C&D gets FDA clearance for advanced pregnancy test kit, launches new app

EWING, N.J. — Church & Dwight on Tuesday announced that the Food and Drug Administration has cleared the First Response Gold Digital Pregnancy Test to determine if a woman is pregnant up to six days before her missed period and with more than 99% accuracy from the day of her expected period. In addition, 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 FDA-cleared to detect pregnancy with more than 99% accuracy from the day of her expected period. 

In addition to the FDA clearance, First Response also announced the availability of their new, global smartphone app, the First Response Tracker. The new app offers four 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. The app will be available for free in early April for all iPhone and Android phones, or available for download at www.KnowSooner.com.

The First Response Gold Digital Pregnancy Test has been reformulated to include a new antibody to detect an additional form of the pregnancy hormone (i.e., 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 days before the day of the missed period with more than 99% accuracy from the day of the expected period.

“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,” stated 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 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, C&D noted. According to a recent survey conducted by First Response, 85% of women feel that technology that is able to detect pregnancy six 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.