Completion of PadKit Clinical Feasibility Study Announced by A-Fem Medical Corporation.PORTLAND, Ore.--(BUSINESS WIRE)--Aug. 24, 1998--A-Fem Medical Corporation (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) ), today announced that it has completed the initial clinical feasibility study for its proprietary PadKit(TM) collection device with very encouraging results which have led to the initiation of the next step for regulatory clearance. The PadKit is A-Fem's patented menstrual collection kit. This collection kit is targeted to be a clinical alternative to the cervical scrape, which is currently planned to be used for the Pap test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. procedure. The PadKit facilitates testing 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. with the self collected menses menses /men·ses/ (men´sez) the monthly flow of blood from the female genital tract. men·ses n. sample collected prior to a woman's normal annual exam, thus eliminating the need for a cervical scrape in the health care provider's office. The menses sample is collected with A-Fem's new feminine protection product, the miniform. The kit will then be sent to a qualified laboratory for analysis, and the result provided to the health care professional, prior to the scheduled appointment. "This signals the completion of the first phase of our work to validate this exciting technology. We will now embark upon further clinical studies looking toward regulatory clearance," said William H. Fleming, Vice Chairman of A-Fem Medical. "While advances have been made to improve the accuracy of 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. testing, we believe that the convenience, comfort and safety of our non-invasive PadKit has the potential to significantly improve annual testing compliance. This exciting advancement, which provides test results to the health care provider prior to an exam, has the potential to increase patient confidence, improve the quality of the office visit, and importantly -- advance 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. Independent market surveys indicate that the Pap test market is currently a $1 Billion market, encompassing over 30 million tests per year in the U.S. A-Fem Medical Corporation is a women's health care technologies company. The company has developed three proprietary technology platforms: the Miniform, RapidoSense(TM) and the PadKit(TM). A-Fem currently markets the inSync(R) miniform, an alternative to tampons, pads and liners for light flow protection. The company is developing point-of-care diagnostics providing quantification of results based on its proprietary RapidoSense(TM) technology. For more information visit our website at www.afem.com. 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 form 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 its clinical studies, manufacturing and distribution for the PadKit, or if developed may not be approved by 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. or be marketable and other risks detailed from time to time in the company's reports to the Security 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 Dec. 31, 1997.
CONTACT: A-Fem Medical Corporation
Hilary Reinmuth or Steven Frankel, 503/968-8800
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