevant for MRD detection.4

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Clinical Revelance

Complex clonal dynamics of AML demand coverage across more genomic regions than current digital PCR methods are able to interrogate. However, current NGS pan-heme panels lack sufficient sensitivity for reliable detection of MRD, as their limits of detection are between 1-5% mutant allele frequency (MAF).

  • The AML-MRD-SEQ Panel demonstrates ultra-sensitive detection of low frequency mutations, with a calling threshold of 7 MM (0.035% MAF for 20,000 GE DNA input), with high specificity. This represents a sensitivity improvement over pan-heme NGS tests of ~50 -100 X.2,3
  • AML-MRD-SEQ achieves increased, yet targeted, genomic coverage. The assay also interrogates other clinically relevant markers to evaluate the association between detection with unparalleled sensitivity and clinical outcomes.

The presence or absence of MRD in AML patients has emerged as an important tool for improving patient management and outcomes by enabling:

  • Refined risk classification
  • More robust post-transplant surveillance
  • Accelerated therapeutic development as a surrogate endpoint

Enabling discoveries in biopharma

By offering reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus pan-heme NGS tests, AML-MRD-SEQ can accelerate clinical development of novel therapeutics leading to more reliable information on which to base important decisions for AML patients.

AML-MRD-SEQ Panel covers mutations with established and emerging value across different therapeutic modalities

Get the latest on AML-MRD-SEQ, download now:

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References

  1. Duchstein, L. et al. (2020) Ultrasensitive measurable residual disease (MRD) detection in acute myeloid leukemia (AML) using a targeted next generation sequencing (NGS) panel [abstract]. In: 62nd American Society of Hematology Annual Meeting and Exposition; December 5-8; ASH. Abstract nr 1078.
  2. https://www.illumina.com/content/dam/illumina-marketing/documents/products/datasheets/datasheet-trusight-myeloid.pdf
  3. https://assets.ctfassets.net/w98cd481qyp0/42r1cTE8VR4137CaHrsaen/baf91080cb3d78a52ada10c6358fa130/FoundationOne_Heme_Technical_Specifications.pdf
  4. US Food & Drug Administration. Hematologic Malignancies: Regulatory Considerations for User of Minimal Residual Disease in Development of Drug and Biological Products for Treatment. January 2020.