First At-Home Screening Test For Amniotic Fluid Leakage During Pregnancy Now Available

Main Category: Pregnancy / Obstetrics
Also Included In: Medical Devices / Diagnostics
Article Date: 14 Aug 2008 - 0:00 PDT

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AmniScreen™ is the first and only FDA-approved at-home screening test for amniotic fluid leakage during pregnancy, a condition that may lead to serious complications such as infection and preterm labor. AmniScreen™ is now available by prescription only and can be purchased in retail pharmacies. AmniScreen™ is a panty liner test that offers the convenience of at-home screening for pregnant women who experience unexplained vaginal wetness. One AmniScreen™ test kit contains three panty liners and three drying trays, offering screening just about anytime, anywhere.

"AmniScreen™ may offer reassurance to women concerned about unexplained vaginal wetness during pregnancy," says Nancy Jasper, MD, Assistant Clinical Professor, Department of OB/GYN, Columbia University, College of Physicians and Surgeons. "It's important to know when wetness may be caused by amniotic fluid leakage. This new tool provides pregnant women with an effective way to identify unexplained wetness, with easy-to-read results that should be discussed with their healthcare provider. This important new test is an additional resource which may provide healthcare providers with information to help determine the necessity of a patient hospital or office visit."

How AmniScreen™ Works

AmniScreen™ works by detecting elevated pH levels, which may indicate amniotic fluid leakage. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care. The pivotal trial demonstrated that AmniScreen™ detected amniotic fluid leakage about 96% of the time. During the trial, patient-read results and clinician-read results matched more than 97% of the time.

Potential Candidates

Pregnant women who experience unexplained vaginal wetness are potential candidates for AmniScreen™. Additional candidates include high-risk pregnant women, women who have undergone amniocentesis, have experienced prior amniotic fluid leakage, and those who are concerned about unexplained wetness.

Safety Information

The AmniScreen™ Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. A pH level greater than or equal to 5.2 produces a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.

AmniScreen™ should not be used if less than 12 hours have passed since sexual intercourse or vaginal douching. AmniScreen™ should not be used if there is vaginal bleeding or spotting. A healthcare provider should be consulted if there is unexplained wetness, vaginal bleeding or spotting, or suspicion of vaginal infection.

Please see full Prescribing Information. For more information, please visit http://www.amniscreen.com

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 27 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S. For more information, visit http://www.barrlabs.com.

About Duramed Pharmaceuticals, Inc.

Duramed Pharmaceuticals, Inc., which develops and markets proprietary (branded) pharmaceutical products in North America, focuses primarily on products for women and emphasizes the development and marketing of products for reproductive and menopausal needs. Currently, Duramed markets 27 proprietary pharmaceutical products.

Barr Pharmaceuticals, Inc.

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