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First Response test gains FDA approval for earlier pregnancy detection
March 4th, 2014
EWING, N.J. – The Food and Drug Administration has cleared an enhanced First Response Gold Digital Pregnancy Test that manufacturer Church & Dwight Co. said can tell a woman she's pregnant a day sooner than any other at-home pregnancy test.
The company said Tuesday that the FDA has approved the First Response Gold Digital Pregnancy Test to determine if a woman is pregnant up to six days before her missed period and with over 99% accuracy from the day of her expected period.
In addition, the First Response Early Result Pregnancy Test, previously cleared to determine if a woman is pregnant up to six days before her missed period, has also been approved by the FDA to detect pregnancy with over 99% accuracy from the day of her expected period, according to Church & Dwight.
The First Response Gold Digital Pregnancy Test was reformulated to include a new antibody to detect another form of the pregnancy hormone (hCG beta core fragment) that's present throughout pregnancy. Church & Dwight said the detection of this additional form of the pregnancy hormone, when combined with optimization to the proprietary First Response Gold Digital Pregnancy algorithm, enables it to be the first at-home digital test cleared by the FDA to detect pregnancy as early as six 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 six days before her missed period, also has been reformulated to detect the hCG beta core fragment and is now optimized to detect pregnancy with over 99% accuracy from the day of the expected period, the company added.
"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," stated Stacey Feldman, vice president of marketing at 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."
Church & Dwight noted that the earlier pregnancy detection capability enables women to being prenatal care as close to conception as possible. According to a recent poll of 1,000 women conducted by First Response, 85% of women feel that technology that is able to detect pregnancy six days before her missed period is important. Also, 92% of women surveyed feel that technology that's 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," according 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."
Also on Tuesday, First Response announced a new smartphone application, the First Response Tracker. The new mobile app offers four key tools to help women track their reproductive health: the personalized Period Tracker, the Ovulation Tracker, the "How Far Along Am I?" Pregnancy Tracker and the Due Date Calculator. The free app will be available in early April for all iPhone and Android phones and can also be downloaded at KnowSooner.com.