FDA expedites approval for preterm delivery test.

SUNNYVALE, Calif.--(BUSINESS WIRE)--Sept. 26, 1995--Adeza Biomedical Corporation announced that the Food and Drug Administration (FDA) granted marketing approval for the first diagnostic test to aid in detecting impending preterm delivery in women with symptoms of preterm labor.

The test detects the presence of a protein, fetal fibronectin (fFN), which has been shown to be a biochemical marker predictive of imminent delivery when found in the vaginal secretions of women reporting symptoms of preterm labor between 24 and 34 completed weeks of pregnancy.

Each year in the U.S., approximately 10% of all pregnancies, more than 400,000, result in preterm delivery, which is the leading cause of infant mortality and morbidity. This major new aid in the diagnosis of preterm delivery is hoped 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 U.S. each year on procedures related to preterm delivery.

Adeza Biomedical submitted a pre-market application to the FDA in 1994 which was granted expedited review status based on the FDA's determination that the diagnostic test "represents a clinically meaningful advantage over conventional diagnostic methods used to identify symptomatic women at risk for preterm delivery."

On April 6, 1995, the FDA's Clinical Chemistry and Toxicology advisory panel unanimously recommended approval for the test.

Dr. Andrew E. Senyei, M.D., founder and chairperson of Adeza Biomedical, conceived and patented the simple diagnostic immunoassay. Senyei stated, "Fetal fibronectin sets a new standard in the management of prematurity and is the first step in the long road to eventual prevention of a major health problem. Being involved in its discovery and development has been highly gratifying because of the tremendous clinical value fetal fibronectin will bring to the management of prematurity."

Daniel O. Wilds, President and CEO of Adeza Biomedical stated, "This test is a significant step towards resolving a great challenge for physicians, which is the ability to know whether or not a patient with symptoms of preterm labor is actually going to deliver prematurely."

Dr. Charles Lockwood, M.D., chairperson of Obstetrics and Gynecology at New York University Medical Center, who led the initial fFN research effort and authored a lead article on fetal fibronectin in the September 5, 1991 issue of The New England Journal of Medicine said, "This assay represents a revolutionary advance in the physician's ability to diagnose preterm delivery."

Adeza Biomedical will market and sell the test in the U.S. through Tokos Medical Corporation, who will conduct a national launch before the end of the year.

Adeza Biomedical Corporation is a pioneering biotechnology company in the development, manufacture and marketing of biomedical products specifically for women's health care. The company is headquartered in Sunnyvale, Calif.

Tokos Medical Corporation, a leader in maternal-newborn managed care services, is headquartered in Santa Ana, Calif.

CONTACT: Adeza Biomedical Corporation

Daniel O. Wilds, 408/745-0975