The My Heme (myeloid) Panel is a Next-Generation Sequencing (NGS) test which determines mutation status of recurrently mutated genes that play an important role in the diagnosis, prognosis and clinical management of patients with myeloid neoplasms, including Acute Myeloid Leukemia (AML), MyeloDysplastic Syndrome (MDS), MyeloProliferative Neoplasm (MPN) and MDS/MPN. In addition, with the emergent clinical relevance of Clonal Cytopenia of Undermined Significance (CCUS), this NGS panel serves as a useful ancillary test in the initial evaluation of patients with cytopenia. This assay provides clinically relevant, myeloid-related molecular profiles from hematologic samples of patients in a timely and accurate fashion for clinicians and pathologists. Results generated from this assay can be integrated into routine clinical practice.
A minimum of 1 milliliter of fresh peripheral blood or bone marrow aspirate collected in a lavender-top EthyleneDiamineTetraacetic Acid (EDTA) tube
My Heme Panel was developed and tested in the Weill Cornell Medicine Molecular Hematopathology Laboratory. My Heme Panel has not been approved by the Food and Drug Administration (FDA). The FDA has determined that such approval is not necessary. Absence of detection of a genetic alteration with this assay implies that it is not identified within the detection limit of the assay and does not necessarily rule out its absence in the specimen. Variants of low frequency, including subclonal mutations, may escape detection in this assay when the coverage depth is relatively low. High-prevalence germ line alterations (e.g, germ line polymorphisms with population allele frequency of greater than 1 percent) are not reported. Although My Heme Panel may identify some low-prevalence germ line alterations, this tumor-only, NGS assay is primarily designed to detect recurrent somatic mutations associated with myeloid disorders. If a possible pathogenic (inherited) germ line mutation is suspected, separate clinical germ line testing and counseling from a board-certified genetic counselor will be recommended.