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FDA Clears Single Blood Drop Test for Earlier Pregnancy Detection

NOWDiagnostics‘ 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.

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 healthcare 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.

Source: Medical Design Technology News and NOWDiagnostics