Adeza Biomedical's PMA Supplement to Expand the Use of its Preterm; Delivery Test Receives Expedited FDA Review.

SUNNYVALE, Calif.--(BUSINESS WIRE)--Aug. 12, 1996--Adeza Biomedical Corporation (Adeza) received notification from the Food and Drug Administration (FDA) that its Premarket Approval Application (PMA) supplement to expand the use of its Fetal Fibronectin Immunoassay to aid in detecting impending preterm delivery in women without symptoms of preterm labor has been granted expedited review status.

This is the second expedited FDA review granted for this assay. In late 1995, expedited review was also given to Adeza's original PMA submission which led to FDA approval of the Fetal Fibronectin Immunoassay as an aid in detecting impending delivery in women with symptoms of preterm labor.

Daniel O. Wilds, Adeza's President and Chief Executive Officer, commented that receipt of the second expedited review from the FDA marks the achievement of another important milestone in the commercialization of this breakthrough diagnostic test for preterm birth invented and patented by Adeza's Chairperson, Dr. Andrew E. Senyei, M.D.

Wilds stated, "FDA approval would extend the benefits of Adeza's Fetal Fibronectin Immunoassay to pregnant women who do not show symptoms of preterm delivery. Such asymptomatic pregnant women constitute approximately half of all preterm births each year in the U.S."

Wilds emphasized that early identification of patients is an important step in reducing the significant problems and costs associated with preterm birth.

Each year in the U.S., approximately 10% of all deliveries, more than 400,000, will be premature resulting in significant infant morbidity, over 30,000 infants deaths and an estimated $5 billion in added health care costs for procedures related to early delivery. Many infants who do survive suffer from long-term respiratory, cardiovascular and neurological disorders. Adeza's Fetal Fibronectin Immunoassay is the only immunodiagnostic test approved by the FDA to aid in detecting the risk of preterm delivery.

Adeza Biomedical is a pioneering biotechnology company that develops, manufactures and markets biomedical products and services specifically for women's pregnancy and reproductive health care problems including premature and late birth, preeclampsia, endometriosis and infertility. The company is headquartered in Sunnyvale, Calif.

CONTACT: Adeza Biomedical Corporation

Brian C. Unger, 408/745-0975