Ipsogen has announced the CE marking of its Profilequant WT1 kit.
The WT1 (for Wilms' tumour gene) biomarker is used in the prognosis and follow-up of normal karyotype AML patients, who account for nearly half of AML adult patients.
Quantification of WT1 expression level helps predict disease aggressiveness and determine patient response to treatment.
In a recent European study, WT1 proved to be a reliable indicator that can be used for minimal residual disease monitoring distinguishing patients at differing risk of relapse.
The WT1 assay has been developed in the context of a collaborative project coordinated by the ELN consortium, systematically evaluating nine different available assays to identify the best performing one.
'The WT1 gene has been reported to be switched on in the majority of cases of AML making it an attractive target for novel treatment approaches and monitoring response to therapy,' said David Grimwade, leader of the minimal residual disease working group of ELN.
'Therefore, there was a pressing need to develop a highly reproducible and reliable assay that quantifies WT1 transcript levels,' he added.
The CE marking obtained by Ipsogen for the Profilequant WT1 kit confirms the quality of its validation and manufacturing processes.
With this kit, Ipsogen continues to contribute to the standardisation efforts in place in Europe to reduce inter-laboratory variability and provide consistent results over time.
