Published in FDA Law Weekly, May 26th, 2005
The test is U.S. Food & Drug Administration (FDA)-approved for the broad use of assessing the risk of preterm birth. It determines the presence of the fetal fibronectin protein in the birth canal. This adhesive protein works like a "glue," holding the maternal and fetal membranes together during pregnancy.
Fetal fibronectin is typically not present until the final 2 to 6 weeks of pregnancy. Women who are considered at high risk for preterm birth or who experience early signs and symptoms of labor - between 22 and 35...
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Source: FDA Law Weekly (2005-05-26)
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