Adeza's Fetal Fibronectin Immunoassay to receive expedited FDA review.SUNNYVALE, Calif.--(HealthWire)--Jan. 16, 1995--Adeza Biomedical Corp. (Adeza) has received notification from the Food and Drug Administration (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. ) that its premarket approval application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) for a Fetal Fibronectin Immunoassay is "suitable for filing." The FDA also granted Adeza's PMA submission "expedited review status" based on the fact that "the Fetal Fibronectin Enzyme Immunoassay represents a clinically meaningful advantage over conventional diagnostic methods used to identify symptomatic women at risk for preterm delivery." Preterm delivery is the leading cause of infant morbidity and mortality Morbidity and Mortality can refer to:
pertaining to diagnosis by immune reactions. test developed to identify women at risk for prematurity. The economic impact of preterm delivery is estimated at $5 billion in the United States each year. Dan Wilds, Adeza's president states that "Once Adeza's test is approved, more objective diagnosis of preterm delivery should help physicians manage patients more successfully." Wilds indicated that the ability to better identify patients early is an important step in reducing the complications and major social and economic costs associated with preterm birth. This event also marks a milestone for Tokos Medical Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :TKOS TKOS The King of Spades (online multiplayer game) TKOS Turn Key Optimized Solutions (French company) ), Adeza's marketing partner in the United States. Dale Tyerman, Tokos vice president, said, "Tokos is pleased by the FDA's favorable response to Adeza's submission and we are excited about Fetal Fibronectin's potential for improving clinical management and for reducing the costs associated with prematurity." Adeza and Tokos are both companies pioneering significant advances in women's health care. Tokos Medical Corp. is a leader in maternal-newborn managed care services and the pioneer of obstetrical home healthcare including telemedical preterm labor management services. Tokos is headquartered in Santa Ana. Adeza Biomedical specializes in developing new diagnostic and therapeutic products for the women's health care market. Adeza is also developing diagnostic tests for ruptured amniotic membranes, preeclampsia preeclampsia /pre·eclamp·sia/ (pre?e-klamp´se-ah) a toxemia of late pregnancy, characterized by hypertension, proteinuria, and edema. pre·e·clamp·si·a n. and endometriosis. CONTACT: Adeza Biomedical Michele Baltay, 408/745-0975 Tokos Medical Corp. Nicholas A. Mione, 714/474-1616 |
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