CytoCore Plans to Begin Trials on First-Ever Uterine Cancer Scan for Early Detection.Inexpensive Test Using the P2X7 Genetic Marker genetic marker n. A gene phenotypically associated with a particular, easily identified trait and used to identify an individual or cell carrying that gene. Anticipated Within Two Years CHICAGO -- CytoCore, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CYCR) today announced plans to begin trials for a quick, accurate, inexpensive screening test for endometrial endometrial /en·do·me·tri·al/ (en?do-me´tre-il) pertaining to the endometrium. endometrial, n relating to the end-ometrium or cavity of the uterus. and uterine cancers using a specialized computer-guided image recognition microscope system and the new P2X7 genetic marker to identify pre-cancerous cell changes. Much as the arrival of the Pap smear Pap smear or Papanicolaou smear Sample of cells from the vagina and cervix of the uterus for laboratory staining and examination to detect genital herpes and early-stage cancer, especially of the cervix. Developed by the Greek-born U.S. back in the 1960's launched routine screenings that have profoundly reduced the number of cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. deaths, CytoCore's new InPath System uterine uterine /uter·ine/ (u´ter-in) pertaining to the uterus. u·ter·ine adj. Of, relating to, or in the region of the uterus. and endometrial cancer Endometrial Cancer Definition Endometrial cancer develops when the cells that make up the inner lining of the uterus (the endometrium) become abnormal and grow uncontrollably. scan, with a wholesale price expected to be $100, will for the first time enable women at risk for uterine cancers and pre-cancers detected in their earliest stages. The fourth leading cancer among women, some 41,200 cases of uterine cancer will be reported in the United States this year, as compared with about 9,700 cases of cervical cancer, according to the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, . "Some 40 percent of American women between the ages of 35 and 70 exhibit risk factors for endometrial or uterine cancer such as obesity, hypertension, diabetes or family history," said Dr. Steven Waggoner, a nationally recognized gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. oncologist and member of CytoCore's medical advisory board. "CytoCore's new screening test has a potential target population of between 25 and 28 million women in the United States alone." Dr. George Gorodeski of University Hospital Case Medical Center in Cleveland (formerly University Hospitals of Cleveland University Hospitals is a major not-for-profit medical center in Cleveland, Ohio, United States. With 150 locations throughout northeast Ohio, it encompasses a network of hospitals, outpatient centers and primary care physicians. ), who is leading CytoCore's effort to bring the early detection test to fruition, sets forth the unusually high degree of accuracy associated with the P2X7 biomarker in an article appearing this month in the American Association for Cancer Research's journal "Cancer Epidemiology Biomarkers & Prevention." (The article may be viewed at: http://cebp.aacrjournals.org/cgi/content/abstract/15/10/1906) Dr. Gorodeski's study demonstrates that the P2X7 biomarker has a unusually high degree of accuracy for the detection of uterine epithelial cancers, both in terms of sensitivity (where it has scored between 92-100 percent) and specificity (90-100 percent). This combined accuracy is very high relative to the industry standard, which determines any biomarker's combined accuracy above 150 to be clinically useful. As with cervical cancer, a large number of endometrial and uterine cancers arise from a pre-malignant condition that responds best to early treatment. Currently, uterine cancer is most often diagnosed as a result of abnormal bleeding - which generally occurs after the opportunity for early identification has already been lost. CytoCore's new test, which Dr. Gorodeski said is about to begin clinical trials at UHCMC UHCMC University Hospitals Case Medical Center (Cleveland, OH) and other medical centers, is quick and minimally invasive. A newly designed "endometrial collector" gathers endometrial cells from the uterus with a flushing process that rinses and collects a saline solution saline solution n. A solution of any salt, usually an isotonic sodium chloride solution. Also called salt solution. Saline solution A solution of sterile water and salt used in a variety of medical procedures. through a thin catheter introduced into the uterus. The collected cells are then placed in a preservative preservative Any of numerous chemical additives used to prevent or slow food spoilage caused by chemical changes (e.g., oxidation, mold growth) and maintain a fresh appearance and consistency. Antimycotics (e.g. solution and sent to a lab, where they are tested for the expression of two markers, including the definitive P2X7 biomarker. CytoCore's AIPS AIPS Astronomical Image Processing System AIPS Astronomical Information Processing System AIPS Association Internationale de la Presse Sportive (French: International Sports Press Association) AIPS American Institute for Public Safety (Automated Image Proteomic System), a computer guided image recognition microscope system, uses fluorescence to tag and locate any positive cells out of the thousands screened in a typical lab sample. The company has applied for a patent request for its Endometrial Cancer Scan process, which includes the biomarker and the flushing method for cell collection. Currently some 50 million American women and 100 million women elsewhere around the world have Pap tests done each year at a cost that ranges from $70-$350 per test. CytoCore estimates that its Endometrial Cancer Scan, whose Phase I trial should be complete within the next six months, has a U.S. market potential in excess of $2 billion revenue annually. Completion of Phase II trials and 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. approval are expected within 24 months. "This is an exciting project with a strong scientific foundation and important clinical prospects for success," Dr. Gorodeski said. "The biomarker has been tested in a preliminary study of more than 100 patient samples and has consistently produced exciting results. This testing method, if successfully validated, could help care-givers reduce the prevalence of invasive uterine cancer and save the lives of many, many women." For further information, visit www.CytoCoreInc.com About CytoCore Inc. CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial, and other cancers. The InPath[TM] System is being developed to provide medical practitioners with highly accurate, low-cost, cervical and uterine cancer screening systems that can be seamlessly integrated into existing medical models. More information is available at: www.CytoCoreInc.com Dr. Gorodeski has a significant financial interest in this research consisting of equity and salary as consultant and Director of the Scientific Advisory Board of CytoCore. Dr. Gorodeski's invention licensed to CytoCore could generate royalty income for Dr. Gorodeski, for University Hospitals of Cleveland, and for CASE University. Certain statements in this release are forward-looking. These statements are based on CytoCore's current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore's expectations with respect to the InPath[TM] System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore's current expectation depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2005. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein. |
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