Adeza Biomedical Receives FDA Approval for Preterm Delivery Test for Asymptomatic Women.

SUNNYVALE, Calif.--(BUSINESS WIRE)--Jan. 13, 1997--Adeza Biomedical Corp. (Adeza) announced that the Food and Drug Administration (FDA) approved Adeza's premarket approval (PMA) application supplement for expanding the intended use of Adeza's diagnostic test to detect the risk of preterm delivery to include women without symptoms of preterm labor.

The FDA granted Adeza expedited PMA approval for the use of this test in women with symptoms of preterm labor in September 1995. The test detects the presence of a protein, fetal fibronectin (fFN), which has been demonstrated to be a biochemical marker predictive of preterm delivery when found in the vaginal secretions of women between 24 and 34 completed weeks of pregnancy.

The approved Intended Use Statement states that the positive predictive value of the fFN Test for delivery in 34 weeks or less, 6 days represents an approximate 4- to 7-fold increase in risk over the reliability of predicting delivery given no test information. It further states that the negative predictive value of the fFN Test makes it highly likely that delivery will not occur in this time frame.

Andrew E. Senyei, M.D., founder and chairperson of Adeza Biomedical, conceived and patented the simple diagnostic immunoassay. Dr. Senyei stated: "The fFN Test is a revolutionary advance to assist physicians in diagnosing preterm delivery. This approval is another significant step toward improving the health care of women and infants and toward the eventual prevention of a major health problem."

Daniel O. Wilds, Adeza's president and chief executive officer, stated: "This approval is another important achievement towards fulfilling Adeza's mission to improve the health of women and babies as it addresses one of the most significant medical conditions affecting infant morbidity and mortality."

Each year in the United States, approximately 10% of all pregnancies, more than 400,000, result in preterm delivery, which is the leading cause of infant mortality and morbidity. The use of the fFN Test in diagnosing preterm delivery is expected to result in the saving of infant lives, reduce the emotional trauma for families of preterm infants, and reduce the more than $5 billion spent in the United States each year on procedures related to preterm delivery.

Adeza Biomedical Corp. is a Sunnyvale-based 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.

Adeza's Fetal Fibronectin Test is the only immunodiagnostic test approved by the FDA to aid in detecting the risk of preterm delivery. Adeza markets and sells the fFN Test in the United States through Matria Healthcare Inc., headquartered in Marietta, Georgia.

CONTACT: Adeza Biomedical Corp., Sunnyvale

Brian C. Unger, 408/745-0975