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NEW YORK -- Xenomics, Inc. (OTCBB:XNOM), a developer of next-generation medical DNA technologies, has announced the release of its Strategic Initiatives for 2005 and beyond. The report recaps major recent milestones in the Company's development of a proprietary Transrenal-DNA (Tr-DNA) platform to create a growing suite of advanced, non-invasive and highly accurate medical tests for a broad range of diseases and genetic conditions. It also outlines strategic goals for the coming year as the Company aggressively pursues its course of continued biomedical research and business initiatives.

"It is hard to describe the excitement that we are all experiencing at Xenomics as a result of a recent series of breakthroughs in our work, technologically, financially, and clinically," said Dr. Randy White, CEO of Xenomics. "Transrenal-DNA, which serves as the whole basis and focus of our commercial product development, may well become the platform of choice for molecular medicine and improve the medical community's ability to detect Down syndrome, HIV, TB and countless other diseases and conditions. Our mission is clear and simple - to become the leading provider of diagnostic tests in our chosen markets using our proprietary Tr-DNA technology. We believe we are on our way to achieving great success in diagnostics, and we have implemented a consistent, realistic strategy to get there. We are pleased with our early landmark accomplishments to develop our technology and lay a strong foundation for enhancing shareholder value."

Xenomics' team of scientists, headed by Dr. Samuil Umansky, was the first to discover the existence of Tr-DNA - genetic material that has passed through the kidneys and is excreted in the patient's urine. The Company is using this pioneering science to design a technology platform that serves as a gateway to the creation of a new generation of powerful, non-invasive genetic tests for a range of critical health care applications. The tests can be conducted on easily obtained urine samples, potentially ushering in a new generation of highly accurate, yet safe and non-invasive molecular diagnostic tests.

Xenomics milestones achievements for the past year include the following.

--Continued successful growth and strengthening of the Company's intellectual property portfolio, including the filing of four provisional patents

--Significant progress in the development of technologies that may lead to new prenatal tests for Down syndrome and other fetal genetic abnormalities.

--Filing of a provisional patent connected to its discovery of two Tr-DNA genetic markers that are unique to people with Down syndrome. The Xenomics Tr-DNA technology presents a number of potential advantages over existing methodologies used in prenatal genetic testing, including increased accuracy and broadened diagnostic information. Other potential advantages include the ability to be conducted at much earlier stages of pregnancy than existing DNA analysis methods, such as the invasive amniocentesis test, which carries greater risks and costs. Xenomics' Tr-DNA tests can likely be performed as early as 8 weeks into pregnancy, compared with amniocentesis or the triple screen, typically performed 16-22 weeks into pregnancy.

--Establishment of a new Department of Licensing and Intellectual Property to manage growth of its intellectual property portfolio. The Company hired veteran Patent Agent David Ladner to head the Department.

--Execution of a contract with North Shore-Long Island Jewish Health System, one of the nation's largest healthcare institutions, to commence human clinical studies to test the Company's proprietary technology for the creation of unique non-invasive prenatal tests to detect Down syndrome. Human clinical studies are critical steps in Xenomics path toward commercialization of its technologies.

--Execution of a research contract with Eastern Virginia Medical School (EVMS) of Norfolk, Va., to conduct human clinical studies of the Company's proprietary technology to detect several fetal genetic abnormalities, including Down syndrome.

--The closing of a private placement financing resulting in gross proceeds of approximately $6 million. Proceeds from the financing will help Xenomics as it continues to develop its TR-DNA technology in the coming year.

--Execution of a joint venture to conduct research on detection of HIV and other infectious diseases with the National Institute for Infectious Diseases (Instituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani") in Rome, in the form of a new R&D company called SpaXen Italia, S.R.L.

--Development of Tr-DNA technology to detect HIV through non-invasive urine samples. The Company believes that this application of its patented technology development platform may enable the creation of improved treatment for AIDS patients.

--Development of Tr-DNA technology to detect tuberculosis through non-invasive urine samples.

--Filing of an Italian national patent on technology to detect HIV and tuberculosis using Tr-DNA.

Xenomics also released its key Strategic Initiatives and direction for the coming year. "Our Tr-DNA technology has extremely broad market appeal in the medical diagnostics market, from our current focus fields to other, yet unexplored applications such as detecting cancer and even bioterrorism," said Dr. White. "But we feel that right now, Xenomics is best-served with highly targeted development efforts. That is the smartest direction for a company of our size, and which in our opinion will lead to the fastest growth in revenue and shareholder value."

The following are the key initiatives at Xenomics for the coming year:

--Strategic Initiative 1 - Expansion of Xenomics' intellectual property portfolio. This growth of patents, both pending and issued, substantiate the Company's competitive edge within the marketplace for improving diagnostic products for potentially millions of patients each year. It is Xenomics' intention to maintain the lead in developing Tr-DNA technology, by continuing to file proprietary protections of its innovative research and discoveries.

--Strategic Initiative 2 - Maintain Financial Strength and Solidify Funding. The Company plans to devote significant financial and human resources to further research and development in its effort to make commercially viable biomedical products that can help people worldwide. The Company's next product development phase will last through the 2006 fiscal year, and the Company believes its existing capital resources are sufficient to fund its operations through that date. However, to continue achieving progress beyond that date, the Company will need to raise additional capital in the coming year. It is the Company's intention to maintain consistent growth, and thereby assure manageable, long-term financial viability.

--Strategic Initiative 3 - Commence and Complete Clinical Testing of Prenatal Down Syndrome Screenings. Xenomics is excited about its new collaborations with the Eastern Virginia Medical School and North Shore-Long Island Jewish Health System. These collaborations are highly strategic alliances that provide Xenomics the crucial opportunity to commence human clinical trials of its potentially revolutionary yet simple urine test for prenatal detection of Down syndrome and other fetal genetic abnormalities. These research partnerships will be of instrumental importance to the Company's success in creating Tr-DNA tests that are superior to the current testing methods in every respect, including safety, diagnostic value, ease of use, efficiency, and cost.

--Strategic Initiative 4 - Continue Clinical Testing of Diagnostic Products to Detect HIV and TB. The Company intends to develop better screening methods for infectious diseases, particularly HIV and tuberculosis, through its new SpaXen joint venture in Rome. The National Institute for Infectious Diseases is a large AIDS treatment center that provides patient care to 4,000 infected patients each year. With that sort of size and capability, this alliance provides ideal access to human clinical trials and capability to further refine Xenomics HIV-related technologies and products. Once these solutions are fully developed, the Company's objective is to sell them to clinical laboratories and hospital laboratories that have been approved for performance of such high-complexity tests.



 
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