Rapid, finger-stick test is first over-the-counter (OTC), blood-based
pregnancy test for sale in a European Union member country
FIRST TO KNOW® is the first OTC, blood-based pregnancy test
for sale anywhere in the European Union. The test is now available at
pharmacies in Italy through an exclusive distribution agreement with Welcome
“We’re offering a new choice in OTC pregnancy tests to women in the
Italian market,” said Gianni Furino, CEO of NOW Diagnostics Europe.
“FIRST TO KNOW® is reliable, affordable, easy-to-use and
proven to be highly accurate, without guessing or re-testing. We intend
to expand the availability of this test across the European Union in the
Pregnancy tests are based on the detection of human chorionic
gonadotropin (hCG) in blood or urine. Unlike urine-based OTC pregnancy
tests sold in Europe, NOW Diagnostics’ FIRST TO KNOW® test
uses an advanced finger-stick method to determine pregnancy using a
single droplet of blood.
“Through our partnership with NOW Diagnostics, we’re proud to deliver
this simple yet high-tech test to Italian pharmacies,” said Giuseppe
Paradisi, CEO of Welcome Pharma. “Women want to know their results as
soon as possible, as accurately as possible, with a test that can be
done at the pharmacy or in the privacy of one’s own home, and that’s
exactly what FIRST TO KNOW® delivers.”
The first registered product of the ADEXUSDx® family of
products, NOW Diagnostics’ hCG pregnancy test is branded and marketed in
Europe under the FIRST TO KNOW® trademark and distributed in
Italy by Welcome Pharma. The ADEXUSDx® test platform has
undergone a rigorous regulatory process in the U.S., receiving 510(k)
clearance, CLIA registration and classification by the U.S. Food and
Drug Administration for use in a professional setting, and it recently
received the EC
Design Examination Certificate as part of the EU conformity and CE
FIRST TO KNOW® offers women a new, more reliable choice in
pregnancy testing with more than 99%
sensitivity and specificity compared to a laboratory test. The test
is easy to handle and comes with simple, step-by-step instructions, so
women can be sure they have an accurate reading the first time. Pricing
of the FIRST TO KNOW® pregnancy test in Italy is comparable
to most urine-based OTC pregnancy tests currently on the market in Italy.
The FIRST TO KNOW® pregnancy test is not FDA-cleared for OTC
sale or for home use in the U.S.
About NOW Diagnostics, Inc.
NOW Diagnostics Inc., based in Springdale, Arkansas, is a leader in
innovative diagnostics testing. Its ADEXUSDx®
product line features a lab at your fingertip, using a single drop of
blood to test for a variety of common conditions, illnesses, and
diseases with results in a matter of minutes. By eliminating the need to
send tests to off-site laboratories, NOW Diagnostics has the potential
to decrease the waiting period to determine test results by days. NOW
Diagnostics’ Springdale, Arkansas facility was officially registered
with the U.S. Food and Drug Administration in December 2014. NOW
Diagnostics is currently offering an hCG (pregnancy) test in the United
States and Europe as well as three cardiac (heart attack) tests and
three toxicology tests in Europe. For more information about NOW
Diagnostics, visit www.nowdx.com.
For more information about the ADEXUSDx® hCG pregnancy test,
including, among other things, its intended use, features, benefits and
limitations, and directions for use, visit http://www.nowdx.com/products/hcg.
For more information on the FIRST TO KNOW® pregnancy test, including,
among other things, its intended use, features, benefits and
limitations, and directions for use, visit www.firsttoknow.eu.
About Welcome Pharma SpA
Operating since 1997, Welcome Pharma partners with pharmaceutical and
consumer companies for the marketing and distribution of products in
pharmacies (across Italy). Its comprehensive service and solid sales
network guarantees 100 percent national coverage between cooperatives
and wholesalers, supplying more than 7000 select pharmacies with a
reorder rate of over 90 percent. For more information on Welcome Pharma