Healthcare Industry News: Cytogen
News Release - September 17, 2007
Xenomics Announces Agreement with Ipsogen for Diagnostic Assays of LeukemiaNEW YORK, Sept. 17 (HSMN NewsFeed) -- Xenomics, Inc. (Pink Sheets: XNOM; FWB: XE7), a developer of next-generation medical DNA diagnostic technologies, announced today that it has signed a licensing agreement with Ipsogen SAS, a leading molecular diagnostics company based in France and Connecticut 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.
"Xenomics is committed to expanding patient access to the NPM1 marker worldwide," said Dr. Samuil Umansky, Chief Scientific Officer of Xenomics, Inc. "With this acute disease, physicians need a rapid assessment of patient prognosis for effective use of chemotherapy. NPM1 provides an excellent test for monitoring the minimal residual disease and patient response to anti-tumor therapy."
"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".
About Xenomics, Inc.
Xenomics is a molecular diagnostics company that focuses on the development of DNA-based tests using Transrenal DNA (Tr-DNA). Xenomics' patented technology uses safe and simple urine collection and can be applied to a broad range of applications, including prenatal testing, tumor detection and monitoring, tissue transplantation, infectious disease detection, genetic testing for forensic identity determination, drug development, and research to counter bioterrorism. Scientists from Xenomics were the first to report that fragments of DNA from normal cell death cross the kidney barrier and can be detected in urine. The Company believes that its technology will open significant new markets in the molecular diagnostics field. Xenomics has three issued U.S. patents covering different applications of the technology for molecular diagnostics and genetic testing and a European patent for the Company's prenatal testing applications, and numerous pending patent applications. For more investor-specific information, including daily and historical Company stock quote data, recent news releases and an Investor Fact Sheet, please visit http://www.xenomics.com. Xenomics is also listed on the Frankfurt Stock Exchange under the symbol XE7.
About Ipsogen SAS
Ipsogen is a molecular diagnostic company focused on the development and commercialization of innovative diagnostic products to guide and personalize treatment options in cancers. Ipsogen has built a comprehensive portfolio of unique products in blood cancers available in over 50 countries all over the world to leading institutions involved in cancer care. Ipsogen products are registered as IVD in Europe. Ipsogen recently established commercial and service agreements with major testing laboratories in the United States, Canada and Europe - Laboratory Corporation of America ® holding (LabCorp®), Warnex Inc. and DNA Vision. Ipsogen is headquartered in Marseille, France and has its U.S. offices in New Haven, Connecticut. For more information, please visit http://www.ipsogen.com.
Certain statements made in this press release are forward looking. Such statements are indicated by words such as "expect," "might," "should," "anticipate" and similar words indicating uncertainty in facts and figures. Although Xenomics believes that the expectations reflected in such forward- looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to be correct. As discussed in Xenomics' Form 10-KSB as filed with the Securities and Exchange Commission on May 16, 2006 and its other periodic reports, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: uncertainties associated with product development, the risk that Xenomics will not obtain approval to market its products, the risk that Xenomics' technology will not gain market acceptance, the risks associated with dependence upon key personnel, and the need for additional financing.
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