FDA approves diagnostic test as marker for preterm delivery.

SANTA ANA, Calif.--(BUSINESS WIRE)--Sept. 25, 1995--Tokos Medical Corp. (Delaware) (NASDAQ:TKOS) Monday announced that the Food and Drug Administration (FDA) has granted marketing approval for a diagnostic test to help physicians determine for symptomatic women if preterm delivery is imminent.

The test detects a protein, fetal fibronectin (fFN), a biochemical marker approved for predicting the risk for preterm delivery. When women develop preterm labor symptoms between the 24th and 34th week of pregnancy, physicians can use this test to help determine if delivery is imminent.

A positive result means special intervention may be needed. If the test is negative, the chances that delivery will occur within 7 to 14 days of testing are less than 1%.

Dr. Charles Lockwood, Chairman of Obstetrics and Gynecology at New York University Medical Center who led the initial fFN research, said, "This is an extremely important advance in our efforts to help determine when intervention is needed to reduce the consequences of preterm birth. These consequences are so severe and costly, most physicians believe it is better to treat a woman who ultimately may not need that treatment than risk the chance of an extremely low birthweight, preterm baby.

"The fFN test will help us better determine the acuity level of women with preterm labor symptoms. When the risk of preterm delivery is high, we can at least administer corticosteroids to accelerate fetal lung development, or ideally, provide treatment that allows the pregnancy to be prolonged. At the same time, we want to know when these costly interventions can be avoided or at least delayed. The fFN test will help us make that decision."

Preterm birth is the leading cause of infant mortality and morbidity and one of the most costly problems in healthcare. The Centers for Disease Control report that the preterm birth rate rose to 10.7% in 1992 up from 9.4% in 1981. Each year, it requires more than $5 billion just to provide the initial neonatal intensive care babies need to survive extreme low birthweight resulting from preterm birth.

Tokos Chief Executive Officer, Robert F. Byrnes, said the company was gratified by the FDA's commitment to give priority to their review of the fFN marketing application. "The fFN test is just one component of an overall comprehensive approach to reducing the incidence and consequences of preterm birth. It is, nonetheless, a very important component because it will help physicians justify the need for aggressive intervention or the need to take less intrusive, less costly measures," he said.

Byrnes said the company obtained exclusive U.S. and Canadian marketing rights to the product in 1991 from Adeza Biomedical Corporation, Sunnyvale, Calif. Byrnes added, "Helping physicians, payers and at-risk mothers address the problem of preterm birth has been our foremost goal. We pioneered services that help physicians detect and diagnose preterm labor more successfully, and now we can offer a reliable tool for determining which symptomatic women are truly threatened by preterm delivery."

Byrnes said the company expects to have the fFN test available by year end. Tokos is the leader in high risk obstetrical services which include preterm labor management, obstetrical home care and consultative obstetrical pharmacy services. The company also pioneered specialized managed care programs that include obstetrical risk screening, education, and maternal and newborn case management. The company's headquarters are located at 1821 East Dyer Rd. in Santa Ana.

CONTACT: Tokos Medical Corp., Santa Ana

Nicholas A. Mione, 714/474-1616

or

Adeza Biomedical

Daniel O. Wilds, 408/745-0975