NGS Myeloid 37 Genes Panel

Minimum of 3 mL whole blood in a purple (EDTA) or pink top tube (EDTA); minimum of 1 mL of bone marrow aspirate in a purple, pink, or green (heparin) top tube.

This Core Myeloid panel is a 37 gene targeted sequencing panel for critical myeloid lineage neoplams, including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and myelodysplastic syndromes (MDS) markers. The genes on the myeloid panel are including ABL1, ANKRD26, ASXL1, BCOR, BRAF, CALR, CBL, CEBPA, CSF3R, DDX41, DNMT3A, ETNK1, ETV6, EZH2, FLT3, GATA1, GATA2, IDH1, IDH2, JAK2 (exon 12-16), KIT, KRAS, MPL, NPM1, NRAS, PHF6, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, STAG2, TET2, TP53, U2AF1, WT1, ZRSR2.

Clinical indication, copy of pathology report, and specimen source is required for the assay.

Refrigerated: 5 days; ambient (room temperature): 3 days; specimen must be received by laboratory within 7-days of collection.

Frozen specimen; clotted or grossly hemolyzed specimens; serum; specimens without 2 patient identifiers; serum or plasma, aliquots (previously open containers); specimen that were received >7-days after collection.

2 years DNA and raw data; whole blood and bone marrow - 1 week.

Only tissue that is clearly invasive carcinoma (established by histopathologic criteria) should be tested. Selection of tissue for the PCR assay should be performed by a pathologist. This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.