Xenomics, Inc., a developer of next-generation medical DNA diagnostic technologies, announced today that its first diagnostic test developed for stratification of patients with Acute Myeloid Leukemia (AML) has been implemented at CLIA approved BRT Laboratories Inc. in Baltimore, Maryland, and is available for clinicians.
AML is the most common form of acute leukemia with about 13,400 new cases expected in 2007 in the USA and a similar number in Europe. Early detection of AML subtypes is important for development of a treatment strategy. The new test is based on a recent discovery of Drs. Falini and Mecucci at the Institute of Hematology at the University of Perugia in Italy that mutations in a nucleophosmin (NPM1) gene are characteristic of 30-40% of the cases of AML. NPM1 is a protein involved in regulation of ribosome biogenesis, cell division, cell death, and other important processes. Xenomics has obtained an exclusive license for the invention and developed a test that detects all 45 known mutations of NPM1 in a single reaction. The results will help physicians with prognosis, therapy, and monitoring of the disease.
Stratification of AML patients is also necessary for anti-AML drug clinical trials.