Compelo Medical Devices is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

Church & Dwight receives FDA approval for its new enhanced pregnancy test

Church & Dwight has obtained the US Food and Drug Administration (FDA) approval for its First Response Gold digital pregnancy test, designed 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.

Church & Dwight has also announced that the FDA has approved the First Response early result pregnancy test to detect pregnancy with over 99% accuracy from the day of her expected period. Previously the test has been approved by the FDA to determine if a woman is pregnant up to six days before her missed period.

According to Church & Dwight, 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.

Church & Dwight has reformulated First Response Gold digital pregnancy test to include a new antibody to detect an additional form of the pregnancy hormone (hCG beta core fragment or hCG ßcf) that is present throughout pregnancy.

Detection of the additional form of the pregnancy hormone, when combined with optimization to the 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 over 99% accuracy from the day of the expected period.

Church & Dwight marketing vice president Stacey Feldman noted the company is committed to reducing the anxiety women face when it comes to pregnancy and the family planning process, and addressing an important consumer need through its innovative products and technology.

"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," Feldman added.

First Response is announcing the availability of its new First Response Tracker global smartphone app, which 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.

This application will be available for free in early April 2014 for all iPhone and Android phones.