Xenomics, Inc. has announced that it has signed a licensing agreement with Ipsogen for the co-exclusive rights to develop, manufacture and market research and diagnostic products for the stratification and monitoring of patients with Acute Myeloid Leukemia (AML).
AML is a clinically and molecularly heterogeneous disease with about 13,500 new cases per year in the US and a similar number in Europe. The disease subgrouping by cytogenetic karyotyping indicates patient prognosis. However, in almost half of AML cases the karyotype appears normal.
A recent discovery by Drs. Falini and Mecucci at the Institute of Hematology at the University of Perugia in Italy showed that about 60% of adult AML with normal karyotype have a mutation in the nucleophosmin (NPM1) gene.
Xenomics has obtained an exclusive license for the discovery and developed a test that detects all known 45 mutations of NPM1 in one reaction. This diagnostic assay has been implemented in the US at CLIA-approved BRT Laboratories Inc. in Baltimore, Maryland, and is available for hematologists and clinicians.
In addition, Xenomics scientists have developed a sensitive NPM1 monitoring test that can detect the presence of residual disease following chemotherapy. The combination of NPM1 diagnostic and monitoring assays can provide effective means of assessing and stratifying patients during ongoing clinical trials. The NIH currently lists 358 clinical trials for AML approved by human subject review boards.
"This agreement with Xenomics, a leading company developing innovative DNA-based tests, enables Ipsogen to further expand its unique range of diagnostic products dedicated to the disease management of blood cancers" said Vincent Fert, president and CEO of Ipsogen.
"The NPM1 products will integrate Ipsogen quantitative and standardized technology (FusionQuant® and ProfileQuant®) to warrant the highest level of precision and quality for clinical laboratories and patients. The NPM1 test results have the potential to help physicians with prognosis of the disease and with the monitoring of the patient response to therapy".