SPRINGDALE, Ark.--(BUSINESS WIRE)--NOW Diagnostics Inc. announced today it has received the EC Design Examination Certificate, allowing its ADEXUSDx® hCG pregnancy test to be sold over-the-counter (OTC) throughout the European Union. The EC Design Examination Certificate is part of a European Community conformity assessment procedure that verifies and attests to the technical design of the product.
“Obtaining this certificate makes possible the first ever droplet-volume, blood-based pregnancy test for over-the-counter sale throughout the European Union,” said Kevin Clark, Chief Executive Officer of NOW Diagnostics. “The ADEXUSDx® hCG pregnancy test, which provides for quicker and more reliable results than urine-based OTC pregnancy tests, will soon be available for purchase directly by consumers. When available, the ADEXUSDx® hCG pregnancy test may be performed at a pharmacy or at home.”
Pregnancy tests are based on the detection of human chorionic gonadotropin (hCG) in blood or urine. Unlike urine-based pregnancy tests, NOW Diagnostics’ ADEXUSDx® hCG pregnancy test uses an easy-to-handle, finger-stick method with a tiny lancet and lateral-flow cartridge technology to test capillary blood. The ADEXUSDx® hCG pregnancy test is highly accurate and provides results in ten minutes, diagnosing pregnancy with more than 99% sensitivity and specificity as compared to a laboratory test. The ADEXUSDx® hCG pregnancy test is expected to be available for sale to European consumers by May 2018.
“We believe that Europe, with its top-of-license pharmacy model, is an ideal market for this test,” added Clark. “The ADEXUSDx® hCG pregnancy test will give European consumers access to an easy-to-use, blood-based test, which provides results of pregnancy status quicker and more reliably than urine-based OTC pregnancy tests.”
This quickness, reliability and convenience is extremely important, because pregnancy can necessitate lifestyle changes for the mother such as reducing or eliminating the consumption of caffeine, alcohol, artificial sweeteners and certain foods.
The ADEXUSDx® hCG pregnancy test, a CLIA moderate complexity test, has been widely adopted in health care settings across the U.S., including surgery centers, urgent care clinics and emergency departments, where an accurate determination of the patient’s pregnancy status is of paramount importance. The ADEXUSDx® hCG pregnancy test is not FDA-cleared in the U.S. for OTC sale or for home use.
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.
