Plasma-Safe-SeqS Panel
AML-MRD-SEQ
The AML-MRD-SEQ panel is a liquid biopsy solution for the identification of gene mutations, associated with Acute Myeloid Leukemia (AML) Measurable Residual Disease (MRD).
The Plasma-Safe-SeqS AML MRD Panel demonstrates ultra-sensitive detection of low frequency mutations, with a calling threshold of 5 MM (0.025% MAF for 20,000 GE DNA input), while specificity remains very high. This represents a sensitivity improvement over pan-heme NGS tests of ~50 -100 X. Like other Plasma-Safe-SeqS platform configurations, it has been observed 100% overall agreement with the OncoBEAM IDH1 orthogonal method for detection of IDH1 mutations in clinical samples. Plasma-Safe-SeqS AML MRD also provides additional information across other AML genes which may be relevant for MRD detection.
The AML-MRD-SEQ Panel demonstrates ultra-sensitive detection of low frequency mutations, with a calling threshold of 5 MM (0.025% MAF for 20,000 GE DNA input), while specificity remains very high. This represents a sensitivity improvement over pan-heme NGS tests of ~50 -100 X.1,2
Like other Plasma-Safe-SeqS platform configurations, it has been observed 100% overall agreement with the OncoBEAM IDH1 orthogonal method for detection of IDH1 mutations in clinical samples. AML-MRD-SEQ also provides additional information across other AML genes which may be relevant for MRD detection.3
Clinical Relevance
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.
AML-MRD-SEQ Panel covers mutations with established and emerging value across different therapeutic modalities
This chart illustrates the following details about the Plasma-Safe-SeqS AML MRD Panel. The Plasma-Safe-SeqS AML MRD Panel covers mutations with established and emerging value across different therapeutic modalities.
References
- https://www.illumina.com/content/dam/illumina-marketing/documents/products/datasheets/datasheet-trusight-myeloid.pdf
- https://assets.ctfassets.net/w98cd481qyp0/42r1cTE8VR4137CaHrsaen/baf91080cb3d78a52ada10c6358fa130/FoundationOne_Heme_Technical_Specifications.pdf
- 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.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hematologic-malignancies-regulatory-considerations-use-minimal-residual-disease-development-drug-and
