AmniScreen Amniotic Fluid Detection Device Now Available
Montvale, NJ - Barr Pharmaceuticals, Inc. recently announced the launch of AmniScreen, the first and only FDA-approved at-home screening test for amniotic fluid leakage during pregnancy. AmniScreen is a prescription-only panty liner device that includes a proprietary polymer-coated polyester strip designed to detect amniotic fluid leakage, which could indicate a potential problem with a pregnancy. Barr's proprietary subsidiary, Duramed Pharmaceuticals, Inc., will detail AmniScreen to physicians and healthcare providers with its Specialty and Institutional Sales Forces.
"AmniScreen may offer reassurance to women concerned about unexplained vaginal wetness during pregnancy. The product detects amniotic fluid leakage that can lead to serious complications, such as infection and preterm labor,(1)" says Nancy Jasper, MD, Assistant Clinical Professor, Department of Ob/Gyn, Columbia University, College of Physicians and Surgeons. "It's important for women to know when wetness may be caused by amniotic fluid leakage."
In July 2006, Barr announced that it had entered into a development, manufacturing and supply agreement with Common Sense Ltd. for AmniScreen. Under the terms of the agreement, the Company agreed to make a one-time payment to Common Sense following FDA approval.
Common Sense will manufacture and package the product and Duramed will detail to physicians and healthcare providers. Barr will record net sales of the product and will pay Common Sense for product delivered.
How AmniScreen Works
AmniScreen works by detecting elevated pH levels, which may indicate amniotic fluid leakage.(2) Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.(3) The pivotal trial demonstrated that AmniScreen detected amniotic fluid leakage about 96% of the time.(4) During the trial, patient-read results and clinician-read results matched more than 97% of the time.(5)
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 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. pH levels greater than or equal to 5.2 produce 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.
(1) DeCherney et. al; Current Obstetric & Gynecologic Diagnosis & Treatment. Chapter 15, Pg. 279
(2) AmniScreen Prescribing Information
(3) AmniScreen Prescribing Information
(4) AmniScreen Prescribing Information
(5) AmniScreen Prescribing Information
SOURCE: Barr Pharmaceuticals, Inc.