A-Fem Medical Corp. Announces Major Developments for PadKit Technology; Patent Issuance and Phase I Clinical Studies For Diagnostic Application.PORTLAND, Ore.--(BW HealthWire)--Feb. 24, 1998--A-Fem Medical (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: AFEM AFEM Armed Forces Expeditionary Medal AFEM Air Force Emergency Management (US Air Force) ), announced today that the U.S. Patent and Trademark Office will issue a patent on March 10 (U.S. Patent No. 5,725,481) for the technology that is the basis for A-Fem's innovative new women's diagnostic product. The company also announced today that Phase I clinical studies for the PadKit(tm) will begin in early March. The PadKit is designed to provide an alternative to the cervical scrape for collecting samples for 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. screening and an alternative collection method to test for other cancers and diseases. The technology will be patented for the "Method and Apparatus for Collecting Vaginal Fluid and Exfoliated Vaginal Cells for Diagnostic Purposes." "Currently over 30 million Pap tests are performed annually to test for cervical cancer at a cost of more than $1 billion per year. Although significant improvements have been made in the area of Pap test sample reading and sample preparation, no consistent sample collection method has been developed," stated William Fleming William Fleming is the name of:
Phase I clinical studies are being conducted by Legacy Health Systems in Portland, Oregon. The clinical studies are the first step in determining whether a menstrual sample collected with the PadKit can be used in place of the conventional cervical scrape for a Pap test. If Phase I clinical studies are successful, the company plans to undertake a multi-center clinical study by early 1999, the results of which would be part of a submission 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. to obtain marketing approval for the PadKit for commercial distribution. The PadKit is the first planned diagnostic application of the company's miniform, which is currently being sold as a new form of feminine protection under the brand "inSync(TM)". The PadKit contains a miniform for use as a collection device to collect a sample during the normal menstrual cycle menstrual cycle n. The recurring cycle of physiological changes in the uterus, ovaries, and other sexual structures that occur from the beginning of one menstrual period through the beginning of the next. . The miniform collects blood along with numerous cells, vaginal mucous mucous /mu·cous/ (mu´kus) 1. pertaining to or resembling mucus. 2. covered with mucus. 3. secreting, producing, or containing mucus. mu·cous adj. 1. and discharge flushed out by the menstrual flow menstrual flow Menstrual discharge, period Gynecology The vaginal bleeding that occurs monthly from menarche to menopause, which lasts for 2–7 days of a discharge averaging 60–70 mL. See Menstruation. . This sample may provide an alternative to the cervical scrape for cervical cancer screening and/or provide a sample to test for other conditions, including 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. . Endometrial cancer kills as many women in the U.S. each year as cervical cancer. The endometrial cancer screening market is largely untapped because sample collection currently requires invasive procedures. The PadKit could be the first non-invasive, at-home collection device and could open up a new market for endometrial cancer screening. The PadKit will allow a woman to collect a sample in the privacy of her own home. A sample collected with the PadKit could be analyzed by a lab and the results provided to the physician prior to a patient's office visit. This would allow appropriate procedures, such as a confirming smear, coloscopy co·los·co·py n. See colonoscopy. coloscopy see colonoscopy. , biopsy or surgery, to be scheduled during the actual visit. Samples may also be used for repeated testing and/or additional testing, and may be stored for further testing at a later date. A-Fem Medical Corporation is a product development company dedicated to women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. care. A-Fem currently markets the inSync miniform, an alternative to tampons, pads and liners for light flow protection. In addition to the miniform and the PadKit, A-Fem is developing point-of-care diagnostics providing quantification of results based on its proprietary Rapid-Sense(TM) technology. For more information, visit the company's website at http://www.afem.com. -0- Note to Editors: The discussion in this press release regarding A-Fem Medical Corporation ("Company') contains forward looking statements (as defined in Section 27A of the Securities Act of 1933, as amended) that involve risks and uncertainties. Actual results could differ materially from those projected in the forward looking statements. Risks include, but are not limited to, the risks that the Company may not be able to attract the additional funding necessary to complete clinical studies, manufacturing and distribution of the PadKit, or if developed may not be approved by the FDA or marketable and other risks detailed from time to time in the Company's reports to the Securities and Exchange Commission, including the Company 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, 1996. CONTACT: Burson Marstellar Scott Marx, 415/764-1348 or A-Fem Medical Corp. Hilary Reinmuth, 503/968-8800 Ext. 17 |
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