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 SAN DIEGO, Nov. 1 /PRNewswire/ -- QUIDEL Corp. (NASDAQ: QDEL), a leading developer and marketer of rapid diagnostic tests, today said it has filed a 510(k) pre-market notification for its SafePlan(TM) product with the United States Food and Drug Administration (FDA). This new diagnostic test is a novel, non-invasive product to be marketed to consumers, identifying the post-ovulatory infertile period that occurs each month in women's fertility cycles. SafePlan(TM) is intended to be the first of several unique new products designed to check the fertility status of women's monthly cycles.
 SafePlan(TM) is a simple and rapid (five-minute) urine test that measures the hormone metabolite pregnanediol glucuronide (PDG). PDG concentrations that reach and exceed a defined threshold level, correspond to the time when women are considered to be in the post- ovulatory nonfertile period, and thus are biologically unable to become pregnant. The company believes SafePlan(TM) could be an attractive alternative to many women who desire a non-invasive means of avoiding pregnancy without the undesirable features of other invasive and inconvenient methods, including the side effects associated with oral contraceptives, intrauterine devices, and spermicides. In addition, SafePlan(TM) allows sexual spontaneity not afforded by many other forms of birth control by identifying the 10-15 non-fertile days that occur each month following ovulation.
 In the United States alone, there are an estimated 39 million women who are at risk of unintended pregnancy. The primary market for SafePlan(TM) consists of married couples and women in monogamous relationships who are not using condoms for protection from sexually transmitted diseases. This group includes approximately 4 million women, motivated out of religious and personal reasons, who practice Natural Family Planing (NFP) and withdrawal, or who are presently not using any method of birth control. In addition, the company believes its market potentially includes 8 million women who use over-the-counter products such as condoms, sponges, diaphragms, and spermicides. Worldwide, these numbers are believed to be considerably larger for all segments.
 "The milestone filing represents the culmination of several years of development research and consumer clinical testing," said Scott L. Glenn, chairman and chief executive officer of QUIDEL. "The significance of this product extends beyond QUIDEL in that it represents a unique new option for women who want to choose a non-invasive method to determine when they will not become pregnant. Equally important, we were issued a patent last year for this method, giving us broad protection and extending our proprietary position in the rapid immunodiagnostic marketplace." Glenn went on to say, "We are presently in discussions with our partner, AKZO, who has worldwide marketing rights, regarding the marketing plans for SafePlan(TM), but as of yet, have not reached consensus or assurance on several issues. Recent discussions indicate our partner may elect not to actively participate in the product introduction, however, our successful launch and the extensive distribution network for our Conceive(TM) fertility products in the United States consumer market coupled with our two acquisitions and joint venture completed in Europe, have prompted our discussions to include the possible transfer of certain marketing rights to QUIDEL. We hope to finalize our discussion in the next few months."
 QUIDEL Corp. develops, manufactures and markets rapid immunodiagnostic products for family planning and family care. These products, which provide simple, accurate and cost-effective diagnoses in the areas of human fertility, infectious diseases, allergy, and autoimmune disorders, are designed for use in the physician's office, clinical laboratory and home testing markets.
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 /CONTACT: Scott L. Glenn, chairman and CEO, 619-552-7900, or Mark Francois, director, Investor Relations, 619-552-7931/

CO: QUIDEL Corp. ST: California IN: MTC SU: PDT

LS-MF -- SD001 -- 8950 11/01/93 08:05 EST
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Publication:PR Newswire
Date:Nov 1, 1993

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