Rapid, finger-stick test is first over-the-counter (OTC), blood-based pregnancy test for sale in a European Union member country
NOW Diagnostics Inc. announced today the over-the-counter (OTC) availability of its rapid, accurate, FIRST TO KNOWfinger-stick pregnancy test in Italy.
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 Pharma.
"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 coming months."
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 Mark process.
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 visit www.welcomepharma.com
NOW Diagnostics Company Contact
Jeff Ellis, 479-966-4540
VP Sales Marketing
NOW Diagnostics Media Contact
Armada Medical Marketing
Dan Snyders, 720-231-9990