CAT #: MyMRD
MyMRD® NGS Panel – CLIA
- Description of Test:
The MyMRD® is a hotspot panel that detects all classes of variants identified in a precisely defined set of targets that commonly drive myeloid malignancies including AML, MPN and MDS. It can detect SNV, indels and translocations to the genomic basepair, giving unparalleled precision and detection of low level mutations in patients. Testing with MyMRD® allows for studying important mutations in known genes implicated in the causation, prognosis, and reoccurrence of myeloid disorders.
Minimal residual disease (MRD) detection has proven to be useful in the clinical management of patients with leukemia and can facilitate the development of new therapies. Patients with myeloid neoplasms are typically divided into different prognostic groups based upon both cytogenetics and traditional molecular profiles1; however, this may not reflect the heterogeneity of disease2 that can be exploited using MRD assessment.
Cancer heterogeneity poses several challenges to monitor MRD in patients. Additionally, patient sample is usually very limited, and therefore, serial testing is many times not a viable option. Thus, the development of a sensitive and reliable assay to detect several mutations within one sample represents a significant advancement in guiding treatment decisions. With the MyMRD® assay, one sample is enough to characterize at least one driving mutation in 90%-95% of all AMLs.
With one sample, you can characterize 90% of the driving mutations in AML, MPN and MDS.
Indexed whole genome libraries are hybridized with MyMRD® probes targeting mutation hotspots in a total of 23 genes (ASXL1 BRAF CALR CEBPA CSF3R DNMT3A FLT3 IDH1 IDH2 JAK2 KIT KRAS MPL NPM1 NRAS PTPN11 RUNX1 SF3B1 SRSF2 TP53 ZRSR2 CBFB-MYH11 KMT2A RUNX1-RUNX1T1). In addition to targeting single nucleotide variants (SNVs) and indels in the first 21 genes, 5 structural variant breakpoints within the final 3 genes are also targeted. Coupling comprehensive gene coverage with enhanced depth of coverage, long read lengths, and the power of our robust MyInformatics™ annotation software and bioinformatics database, MyMRD® confidently and reproducibly detects mutations with a mutant allele frequency of 5 x 10-3, while some mutations, such as FLT3 ITDs, are detected at mutation allele frequencies as low at 1 x 10-3.
SNV and Indel Targets in 23 Genes (Exons)
ASXL1 BRAF CALR CEBPA CSF3R DNMT3A FLT3 IDH1 IDH2 JAK2 KIT KMT2AKRAS MPL MYH11NPM1 NRAS PTPN11 RUNX1 SF3B1 SRSF2 TP53 ZRSR2
Structural Variants (Translocations and Partial Tandem Duplications in Intronic Structures) (5 targets)
CBFB-MYH11 KMT2A RUNX1-RUNX1T1
- Indications for Testing:
- Acute myeloid leukemia (AML)
- Myelodysplastic syndrome (MDS)
- Myeloproliferative neoplasms (MPN)
- Turnaround Time:7-14 Business Days
- CPT Codes:
- Specimen Requirements:
- 1-3mL of Peripheral Blood, NAHeparin, EDTA or ACD
- 0.25-1mL of bone marrow in NaHeparin, EDTA or ACD
- 1 ug of purified, high quality genomic DNA
- A completed Test Requisition Form, including patient consent signature, must be submitted with each sample.
- Specimen Storage Conditions:
2-8 C for up to 7 days prior to testing
- Specimen Shipping Conditions:
- Peripheral blood or bone marrow: Ambient or cool. Do not freeze.
- Isolated DNA: Ambient or frozen on dry ice.
- Locations Where Test is Performed:
- San Diego, California, USA – LabPMM, LLC
- Martinsried, Germany – LabPMM GmbH
- Arber, D.A. et al. (2016). The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood, 127(20), 2391-2405.
- 2. Sperling, A.S. et al. (2017). The genetics of myelodysplastic syndrome: from clonal hematopoiesis to secondary leukemia. Nature Reviews. Cancer, 17(1), 5–19