US-based molecular diagnostics company Cepheid has secured the CE mark for its molecular in vitro diagnostic test, Xpert NPM1 Mutation.

The test is intended to quantify mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from acute myeloid leukaemia (AML) patients.

Using automated real-time reverse transcription polymerase chain reaction, the test offers the per cent ratio of mutant NPM1 to ABL1 endogenous control mRNA transcripts.

Cepheid oncology medical and scientific affairs vice-president Dr Michael Bates said: “NPM1 mutations are found in approximately one-third of acute myeloid leukaemia cases and can be used to monitor response to therapy as well as to predict relapse.

“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.”

As part of minimal residual disease monitoring for AML patients with NPM1 mutations, the European LeukemiaNet advises the utilisation of quantitative molecular assessment of NPM1 through qPCR.

The new diagnostic test is said to complement the company’s haematology-oncology portfolio, which comprises Xpert BCR-ABL Ultra p190 and Xpert BCR-ABL Ultra.

In February this year, Cepheid received emergency use authorisation (EUA) from the US Food and Drug Administration for its Xpert Mpox test.

As part of the EUA, Xpert Mpox is now authorised for use in point-of-care settings on the GeneXpert Xpress systems.