Supplier News Breaks Archives
Church & Dwight gets FDA OK for early pregnancy test
January 28th, 2010
PRINCETON, N.J. – The Food and Drug Administration has cleared the First Response Early Result Pregnancy Test, which manufacturer Church & Dwight Co. said can determine pregnancy up to six days before the day of a woman's missed period.
Church & Dwight said Wednesday that the test has patent-pending technology that can accurately detect the pregnancy hormone human chorionic gonadotropin (hCG) in a woman's urine up to six days before the day of a missed period — one day before any other at-home pregnancy test available on the market.
According to the company, hCG begins to appear in a pregnant woman eight to 10 days after fertilization, and the amount of hCG doubles every 36 to 48 hours as the pregnancy progresses. First Response's patent-pending Polymeric Amplification Technology (PAT) has increased the sensitivity of the testing device and can detect the pregnancy hormone at lower levels than ever before, Church & Dwight noted.
"A pregnancy test with results this early sets the stage for a healthy baby and a healthy mother. This latest advancement means pregnant women can initiate a healthier lifestyle even sooner in the critical first stages of a baby's development," Dr. Mary Jane Minkin, a board-certified obstetrician/gynecologist in New Haven, Conn., and a Clinical Professor of Obstetrics and Gynecology at Yale University School of Medicine, said in a statement released by Church & Dwight. "Women who want results quickly will undoubtedly have less anxiety when taking this at-home test."
The new test will expand the First Response product lineup, which includes First Response Gold Digital, First Response Rapid Result Pregnancy Test, First Response Easy Read Ovulation Test, First Response Daily Ovulation Test, First Response Fertility Test for Women, and Answer Pregnancy and Ovulation Tests.