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Xenomics announces license with Asuragen for NPM1 leukemia diagnostics.

Xenomics, Inc. (New York, NY) has granted Asuragen, Inc. co-exclusive worldwide rights to incorporate NPM1 technology into Asuragen's molecular diagnostic products. Under the terms of this agreement, Asuragen will have the right to develop, manufacture and market products for the diagnosis, stratification and monitoring of patients with Acute Myeloid Leukemia (AML).

AML is a clinically heterogeneous disease with an estimated 13,500 new cases per year in the United States and 200,000 worldwide. The disease subgrouping by karyotypic abnormalities indicates patient prognosis. However, in almost half of AML cases the karyotype appears normal and provides no guide for the physician. A recent discovery by Drs. Falini and Mecucci at the University of Perugia showed that many AML patients have mutations in the nucleophosmin (NPM1) gene, a favorable marker for clinical outcome. Xenomics holds exclusive rights to the discovery and has co-exclusively sub-licensed mutations of the NPM1 gene to Asuragen, for diagnostic test development. The results of such a test will help physicians select patients with a good prognosis of benefiting from intensive chemotherapy, while sparing others with a low probability of benefit from the toxic treatment.

The NPM1 mutation may also be used to monitor AML patients for residual disease during chemotherapy. Monitoring is typically performed every three months per patient. Patient monitoring may be a key factor in over 400 ongoing clinical AML trials listed by the National Cancer Institute.

"Xenomics is committed to expanding patient access to the NPM1 marker worldwide," said Dr. Samuil Umansky, Chief Scientific Officer of Xenomics, Inc. "With this 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."

"Adding NPM1 mutation testing to the treating physician's testing arsenal will enable physicians and patients to make more informed choices in the treatment of AML," said Rollie Carlson, President of Asuragen. "NPM1 testing complements Asuragen's current leukemia products (Signature LTx RUO) and we continue in our dedication to bring leading edge leukemia diagnostic products such as NPM1 testing to the AML community."

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 United States 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.

Asuragen is a fully integrated diagnostics company focused on molecular oncology and early detection of cancer, with emphasis on microRNA. Asuragen's current diagnostic product portfolio consists of Signature Genetic Testing and Oncology Testing products, as well as industry leading controls and standards engineered using its patented Armored RNA technology. Asuragen is dedicated to developing new technologies that will become cutting edge clinical products. In addition to being empowered with high level scientific expertise, Asuragen has a strong business infrastructure, GLP testing services and an established cGMP manufacturing facility that allow it to span the spectrum of discovery, testing, production and commercialization.

Asuragen, Inc.


Xenomics, Inc.

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Publication:BIOTECH Patent News
Date:Sep 1, 2007
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