NOWDiagnostics Wins FDA Approval for ADEXUSDx hCG Test
Published: Aug 13, 2015
SPRINGDALE, Ark., Aug. 12, 2015 /PRNewswire/ -- NOWDiagnostics' ADEXUSDx hCG point-of-care test, which uses only a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests, has now been CLIA registered and classified by the U.S. Food and Drug Administration. The new hCG test is the first single-step, capillary blood hCG test requiring no equipment to receive FDA 510(k) clearance.
The ADEXUSDx hCG Test, NOWDiagnostics' first FDA-cleared test available in the United States, is an immunoassay used for the qualitative detection of human chorionic gonadotropin (hCG) in human whole blood, plasma or serum. The test is an early detection aid for pregnancy for health care professionals in a variety of clinical and critical care settings. Depending on the woman and her pregnancy, the ADEXUSDx hCG test can detect pregnancy approximately two to eight days earlier than commonly available urine-based tests. The ADEXUSDx hCG test results are available 10 minutes after the test is used.
Early detection of pregnancy is important for caregivers in order to avoid certain medications and procedures that could harm a fetus. Unfortunately, clinics across the country are experiencing too many false-negative results from point-of-care urine-based tests. In a March 2015 report in Clinical Chemistry, Robert N. Nerenz and Ann M. Gronowski detailed their evaluation of 11 common POC hCG urine-based devices and determined that 9 of the 11 were susceptible to false-negative results.
"It's too important for the safety of the mother and fetus to not have accurate pregnancy results in our emergency rooms and clinics," said Kevin Clark, president and chief executive officer of NOWDiagnostics Inc. "Our hCG test can save lives and reduce liability for health care providers."
NOWDiagnostics' ADEXUSDx product line is reinventing how diagnostics are performed. The patented technology allows physicians to easily and accurately receive results within minutes by using a single drop of capillary or whole blood. Testing is a single-step process that can identify common conditions, illnesses and diseases with the same or better accuracy, sensitivity, specificity and precision as a predicate device in a full-scale lab. The diagnostic test kits can be processed in as little as five to 15 minutes, onsite in-clinic and by staff technicians and nurses.
"We see a great opportunity to save hospitals and clinics time, money and resources by providing them a lab in the palm of their hands," Clark said.
ABOUT NOWDIAGNOSTICS INC.
NOWDiagnostics Inc., based in Springdale, Ark., is a leader in innovative diagnostics testing. Its ADEXUSDx product line features a lab at your fingertip, using only 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, NOWDiagnostics can decrease by days the waiting period to determine test results. The company is currently offering an hCG (pregnancy) test in the United States and Europe, and two cardiac (heart attack) tests and three toxicology tests in Europe. Additional tests are in the development pipeline, including sexually transmitted diseases, more cardiac (heart attack), food intolerances, common infectious diseases and a variety of screening tests. NOWDiagnostics is funded by Bentonville, Ark.-based NewRoad Ventures, a company investing in emerging companies in a variety of growing industries, including retail, consumer packaged goods, health and wellness, data, e-commerce, environmental water quality and logistics. For more information about NOWDiagnostics, visit www.nowdx.com. For more information about the ADEXUSDx hCG test, including, among other things, its intended use, features, benefits and limitations, and directions for use, visit http://www.nowdx.com/products/hcg.
Natalie Ghidotti, APR
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SOURCE NOWDiagnostics Inc.