Asuragen, Inc. has the launch of Signature® NPM1 Mutations (RUO), a multiplex reverse transcription PCR (RT-PCR) assay that enables the detection of NPM1 mutations. Asuragen’s Signature® NPM1 Mutations is a sensitive molecular assay for the combined detection of mutations A, B and D in exon 12 of the nucleophosmin (NPM1) gene. 

Asuragen is one of two exclusive licensees to NPM1. The assay is performed on the Luminex® 100™ IS or 200™ System using a liquid bead array method. The liquid bead array format provides comprehensive information in a single well, providing efficiency and cost benefits to the laboratory.

Signature® NPM1 Mutations can be used for the rapid detection and identification of mutations in NPM1. The assay is designed to detect NPM1 mutant transcripts in total RNA isolated from cell line, whole blood and bone marrow specimens. NPM1 has been reported to be one of the most commonly mutated genes in Acute Myeloid Leukemia (AML).

Nearly half of all AML patients present as normal karyotype (NK-AML), and half of these patients are NPM1 mutation positive. NPM1 mutations are thought to be an early event in the development of AML and once present, appear to remain stable. The discovery of the importance of the NPM1 gene also represents a rational approach for the development of molecularly targeted therapies making NPM1 mutation detection potentially useful in drug development research.