Cepheid Achieves CE Mark for Xpert® NPM1 Mutation Detection

Wednesday, May 31, 2023

Cepheid, a leading molecular diagnostics company, has recently received the CE mark for their Xpert® NPM1 Mutation test. This mark signifies that the test meets European regulatory standards and is deemed safe and reliable for diagnostic use in the European market. The Xpert® NPM1 Mutation test is specifically designed to rapidly detect and analyze mutations in the NPM1 gene, which are associated with certain types of cancer. This achievement underscores Cepheid's dedication to delivering advanced molecular diagnostic solutions to healthcare professionals and patients throughout Europe. For the most up-to-date and accurate information, I recommend visiting Cepheid's official website or contacting their customer support directly.

The European LeukemiaNet has recommended the quantitative molecular assessment of NPM1 mutations using qPCR for minimal residual disease (MRD) monitoring in patients with NPM1-mutated Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the myeloid blood cells in the bone marrow, and it is known to exhibit various mutations in the Nucleophosmin (NPM1) gene's exon 12. These mutations disrupt the normal cellular functions of NPM1 and its interacting proteins by causing abnormal cytoplasmic localization. NPM1 is one of the most
commonly mutated genes in AML.

Cepheid has developed the Xpert NPM1 Mutation test, which allows for the quantification of mRNA transcripts of the A, B, and D mutations, accounting for approximately 90% of NPM1 mutant cases. The test includes an ABL control gene for accurate measurement. This test provides a convenient and reliable method to assess therapy response and improve the management of AML patients.

Dr. Michael Bates, Vice President of Medical and Scientific Affairs in Oncology at Cepheid, emphasized the significance of NPM1 mutations in AML, stating that they are present in approximately one-third of AML cases. Monitoring these mutations can help evaluate treatment response and predict the likelihood of relapse. The Xpert NPM1 Mutation test expands Cepheid's portfolio in hematology-oncology, complementing other tests such as Xpert BCR-ABL Ultra and Xpert BCR-ABL Ultra p190. By offering an efficient workflow for measuring NPM1 mRNA transcripts, Cepheid aims to enhance the care provided to oncology patients.

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