NEW YORK, Sept. 17 Xenomics, Inc. (Pink Sheets:XNOM; FWB: XE7), a developer of next-generation medical DNA diagnostictechnologies, announced today that it has signed a licensing agreement withIpsogen SAS, a leading molecular diagnostics company based in France andConnecticut for the co-exclusive rights to develop, manufacture and marketresearch and diagnostic products for the stratification and monitoring ofpatients with Acute Myeloid Leukemia (AML).
AML is a clinically and molecularly heterogeneous disease with about13,500 new cases per year in the US and a similar number in Europe. Thedisease subgrouping by cytogenetic karyotyping indicates patient prognosis.However, in almost half of AML cases the karyotype appears normal. A recentdiscovery by Drs. Falini and Mecucci at the Institute of Hematology at theUniversity of Perugia in Italy showed that about 60% of adult AML with normalkaryotype have a mutation in the nucleophosmin (NPM1) gene.
Xenomics has obtained an exclusive license for the discovery and developeda test that detects all known 45 mutations of NPM1 in one reaction. Thisdiagnostic assay has been implemented in the US at CLIA-approved BRTLaboratories Inc. in Baltimore, Maryland, and is available for hematologistsand clinicians. In addition, Xenomics scientists have developed a sensitiveNPM1 monitoring test that can detect the presence of residual diseasefollowing chemotherapy. The combination of NPM1 diagnostic and monitoringassays can provide effective means of assessing and stratifying patientsduring ongoing clinical trials. The NIH currently lists 358 clinical trialsfor AML approved by human subject review boards.
"Xenomics is committed to expanding patient access to the NPM1 markerworldwide," said Dr. Samuil Umansky, Chief Scientific Officer of Xenomics,Inc. "With this acute disease, physicians need a rapid assessment of patientprognosis for effective use of chemotherapy. NPM1 provides an excellent testfor monitoring the minimal residual disease and patient response to anti-tumortherapy."
"This agreement with Xenomics, a leading company developing innovativeDNA-based tests, enables Ipsogen to further expand its unique range ofdiagnostic products dedicated to the disease management of blood cancers" saidVincent Fert, president and CEO of Ipsogen. "The NPM1 products will integrateIpsogen quantitative and standardized technology (FusionQuant(R) andProfileQuant(R)) to warrant the highest level of precision and quality forclinical laboratories and patients. The NPM1 test results have the potentialto help physicians with prognosis of the disease and with the monitoring ofthe patient response to therapy".
About Xenomics, Inc.
Xenomics is a molecular diagnostics company that focuses on thedevelopment of DNA-based tests using Transrenal DNA (Tr-DNA). Xenomics'patented technology uses safe and simple urine collection and can be appliedto a broad range of applications, including prenatal testing, tumor detectionand monitoring, tissue transplantation, infectious disease detection, genetictesting for forensic identity determination, drug development, and research tocounter bioterrorism. Scientists from Xenomics were the first to report thatfragments of DNA from normal cell death cross the kidney barrier and can bedetected in urine. The Company believes that its technology will opensignificant new markets in the molecular diagnostics field. Xenomics has threeissued U.S. patents covering different applications of the technology formolecular diagnostics and genetic testing and a European patent for theCompany's prenatal testing applications, and numerous pending patentapplications. For more investor-specific information, including daily andhistorical Company stock quote data, recent news releases and an Investor FactSheet, please visit http://www.xenomics.com. Xenomics is also listed on theFrankfurt Stock Ex