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Category Article Author Date
The Pitch
Xenomics, Inc. Craig A. Kasper, Au.D. 11/11/2004








Text Box:  Text Box: THE
Pitch
Corporate Office: Xenomics, Inc.

420 Lexington Ave., Suite 1701

New York, NY 10170 Phone: (212) 297-0808

Laboratory:

1 Deer Park Dr., Suite F Monmouth Junction, NJ 08852 Phone: (732) 438-8290

Founders:

Samuil Umansky, M.D., Ph.D., Dr. Sci., Hovsep Melkonyan, Ph.D.,

L. David Tomei, Ph.D.

Web site: www.xenomics. com

Background:

Xenomics Inc. is a molecular diagnos

tics company focused on providing newnon-invasive “molecular” solutions for existing problems. The Company is based on trans-Renal DNA (Tr-DNA) technology and holds the earliest  patents for use of Tr-DNA for diagnostic purposes.Tr-DNA is cell free circulating plasma DNA that crosses the renal barrier and ends up in the urine. Using a simple and safe urine specimen, this technology creates new molecular markets for a broad range of tests current­ly performed by older non-molecular methods.

Xenomics has already completed basic R&D, establishedproof-of-principle, secured issuance of broad US and International Patent protection, and has a peer-reviewedclinical database on more than 300 patients. The principalsof Xenomics believe that no other company can offer a comparable opportunity for truly non-invasive genetictesting, nor can other technologies perform such a broadrange of genetic testing on a single proven technology platform.

Currently the market for DNA testing is over $1.5 billionand it is growing at a rate of 30 % per annum. Xenomicscreates new molecular markets that may double the size ofthe existing market. The ease of collection, non-invasivenature, and low cost of Tr-DNA analysis suggests that thetechnology may ultimately become the method of choice for many genetic tests.

The Technology:

Xenomics’ proprietary Tr-DNA technology is based on a discovery made by Company scientists (Drs. Samuil Umansky and Hovsep Melkonyan) that DNA from the turnover of cells throughout the body is excreted from thebloodstream into the urine and can be used for moleculardiagnostic purposes. In comparison with conventional testsavailable today, the Tr-DNA technology offers significant advantages with respect to patient compliance, ease of testing, speed and cost. Tr-DNA tests from small urine specimens can be performed for prenatal diagnosis,tumor detection and monitoring, infectious disease detection and characterization, organ transplantation monitoring, drug development and outcomes monitoring, forensic identification and bioterrorism. Most importantly,




conventional methods and tech­niques, and the most advancedemerging technologies of DNAanalysis can be easily adapted to use Tr-DNA.

On April 11, 2004, Xenomics executed an agreement with the internationally renowned National Institute for InfectiousDiseases located in Rome, Italy. The joint-venture is called SpaXen Italia, SRL. Spaxen islocated inside the new, advancedlaboratory and hospital facilities of the National Institute in Rome. The laboratory’s missionis to develop new, highly sensi­tive and accurate diagnostic tests for a variety of infectiousagents. Initial focus is on detec­tion of HIV in urine, as well as

detection of tuberculosis and other infectious agents. BecauseTr-DNA provides a highly sen­sitive diagnostic platform usingsmall urine specimens, there are obvious and valuable appli­cations in the biodefense field.

Looking Forward:

Xenomics is currently under-taking a $6 million financing thatitexpectstocloseduring Q4, 2004.Proceedswill be used to finance activities as the Company transitionsfrom research and developmentinto product development. TheCompany’s initial target market is prenatal testing for Down syndrome. The ability to harvestand test fetal DNA in maternalurine as early as seven weeks of

pregnancy versus 14-15 weeksrequired for amniocentesis has already been demonstrated.Amniocentesis is a highly riskyprocedure that requires insertionof a needle into the amniotic sac and withdrawal of amniotic fluid for testing. In about 1% ofthese cases, the trauma resultsin spontaneous abortion of the fetus. Xenomics believes that application of its technology will revolutionize prenatal test­ing by substituting the high-riskamniocentesis procedure with a simple, safe and non-invasive urinesample. The plan for Xenomics is to bring its first product to market in about 24 to 30 months.


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