Cepheid Receives CE Mark for Xpert® NPM1 Mutation

Minimal Residual Disease Monitoring for Patients with NPM1-mutated Acute Myeloid Leukemia

SUNNYVALE, Calif., May 30, 2023 /PRNewswire/ -- Cepheid announced today 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 AML¹.

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.

CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.

1. Döhner H. et al, Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022 Sep 22;140(12):1345-1377

About Cepheid
Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company's solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com 

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