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Sunday, 05/29/2005 1:17:22 AM

Sunday, May 29, 2005 1:17:22 AM

Post# of 82595
This company thinks getting their methods and genetic sample sites patented is very important.

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URL To Story: http://press.arrivenet.com/hea/article.php/645014.html

Xenomics Files Provisional U.S. Patent for Transrenal-DNA Detection of Down Syndrome for Prenatal Tests
Patent Filing comes as Company Launches Human Clinical Trials of Revolutionary Non-Invasive Prenatal Screening for Down Syndrome
Distribution Source : PRWeb

Date : Friday - May 27, 2005



New York, N.Y. (PRWEB) May 27, 2005 -- Xenomics, Inc. (OTCBB:XNOM), a developer of next-generation medical DNA technologies, has announced that it has filed a provisional patent connected to its discovery of methods to detect the genetic abnormality Down syndrome through the Company's proprietary Transrenal-DNA (Tr-DNA) detection technology.

"This is a major milestone accomplishment because it demonstrates the progress we are making in the development of noninvasive prenatal diagnostic tests for the public," said Xenomics' CEO Dr. Randy White. "The discovery of these markers by our scientific team and the filing of this patent also underscore the viability of our primary mission to create and market a simple urine test that effectively, easily and safely screens for Down syndrome in the fetus of pregnant mothers, based on our Tr-DNA technology platform."

The Xenomics provisional patent provides for methods that use a comparative analysis of carefully selected fragments of DNA contained in Chromosome 21, where the abnormality in Down syndrome patients occurs. Among certain of these fragments, called CpG islands, very specific markers referred to as methylation sites, have been found which are clearly distinct from normal chromosomal DNA. This invention is expected to be useful for diagnosing the presence or absence of Down syndrome using DNA samples taken from maternal bodily fluids, including urine, plasma, serum and amniotic fluid.

In the Xenomics study, two distinctive genetic markers were found in repeated studies of DNA obtained from nine volunteers who have Down syndrome. Those two markers were not present in samples collected from a control group of people who do not have Down syndrome.

The provisional patent filing with the U.S. Patent and Trademark Office validates Xenomics' continued progress in the development of its revolutionary Tr-DNA technology platform, which can detect DNA that traverses the kidneys and eventually are eliminated in the urine. The Company is using its unique technology platform to develop a range of tests for genetic abnormalities, HIV, TB and other diseases and conditions.

Xenomics recently announced execution of signed contracts to begin human clinical trials to test prenatal tests based on its proprietary Down syndrome detection technology. The clinical trials will be conducted in collaboration with two prominent healthcare centers, North Shore-Long Island Jewish Health System, one of the nation's largest healthcare institutions, and Eastern Virginia Medical School, a leading research and healthcare institution.

"We are anxious to begin further validation of these important markers on clinical samples," said Dr. Samuil Umansky, Xenomics co-founder and President. "Even as we begin our clinical studies we will continue our efforts to look for additional markers for Down syndrome and other life-threatening genetic problems like trisomy 13 and 18."

Xenomics is dedicated to creating and eventually marketing noninvasive, prenatal tests for a wide range of diseases and health conditions. Its first initiatives focus on the development of safe, non-invasive and highly accurate urine tests to screen for Down syndrome, TB, and HIV. The Company believes its proprietary Tr-DNA technology can enable the creation of prenatal tests that are more accurate, more informative and can be conducted much earlier in pregnancy than existing DNA analysis methods, such as amniocentesis. In particular, urine analysis offers none of the risks, discomforts or costs associated with amniocentesis, in which amniotic fluid is extracted through a nine-inch needle inserted into the uterus, to obtain fetal DNA.

About Xenomics, Inc.
Xenomics is a molecular diagnostic 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 genetic 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 pending European patent for the same applications. The Company has organized a joint venture to conduct research on infectious disease detection with the National Institute for Infectious Diseases (Instituto Nazionale per le Malattie Infettive "Lazarus Spallanzani") in Rome, in the form of a new R&D company called SpaXen Italia, S.R.L. For more information, please visit http://www.trilogy-capital.com/tcp/xenomics/website.html. For more investor-specific information, including daily and historical Company stock quote data and recent news releases, please visit http://www.trilogy-capital.com/tcp/xenomics. To read or download the Company's Investor Fact Sheet, visit http://www.trilogy-capital.com/tcp/xenomics/factsheet.html. To view an online video about Xenomics technology and products, visit http://www.trilogy-capital.com/tcp/xenomics/video.html. A TV news report about the Company's next-generation prenatal tests can be viewed at http://www.trilogy-capital.com/tcp/xenomics/ny1_video.html.

Forward-Looking Statements
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 the periodic reports of Xenomics, as filed with the Securities and Exchange Commission, 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.

(For additional information, please contact Randy White, Xenomics CEO, at 212-297-0808).

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ALEX MICHELINI PUBLIC RELATIONS
Alex Michelini
201 760-6383
E-mail Information
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I guess if you use a collection bottle instead of a cheek swab the process is more than different enough to patent without encroaching on the patents applied for by DNAP.

I imagine that the purpose of predetermining Down Syndrome is to allow early termination of pregnancy and then let the want to be parents try again.

Boy, we thought DNAP was going to have problems with people confusing geographical ancestry traits with racism! These guys are (if I understand the reason for the test) will be branded as promoting abortionists.

It would be great if a fertilized egg could have this determined before implantation, but in a strict theology, failing to implant a fertilized egg would be murder. As is of course the view of abortion held by some people. Doesn't matter when. Abortion is murder.

After all the reactions and activity about Terry Schiavo as a "right to life question" I think any pre-birth screening that might lead to "abortion" will recieve a very hot reception from many groups.

I feel great sympathy for the parents who are now given this option. It's not like they are saying "What! Blue Eyes! No Never!".

I hope I have not misconstrued the intent of such testing. I am unaware of any medical intervention that could reduce or prevent the appearance of Down Syndrome.

Stakddek