Now Diagnostics Inc, Springdale, Ark, has received the EC design examination certificate for the company’s AdexusDx human chorionic gonadotropin (hCG) pregnancy test, permitting the test to be sold over the counter 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,” says 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.”
Kevin Clark, Now Diagnostics.
Pregnancy tests are based on the detection of hCG in blood or urine. Unlike urine-based pregnancy tests, the AdexusDx hCG pregnancy test uses a fingerstick method with a tiny lancet and lateral-flow cartridge technology to test capillary blood. The test is highly accurate and provides results in about 10 minutes, diagnosing pregnancy with more than 99% sensitivity and specificity as compared to a laboratory test.
The quickness, reliability, and convenience of the test 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.
“We believe that Europe, with its top-of-license pharmacy model, is an ideal market for this test,” says 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.”
The AdexusDx hCG pregnancy test is classified as a moderate complexity test under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The test has been widely adopted in US healthcare settings, including emergency departments, surgery centers, and urgent care clinics, where an accurate determination of the patient’s pregnancy status is paramount. In the United States, the AdexusDx hCG pregnancy test is not cleared for OTC sale or home use.
For more information, visit Now Diagnostics.
