Speed and sensitivity touted as proof of its utility as a prognostic tool.

Researchers at Asuragen and Johns Hopkins University School of Medicine report that an assay based on Asuragen’s NPM1 research-use only reagents was a versatile and specific tool for the screening of NPM1 mutations in patients with acute myeloid leukemia (AML). The high preliminary analytical sensitivity further suggests potential utility for the monitoring of residual disease in AML with a normal karyotype, according to the partners.

Determination of NPM1 mutation status has become essential for the molecular classification and prognosis of AML, according to the firms. The nucleophosmin gene is thought to be the most frequently mutated gene in de novo acute myeloid leukemias, particularly those with normal karyotype. Patients with NPM1 mutations typically do not carry cytogenetic abnormalities and generally respond better to induction chemotherapy than those without mutations.

Results of the Asuragen-Johns Hopkins study were published in the September issue of the Journal of Molecular Diagnostics. It details the evaluation of a laboratory-developed test based on Asuragen’s Signature® NPM1 Mutations Research Use Only reagents for the rapid detection of common NPM1 mutations using total RNA purified from cultured cells, bone marrow, or peripheral blood.

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 as well as 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.

Asuragen’s diagnostic product portfolio consists of a miRNA diagnostic assay for pancreatic cancer, quantitative assays for monitoring leukemia fusion transcript expression, genetic testing solutions for the fragile X mental retardation gene, and the Signature Oncology products for the qualitative detection of gene translocations and mutations in hematological and solid tumors. Asuragen has CLIA and GLP testing services as well as a cGMP manufacturing facility.

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