Xenomics Signs Research Agreement with Eastern Virginia Medical School to Conduct Human Trials of Prenatal Tests for Genetic Abnormalities; Proprietary Transrenal-DNA Technology May Result in New Early-Pregnancy, Non-Invasive Prenatal Tests.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Xenomics, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :XNOM), a developer of next-generation medical DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. technologies, has executed a contract with Eastern Virginia Medical School Eastern Virginia Medical School, in Norfolk, Virginia is a public medical school. , a leading healthcare and educational institution, to begin human clinical trials of the Company's proprietary diagnostic DNA technology for the creation of completely safe and non-invasive prenatal tests for a range of genetic abnormalities, such as Down syndrome Down syndrome, congenital disorder characterized by mild to severe mental retardation, slow physical development, and characteristic physical features. Down syndrome affects about 1 in every 730 live births and occurs in all populations equally. . The research agreement between Xenomics and Eastern Virginia Medical School (EVMS EVMS Enterprise Volume Management System EVMS Eastern Virginia Medical School EVMS Earned Value Management System EVMS Earned Value Management Standard EVMS Embedded Voice Mail System EVMS Enterprise Vulnerability Management System ) of Norfolk, Va., for a collaborative clinical study that will investigate the ability of Xenomics' Transrenal-DNA (Tr-DNA) to detect a number of fetal genetic problems through analysis of urine samples of pregnant women. The clinical study is subject to review and approval by the institutional review board of EVMS. Xenomics also recently announced execution of a research agreement with North Shore-Long Island Jewish Health System, one of the nation's largest healthcare institutions, to conduct human clinical trials of its technique to detect Down syndrome in unborn children through analysis of maternal urine samples. "Starting these human trials is an important next step forward for Xenomics. It demonstrates our strong progress in continued execution of our business plan to develop products based on our Tr-DNA technology platform. These are required studies that we expect will lead to application to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for approval, and ultimately to deliver those products to the marketplace," said Dr. Randy White Randy White may refer to:
Transrenal-DNA is DNA that has passed through the kidneys and is eliminated in the urine. Xenomics scientists discovered that it is possible to detect genetic material of fetal origin that passes through the mother's kidneys into her urine. The Company is working to develop simple urine analysis tests based on its Tr-DNA technology to detect a range of prenatal genetic abnormalities, including Down syndrome, as well as other questions of genetic makeup. Additionally, Xenomics is developing tests for infectious diseases infectious diseases: see communicable diseases. such as AIDS and tuberculosis. Xenomics scientists believe the Company's 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 DNA analysis Any technique used to analyze genes and DNA. See Chromosome walking, DNA fingerprinting, Footprinting, In situ hybridization, Jeffries' probe, Jumping libraries, PCR, RFLP analysis, Southern blot hybridization. methods, such as amniocentesis amniocentesis (ăm'nēō'sĕntē`sĭs), diagnostic procedure in which a sample of the amniotic fluid surrounding a fetus is removed from the uterus by means of a fine needle inserted through the abdomen of the pregnant woman (see . In particular, urine analysis offers none of the risks, discomforts or costs associated with amniocentesis, in which amniotic fluid amniotic fluid n. The fluid within the amnion that surrounds the fetus and protects it from injury. Amniotic fluid The liquid that surrounds the baby within the amniotic sac. is extracted through a nine-inch needle inserted into the uterus, to obtain fetal DNA. Dr. Steven Warsof, Associate Professor and Director of Genetics and Prenatal Diagnosis Prenatal diagnosis The determination of whether a fetus possesses a disease or disorder while it is still in the womb. Mentioned in: Wiskott-Aldrich Syndrome prenatal diagnosis at the Center for Advanced Fetal Therapy at EVMS, who will serve as principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences on the trials, said the several-month-long study will examine the urine of pregnant women to detect the presence of four major chromosomal abnormalities, as well as gender information. "For a prenatal diagnostician the Xenomics technology is the holy grail of prenatal diagnostics," said Dr. Warsof. "If successful, it could revolutionize all of prenatal diagnostics. Currently, many patients are having invasive testing such as amniocentesis or chorionic villi sampling Chorionic villi sampling A procedure to remove a small tissue sample of the placenta, the sac that surrounds the developing fetus. This test can be performed as early as week 10 of the pregnancy. The tissue can be tested for genetic defects. , that puts their pregnancy at some risk, and that risk could be eliminated with this technology." Equally important, the Xenomics Tr-DNA tests might be able to be performed as early as only 8 weeks into pregnancy -- much earlier than is possible with amniocentesis, or other tests such as the triple screen which are typically performed 16-22 weeks into pregnancy. "To know the answers to these questions about the chromosomal health of the fetus would bring parents much more peace of mind and reduce their anxiety about the pregnancy," said Dr. Warsof. "Also, it could bring medicine's prenatal diagnosis powers within reach of virtually any women anywhere in the world, since it requires only the collection of a urine sample and delivery to a laboratory. In contrast, the amniocentesis procedure must be conducted in a medical facility. The first amniocentesis for prenatal diagnosis was conducted in 1972. "A simple urine test for prenatal genetic screening would be the culmination of 40 years of scientific inquiry," added Dr. Warsof. "It's what we have been striving for since prenatal diagnosis has been available." About Eastern Virginia Medical School Eastern Virginia Medical School serves the region of southeastern Virginia known as Hampton Roads Hampton Roads, roadstead, 4 mi (6.4 km) long and 40 ft (12.2 m) deep, SE Va., through which the waters of the James, Nansemond, and Elizabeth rivers pass into Chesapeake Bay. . One of the most populous regions of Virginia, Hampton Roads' largest cities include Chesapeake, Hampton, Newport News, Norfolk, Portsmouth, Suffolk and Virginia Beach. The main campus of EVMS is located in Norfolk, Virginia. EVMS works in partnership with hospitals, physicians, and clinics throughout the region, providing students and residents with a broad base of clinical experience. For the region as a whole, these educational partnerships spread the benefits of an academic medical center throughout the region, improving the quality of life and the quality of health care for the entire community. For more information, visit http://www.evms.edu. 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 Genetic Testing Definition A genetic test examines the genetic information contained inside a person's cells, called DNA, to determine if that person has or will develop a certain disease or could pass a disease to his or her offspring. , tumor detection and monitoring, tissue transplantation, infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. 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. |
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