Hologic Inc. is touting a British study showing that testing pregnant women for a protein produced by the fetus can affect the way doctors treat their patients.
The study, by researchers at King’s College, London, was published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. It examined 97 tests for fetal fibronectin, a protein produced by fetal cells between the fetal sack and the uterine lining. Its presence in the vagina can be an indicator of possible pre-term delivery before 37 weeks’ gestation.
The study reviewed the results of the tests, of which 21 (or 22 percent) were positive. The researchers followed up on 91 of the tests, finding that the results of 28 percent of those caused the patients’ physicians to change their management of the cases.
And the doctors surveyed in the study said another 89 percent of the test results could have changed the way they handled their patients, regardless of the tests’ results.
“The results of fetal fibronectin testing directly influenced management in a significant number of patients. A large number of women were asymptomatic at testing. Fetal fibronectin testing could be offered more widely and has the potential to benefit patient management,” the researchers wrote.
Hologic said its FDA-approved non-invasive ffN test is designed for women between 22 and 35 weeks’ gestation. The company claims a negative result indicates a less than 1 percent chance of pre-term delivery within two weeks; a positive test, it says, “is a strong independent predictor of preterm birth before 32 weeks.”
