Asuragen, Inc. Launches Signature® NPM1 Mutations (RUO): A Rapid Multiplex Assay For The Detection Of NPM1 Mutations

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Cancer / Oncology;  Medical Devices / Diagnostics
Article Date: 19 Aug 2008 - 2:00 PDT

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Asuragen, Inc. announced 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. According to Timothy Stenzel MD, PhD and Asuragen Chief Medical Officer, "This assay should prove highly useful to AML researchers wishing to investigate the potential clinical role for NPM1 mutation detection."

The streamlined multiplex workflow is compatible with other laboratory-developed assays using Signature® reagents. "This product adds another valuable addition to our Signature® product portfolio, including AML/ETO and INV 16 (A, D, & E) and represents the continuation of a series of product launches from our R&D pipeline, " said Dr. Matt Winkler, Chief Executive Officer and Chief Scientific Officer of Asuragen.

About Asuragen, Inc.

Asuragen is a fully integrated diagnostic company and molecular biology service provider, focused on molecular oncology and genetic diseases, with emphasis on microRNA (miRNA). Asuragen's current diagnostic product portfolio consists of Signature® Genetic Testing and Oncology Testing products as well as industry leading controls and standards engineered using its patented Armored RNA® technology. Asuragen is empowered with a high level of scientific expertise and assay development along with a well developed business infrastructure, GLP testing services and an established cGMP manufacturing facility that allows it to span the spectrum of discovery, testing, production and commercialization. Asuragen is dedicated to developing new technologies that will become cutting edge clinical products.

Asuragen, Inc.