New Clearblue Advanced Pregnancy Test with Weeks Estimator Features First of
Its Kind Technology That Indicates Pregnancy and Estimates Weeks
New Test Gives Women Two Essential Answers and More Information Than They Have
Ever Had Before
CINCINNATI -- May 6, 2013
At the 61st Annual Clinical Meeting of the American Congress of Obstetricians
and Gynecologists (ACOG) in New Orleans, Clearblue unveiled the newest
addition to their family of products that will change women’s home pregnancy
test experiences forever. Cleared by the Food and Drug Administration (FDA),
the new Clearblue Advanced Pregnancy Test with Weeks Estimator not only tells
a woman if she is pregnant but also estimates the number of weeks since
ovulation (when egg is released to be fertilized by sperm).
“Confirming pregnancy is a life-changing moment in any woman’s life, and it
sparks so many immediate questions like when did I get pregnant? That’s why we
are thrilled to be able to bring the new Clearblue Advanced Pregnancy Test
with Weeks Estimator to women in the United States,” said Kirsten Suarez,
Clearblue brand manager. “This test was created based on years of qualitative
and quantitative consumer research and a clear understanding that a woman
wants as much information as possible as soon as she receives a positive
result. The Clearblue Advanced Pregnancy Test with Weeks Estimator gives her
more information right at the beginning of this new phase in her pregnancy
journey than she’s ever had before.”
Currently, the majority of physicians estimate weeks of pregnancy using a
formula based on a woman’s last menstrual period. However, one in six women do
not have a last menstrual period recorded^1 and approximately 70 percent are
uncertain of their last menstrual period.^2
The Clearblue Advanced Pregnancy Test with Weeks Estimator uses new technology
that takes two measurements instead of one and not only gives an accurate
pregnancy result but also estimates the number of weeks since ovulation. The
test is more than 99 percent accurate in detecting pregnancy from the day of
the expected period, and it is approximately 93 percent accurate in estimating
how many weeks based on time since ovulation^3. All results should be
confirmed by a doctor, especially when making decisions about future medical
“The new Clearblue Advanced Pregnancy Test with Weeks Estimator is an exciting
innovation that clearly demonstrates the amazing advancements we’ve made in
this category over the last 30 years,” said Michael Zinaman, MD. “While women
must still make appointments with their physicians to confirm, date and
monitor pregnancy, this test provides women and their physicians with valuable
information from the very beginning of pregnancy, more than any other test
How It Works
All home pregnancy tests are designed to detect the hormone hCG in urine to
determine pregnancy. However, the Clearblue Advanced Pregnancy Test with Weeks
Estimator also measures the concentration of hCG, which helps estimate when
fertilization occurred. If the test is positive, ‘Pregnant’ will be clearly
indicated in words on the display along with an estimate of how many weeks
have occurred since ovulation: 1-2 weeks, 2-3 weeks or 3+ weeks.
The launch of this product is supported by a wealth of clinical data. A
multi-center, prospective study was conducted in the US to evaluate the Weeks
Estimator results. Women were recruited pre-conception, providing 153
pregnancies for analysis. In this study, agreement between Clearblue Advanced
Pregnancy Test with Weeks Estimator results and time since ovulation (when the
egg is released to be fertilized by sperm) was 93% ^ 3.
The Clearblue Advanced Pregnancy Test with Weeks Estimator will be available
in stores and online in September 2013. This will be the second product
innovation added to the Clearblue product portfolio this year as the Clearblue
Advanced Digital Ovulation Test, the first and only test that typically
identifies 4 fertile days, was introduced in early 2013.
Indications for Use
The Clearblue Advanced Pregnancy Test with Weeks Estimator is an
over-the-counter urine hCG test which is intended for the detection of
pregnancy. The test detects hCG in some cases from 4 days before the expected
period (which is 5 days before the day of the missed period). The test is only
intended for individual use at home. It is not intended for use in a
healthcare setting. This test contains a Weeks Estimator. The Weeks Estimator
is meant solely as an estimate for the consumer and is not intended as a
substitute for a doctor’s clinical diagnosis. The Weeks Estimator is not
intended for multiple pregnancies. The estimate provided by the device may be
inaccurate in these cases. This test cannot be used to determine the duration
of pregnancy or to monitor the progression of pregnancy. Your doctor
determines how many weeks pregnant you are based on the first day of your last
menstrual period and ultrasound results. This test provides a different
estimate that cannot be substituted for a doctor’s determination of
gestational age. Only your doctor can monitor pregnancy progression. You
should seek qualified prenatal care if you suspect you are pregnant.
Always read full information on pack and package insert before use.
Clearblue is the world’s leading brand in home pregnancy and fertility
testing. The Clearblue product range is built on a strong foundation of
peer-reviewed science and consumer understanding. Clearblue products are also
trusted and recommended by doctors, many of whom recognize that Clearblue is
supported by 25 years of expertise, quality, and innovation in consumer
diagnostics. Clearblue offers a complete line of products to help a woman
better understand her body’s ovulation cycle and identify peak fertility days
to maximize her chances of getting pregnant. The Clearblue family of products
includes the Clearblue Fertility Monitor, Clearblue Advanced Digital Ovulation
Test, Clearblue Digital Ovulation Test, Clearblue Ovulation Test, Clearblue
Easy Ovulation Combination Pack, Clearblue Digital Pregnancy Test, and
Clearblue PLUS Pregnancy Test. For more information visit
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^1 Buekens P (1984) J Epidemiol Community Health 38:79-80.
^2 Geirsson RT (1991) Br J Obstet Byenecol 98:108-109.
^3 Average 93% agreement across the Weeks Estimator result categories when
compared to ovulation (LH Surge +1), with a range of 84-97%.
Andy Sullivan, 513-622-5299
MSL New York
Sarah List, 646-500-7946
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