NEW YORK – Danaher subsidiary Cepheid announced on Tuesday that it has received CE-IVD marking for its molecular Xpert NPM1 Mutation assay for patients with acute myeloid leukemia (AML).
The RT-PCR test quantifies mutant nucleophosmin (NPM1) mRNA transcripts — types A, B, and D in exon 12 — in peripheral blood specimens from patients with AML and reports the percent ratio of mutant NPM1 to ABL1 endogenous control mRNA transcripts, the company said in a statement.
Mutations in the NPM1 gene cause abnormal cytoplasmic localization of NPM1 and NPM1-interacting proteins, meaning they're unable to carry out normal cellular functions. NPM1 mutations are found in about one-third of AML cases and "can be used to monitor response to therapy as well as to predict relapse," Michael Bates, Cepheid's VP of medical and scientific affairs for oncology, said in a statement. The A, B, and D mutations account for approximately 90 percent of NPM1 mutant cases, he added.
The test "provides an easy and convenient method of assessing response to therapy and improving the management of patients with AML," he said.