FDA clears First Response Gold Digital Pregnancy Test

Published on March 4, 2014 at 8:22 AM · No Comments

Church & Dwight Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the First Response™ Gold™ Digital Pregnancy Test to determine if a woman is pregnant up to six (6) days before her missed period and with over 99% accuracy from the day of her expected period – a significant step in pregnancy test innovation. In addition, the First Response™ Early Result Pregnancy Test, which was previously cleared to determine if a woman is pregnant up to 6 days before her missed period, has also been FDA-cleared to detect pregnancy with over 99% accuracy from the day of her expected period.

First Response is now the only pregnancy test brand that can tell a woman that she is pregnant one day sooner than any other at-home pregnancy test, allowing her to initiate prenatal care as close to conception as possible. According to a recent survey conducted by First Response, 85% of women feel that technology that is able to detect pregnancy 6 days before her missed period is important. Additionally, 92% of women surveyed feel that technology that is 99% accurate from the day of her expected period is a priority.

"A pregnancy test with results this early and with this level of accuracy from the day of the expected period helps alleviate a woman's anxiety and help her make the best choices for herself," said Dr. Mary Jane Minkin, Clinical Professor of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine. "I am excited to see this advancement as it strongly encourages women to practice a healthier lifestyle sooner in the critical first stages of a baby's development."

First Response continues its leadership as the #1 at-home pregnancy test brand in the United States with these new groundbreaking claims.

  • The First Response™ Gold™ Digital Pregnancy Test has been reformulated to include a new antibody to detect an additional form of the pregnancy hormone (hCG beta core fragment or hCG βcf) that is present throughout pregnancy.  Detection of this additional form of the pregnancy hormone, when combined with optimization to the proprietary First Response™ Gold™ Digital Pregnancy algorithm, allows it to be the first at-home digital test cleared by the FDA to detect pregnancy as early as six (6) days before the day of the missed period with over 99% accuracy from the day of the expected period.
  • The First Response™ Early Result Pregnancy Test which was previously cleared to determine if a woman is pregnant up to 6 days before her missed period, has been reformulated to detect the hCG beta core fragment.  It has also been optimized to detect pregnancy with over 99% accuracy from the day of the expected period. 

"At First Response, we are committed to reducing the anxiety women face when it comes to pregnancy and the family planning process, and addressing an important consumer need through our innovative products and technology," said Stacey Feldman, Vice President of Marketing, Church & Dwight. "With more than 25 years of innovation, First Response continues to answer a woman's most important questions – telling her whether she is pregnant sooner than any other brand on the market and with 99% accuracy from the day of a woman's expected period."

First Response is dedicated to providing women everywhere with the most accurate reproductive health information, and today is announcing the availability of their new, global smartphone app, the First Response Tracker. The new app offers  four essential tools to help women track their reproductive health, including a personalized Period Tracker, Ovulation Tracker, "How Far Along Am I?" Pregnancy Tracker and Due Date Calculator. The First Response Tracker eliminates guesswork by predicting a woman's next period, calculating her most fertile days, estimating how far along she is once she is pregnant and predicting her due date.

Source:

First Response

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