Asuragen announces results of study evaluating RNA-based assay for detection of common NPM1 mutations

Asuragen, Inc. announced today the results of a collaborative study with scientists at Johns Hopkins University School of Medicine evaluating a RNA-based assay for the rapid, sensitive and multiplex detection of common NPM1 mutations. The study results were published in the September issue of the Journal of Molecular Diagnostics.

“As a co-exclusive licensee of the Trovagene NPM1 technology, we are enabled to provide a commercial solution for NPM1 testing”

Determination of NPM1 mutation status has become essential for the molecular classification of acute myeloid leukemias (AML). The nucleophosmin gene (NPM1) is thought to be the most frequently mutated gene in de novo acute myeloid leukemias, particularly those with normal karyotype. The NPM1 mutation has important prognostic implications for patients with AML. Patients with NPM1 mutations typically do not carry cytogenetic abnormalities and generally respond better to induction chemotherapy than those without mutations. The published study reports the evaluation of the rapid detection of common NPM1 mutations using total RNA purified from cultured cells, bone marrow or peripheral blood using a laboratory-developed test based on Asuragen's Signature^® NPM1 Mutations Research Use Only reagents*. The assay uses multiplex RT-PCR in combination with fluorescent bead-based detection to simultaneously identify transcripts for NPM1 mutations A, B, D and J and wild-type targets.

Evaluation of 69 clinical specimens at initial diagnosis resulted in 100% agreement with reference methods. Of the AML patients with normal karyotype, 53% carried one of four different mutations detected by the assay. The results of this study demonstrate that the Asuragen NPM1 reagents are a versatile and specific tool for the screening of NPM1 mutations in patients with AML. The high preliminary analytical sensitivity further suggests potential utility for the monitoring of residual disease in AML with a normal karyotype.

"As a co-exclusive licensee of the Trovagene NPM1 technology, we are enabled to provide a commercial solution for NPM1 testing," said Rollie Carlson, President of Asuragen. "Our Signature^® NPM1 Mutations RUO kit complements our growing menu of cutting edge molecular diagnostic products for leukemia."