TEST:

Xpert® NPM1 Mutation assay

Based on a Deming regression analysis, there was a high correlation (slope = 0.92; intercept = 0.12; Pearson's r = 0.982) between the quantitative results of the Xpert NPM1 mutation assay and the NPM1 mutA, mutB&D MutaQuant kit. The Xpert test quantitative results are thus highly correlated with the comparator method and the former has potential as a useful alternative for the monitoring of AML patients with a known NPM1 mutation.

An NPM1 mutation copy number estimator for Xpert® NPM1 mutation test was established, which will provide diagnostic and prognostic values for NPM1-mutated AML patients.

The synthetic NPM1 MutA Linearity Panel demonstrated high accuracy, precision, and linearity across the entire reportable range when utilized on Xpert NPM1 Mutation Assay. NPM1 External Control Panel, consisting of all three NPM1 mutation types, is vital for monitoring instrument and assay performance, and consistency in clinical labs worldwide. The controls are processed in the same manner as patient blood samples, providing operational familiarity for the end-user and monitors performance deviations of the assay.

"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."