Cepheid receives CE mark for Xpert NPM1 Mutation 

June 2, 2023 – Cepheid announced that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia (AML). The test utilizes automated real-time reverse transcription polymerase chain reaction (RT-PCR) and reports the percent ratio of mutant NPM1 to ABL1 endogenous control mRNA transcripts. 

The European LeukemiaNet recommends quantitative molecular assessment of NPM1 by qPCR as part of minimal residual disease (MRD) monitoring of patients with NPM1-mutated AML. 

Acute myeloid leukemia (AML) is a cancer of the myeloid blood hematopoietic stem cells in the bone marrow and is known to have various Nucleophosmin (NPM1) exon 12 mutations. The mutations in the NPM1 gene lead to abnormal cytoplasmic localization of NPM1 and NPM1-interacting proteins, which means they’re unable to carry out their normal cellular functions. NPM1 is one of the most commonly mutated genes in AML. 

“NPM1 mutations are found in approximately one-third of Acute Myeloid Leukemia cases, and can be used to monitor response to therapy as well as to predict relapse,” said Michael Bates, MD, VP Medical and Scientific Affairs, Oncology. “The Xpert NPM1 Mutation test quantifies the mRNA transcripts of the A, B, and D mutations accounting for approximately 90% of NPM1 mutant cases, plus the ABL control gene, and provides an easy and convenient method of assessing response to therapy and improving the management of patients with AML.” 

Xpert NPM1 Mutation strengthens Cepheid’s hematology-oncology portfolio, which includes Xpert BCR-ABL Ultra and Xpert BCR-ABL Ultra p190, by offering an efficient workflow to measure NPM1 mRNA transcripts to improve care for oncology patients. 

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