A new test developed by Adeza Biomedical Corp. appears topredict the likelihood of delivering a baby prematurely.

Bearing a baby too soon is the leading cause of newborncomplications, including death, in the United States, wheremore than 30,000 babies die each year from preterm birth.Moreover, the cost of saving babies who are born underweightand unable to breathe or feed properly is among the highest inthe country's health care system.

Adeza's monoclonal antibody detects a fetal form of theprotein fibronectin in vaginal or cervical secretions. In a studyreported today in the New England Journal of Medicine, the testfound high levels of fetal fibronectin in 93.8 percent of 65women whose uterine membranes broke before their babieswere due.

Patients with early contractions who had cervical or vaginalfetal fibronectin were far more likely to deliver before term -- 83 percent vs. 19 percent of 117 patients -- than those whotested negative.

Existing methods to predict early delivery rely ondemographics, previous problems or warning signs that areneither sensitive nor specific. Women often come into thehospital with labor too far along to stop, and doctors are oftenhard-pressed to distinguish between false labor andcontractions that will end in delivery.

Adeza's test is performed on vaginal or cervical secretionswabbed during a typical vaginal exam.

Presence of the protein in the vagina between 21 and 37 weeksgestation appears to correlate with risk of untimely labor anddelivery. The protein apparently functions in the region wherethe membranes of the placenta attach to the uterus. Early inpregnancy, attachment is not yet complete; later in pregnancy,the membranes may begin the normal process of detaching inpreparation for birth.

The presence of fetal fibronectin made it possible todistinguish between irrelevant uterine contractions and truerisk for preterm delivery, concluded the researchers, whoconducted the study at Mount Sinai School of Medicine in NewYork, St. Margaret's Hospital in Boston, and at the University ofCalifornia, Irvine.

"FDA trials are under way, and we are anticipating approvalsometime mid- to end of next year," Andrew Senyei, Adeza'schairman, told BioWorld. However, the company does not expectto use the study results in its application to the Food and DrugAdministration, he said.

Adeza, based in Sunnyvale, Calif., has been issued a patent onfetal fibronectin detection and has filed patents for use inperinatal diagnostics. "We were careful on the patents," Senyeisaid. "We were the first to discover this (marker protein), soour patent is clean."

-- Roberta Friedman, Ph.D. Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.