NPM1 by PCR

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.

Mutations in NPM1 gene have been used as indicators for risk stratification on prognosis for cytogenetically normal acute myeloid leukemia (CN-AML).

The Nucleophosmin (NPM1) gene is one of the most commonly mutated genes in acute myeloid leukemia (AML), occurring in about 35% of AML patients at diagnosis and 60% of adult cytogenetically normal AML (CN-AML). The vast majority of NPM1 mutations are insertions in exon 12 occurring near the C-terminus of the protein resulting in cytoplasmic localization. NPM1 insertion mutations, in conjunction with a normal karyotype and the absence of the FLT3 mutation, are associated with a good response to induction chemotherapy and have a 60% improved 5 year survival.

Copy of the referring client's requisition form to accompany specimen.

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); specimens that were received >7-days after collection.

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

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.