Biex PMA Accepted for Filing by FDA; Application to Receive Expedited Review.

DUBLIN, Calif.--(BW HealthWire)--Aug. 28, 1997--Biex Inc. announced today that the Food and Drug Administration (FDA) has granted expedited review of the company's application for premarket approval (PMA) of its test for identifying women at risk for preterm labor and delivery.

The FDA's Center for Devices and Radiological Health accepted the PMA filing for the SalEst(TM) system, indicating that accelerated review is warranted because the test "provides for clinically important earlier diagnosis over existing alternatives for risk assessment of spontaneous preterm labor and preterm delivery."

The company noted that the application was accepted for filing only 29 days after it was submitted to the FDA.

The SalEst system was developed to help physicians determine which pregnant women require extra care aimed at reducing the consequences of preterm birth. The test identifies a surge in the hormone estriol, which research has shown is a signal that spontaneous preterm labor and delivery may occur within three weeks of testing.

Recently, a large-scale, multi-center research study found that women who have elevated levels of salivary estriol detected by the SalEst system are six times more likely to develop preterm labor and delivery compared to the traditional risk screening methods which only indicate a woman is twice as likely to deliver preterm.

The clinical trials also demonstrated that the SalEst system identifies 50 percent of the patients who delivered preterm but were overlooked by the traditional methods. The traditional methods screen pregnant women for risk by assessing obstetrical conditions, family medical histories and various behavioral, lifestyle and socioeconomic factors associated with preterm delivery.

Unfortunately, this traditional approach inaccurately classifies many women as high-risk candidates who are then given unnecessary, costly high-risk care. The traditional approach also misses many women who deliver preterm, low-birthweight babies.

Biex President and Chief Executive Officer James Edlund said, "The FDA will now begin an in-depth evaluation of the research findings. We are gratified that the agency responded so quickly to our submission and agrees that the potential benefits of the product justifies an expedited review. We will continue to direct our efforts toward meeting the FDA's data requests and preparing for the eventual introduction of the SalEst system."

Babies born preterm represent the foremost problem in obstetrical-neonatal medicine. Preterm birth is the leading cause of infant mortality and morbidity in the United States and worldwide. More than 400,000 babies are born preterm in the United States each year, representing 11 percent of all births. The preterm birth rate has increased in recent years in spite of significant advances in prenatal care.

Approximately $10 billion is spent annually on neonatal intensive care and other treatments resulting from prematurity and low birth weight. While various treatment strategies can be highly effective in improving birth outcomes for high-risk women, successful treatment is dependent upon early and accurate identification of risk.

Biex Inc., located in Dublin, is an emerging women's healthcare company focused on advancements in maternity management. -0-

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties, including, without limitation, risks of product nonapproval or delays or post-approval reviews by the FDA or foreign regulatory authorities, product development and market acceptance risks, product manufacturing risks, the results of financing efforts, and developments regarding intellectual property rights.

CONTACT: Biex Inc.

Edgar A. Luce, 510/556-0300