Xenomics, Inc. (XNOM.PK), a developer of transrenal molecular diagnostics, announced today that it has filed a patent application on novel technology for the detection of Human Papilloma Virus (HPV) DNA, based on Xenomics transrenal DNA technology. The technology would be applied to urine-based HPV screening.

“The HPV patent will be a valuable addition to Xenomics’s extensive transrenal DNA/RNA patent portfolio,” commented Bruce A. Huebner, CEO of Xenomics. “The HPV market offers our business a large market opportunity and is one of our leading product development priorities. Our plan is to develop a wide range of tests that utilize our patented urine-based transrenal DNA/RNA technology which include assays to detect mutations in solid tumor cancers and organisms that cause infectious diseases. We will pursue a combined collaboration and development strategy which includes identifying corporate partners in Japan and Europe, while Xenomics focuses on development of products for the North American market.”

At present, about 55 million Pap smears and 10 million HPV tests are performed annually in the US. The U.S. market for HPV tests, about $240 million in 2008, is growing at a rate of 20% to 40% annually. This market is currently dominated by Qiagen® (Nasdaq:QGEN), Hologics (Nasdaq: HOLX), Roche (RHO5:GR) with the expected entry of Gen-Probe® (Nasdaq: GPRO) in the near future. The market is projected to continue to experience rapid growth based upon more market awareness after the introduction of the HPV vaccine, Gardasil®, which was developed by Merck & Co. (NYSE: MRK).

The TrovaGene HPV DNA test involves isolation of DNA from urine and specific PCR amplification of the HPV E1 region to detect the presence of high-risk HPV types. In a recent study presented at the 2009 ASCO meeting, results were compared to the hc2 High-Risk HPV DNA Test® (QIAGEN®). Of 320 patients tested, 248 samples (77.5%) were concordant between the TrovaGene and hc2 assays. Using DNA sequencing as the gold standard, the TrovaGene test had a Sensitivity of 93.0% and a Specificity of 96.0%. In comparison, the hc2 assay has a reported Sensitivity of 93.0% and a Specificity of 61.1%. These initial data indicate superior performance for the TrovaGene assay to the current market leading assay.

The hc2 and other HPV tests that are currently available all rely on cervical scraping in female patients or swabbing of the penile urethra in males. The TrovaGene HPV DNA test needs only a urine sample and can be used to screen both males and females. Recent information suggests that testing males will help to better control the spread of this virus.

About Xenomics, Inc. and TrovaGene TM, Inc.

The company has focused on the development of DNA and RNA-based tests using Trans-renal DNA (Tr-DNA) or RNA (Tr-RNA). Its patented technology uses safe and simple urine collection and can be applied to a broad range of applications, including tumor detection and monitoring, infectious disease detection, prenatal testing, tissue transplantation, genetic testing for forensic identity determination, drug development, and research to counter bioterrorism. Its TrovaGene, Inc. subsidiary was formed principally to provide a mechanism to change the company’s corporate domicile from Florida to Delaware and the company’s corporate name by statutory merger. The company’s founding scientists 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. The company has been issued three 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, as well as numerous pending patent applications.

Statements about the company's expectations, applications of its technology, markets, and other statements that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management's current beliefs, assumptions, estimates and projections. Actual results may differ materially from those projected in the forward-looking statements for various reasons, including risks associated with product development, government regulation, market acceptance, dependence on key personnel, obtaining financing and other factors.