Study Links Fetal Fibronectin Testing With Changes In Management Decisions For Symptomatic And Asymptomatic Women At Risk For Preterm Birth

Main Category: Pregnancy / Obstetrics
Also Included In: Women's Health / Gynecology;  Fertility;  Biology / Biochemistry
Article Date: 20 Aug 2009 - 2:00 PDT

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Hologic, Inc. (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced the publication of the first of its kind study evaluating the impact of fetal fibronectin (fFN) testing among both symptomatic and asymptomatic pregnant women at risk for preterm birth. The study, "Does fetal fibronectin testing change patient management in women at risk of preterm labour?" by researchers at King's College, London, England appears in the on-line version of the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study conducted at the Maternal and Fetal Research Unit at St. Thomas' Hospital in London included nearly 100 clinically symptomatic and asymptomatic patients between 23 and 34 weeks gestation. After using the fFN test in both populations, clinicians were asked to determine if the results from the test changed the medical management of their patients. Clinician responses indicated that fFN testing had the potential to change management in nearly 90 percent of cases. The study concluded that fFN testing has the potential to improve risk assessment and impact treatment decisions including the administering of steroids, increased surveillance, or cerclage intervention in the asymptomatic high-risk population involved in the study.

"The results of our study clearly indicate that fFN testing 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," said Prof. Andrew Shennan, study co-author and Ob/Gyn at St Thomas' Hospital in London. "Another important benefit of fFN testing is the ability to avoid overtreatment of women with negative test results. In addition to providing assurance to women and their doctors that preterm birth is not imminent, fFN testing -- if more widely used in the asymptomatic population -- could also translate into significant cost savings to the health care system."

Hologic's fetal fibronectin test is an FDA-approved, non-invasive test that assesses the risk of preterm birth in women from 22 to 35 weeks gestation with known risk factors or with signs and symptoms of preterm labor. The fFN test measures the presence of fetal fibronectin, the glue-like substance that holds the baby in the womb. A negative result means fetal fibronectin is minimally present and there is a less than one percent chance of delivering in the next two weeks. A positive result is a strong independent predictor of preterm birth before 32 weeks.

Forward-Looking Statement Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the FullTerm(TM) fetal fibronectin test. There can be no assurance that the test will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the FullTerm fetal fibronectin test can only be determined on a case-by-case basis depending on the particular circumstances of the test and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect the Company's business and prospects are described in Hologic filings with the Securities and Exchange Commission.

Hologic and FullTerm are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Source: Hologic, Inc