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NOW Diagnostics’ Whole Blood, Rapid Pregnancy Test Performance Comparable to Standard Lab Tests in UCLA Field Comparison

NOW Diagnostics,Inc.
Posted on: 03 Oct 17

Initial field evaluations of the whole blood ADEXUSDx® point-of-care (POC) hCG pregnancy test from NOW Diagnostics, Inc. (NOWDx) have provided additional evidence of the test’s accuracy and performance in healthcare settings such as surgery centers, urgent care and emergency departments.

Testing conducted by the Department of Pathology and Laboratory Medicine, University of California, Los Angeles (UCLA), using NOWDx’s FDA-cleared, rapid point-of-care (POC) pregnancy test was able to accurately identify pregnancy hormone (hCG) levels in droplet-volume blood samples compared to a standard, laboratory-based blood test.

“The ADEXUSDx® hCG test assayed in the UCLA study accurately identifies blood samples with hCG levels above 10 mIU/mL,” said research co-author Omai B. Garner, Ph.D., UCLA Department of Pathology. “The test would offer improved turnaround time without sacrificing sensitivity or specificity as compared to urine point-of-care testing.”

As reported in the September 2017 issue of the Journal of Applied Laboratory Medicine, researchers found that “the use of blood instead of urine, the decreased time to diagnosis, and the improved lower limit of detection (10 vs 20 mIU/mL)” were key factors that could result in improved clinical outcomes associated with missed or delayed pregnancy diagnosis.i In addition to providing an opportunity for improved care for women of child-bearing age, researchers also stated, “the ADEXUSDx® hCG test represents a valuable and unprecedented alternative to a laboratory-based assay in settings where diagnostic and laboratory services are unavailable.”i

Urine tests have shown susceptibility to analytical interference, which can result in false negatives. These false negatives are particularly impactful when a pregnant woman is about to undergo a procedure that could be harmful to a developing fetus, and a delayed or inaccurate diagnosis can lead to significant morbidity, mortality and increased health care costs. Blood has proven to be a more sensitive and accurate medium than urine in general, enabling more reliable results. The UCLA field evaluations determined that the ADEXUSDx® test is an acceptable method for blood-based, POC testing.

“These field evaluations conducted by UCLA prove that our simple-to-use rapid point-of-care ADEXUSDx® hCG pregnancy test is an acceptable alternative to laboratory based tests,” said Kevin Clark, CEO of NOW Diagnostics, Inc. “We are thrilled to partner with this widely respected institution in this evaluation.”

The ADEXUSDx® hCG pregnancy test allows for a one-step process using lateral-flow technology. The test provides results in ten minutes, using as little as a single drop of capillary or venous blood with no laboratory or equipment needed. Because hCG serum testing is the standard of care for large laboratories, UCLA tested the ADEXUSDx® hCG pregnancy test against the Roche hCG + β 2-site immunocentric sandwich assay.

NOWDx manufactures and sells a unique line of blood-based rapid tests that allow health care providers to conduct simple, highly accurate tests at the bedside for a variety of conditions. Currently, NOWDx manufactures the ADEXUSDx® hCG test for distribution in the United States and abroad.

ADEXUSDx® is cleared as a moderately complex test by the United States Food and Drug Administration (FDA) for hCG measurement in capillary blood, venous blood, heparinized plasma and serum.

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 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, NOW Diagnostics™ has the potential to decrease by days the waiting period to determine test results. NOW Diagnostics™ is currently offering an hCG (pregnancy) test in the United States and Europe, and three cardiac (heart attack) tests and three toxicology tests in Europe. Additional tests are in the development pipeline, including sexually transmitted diseases, more cardiac markers (heart attack), food intolerances, common infectious diseases and a variety of screening tests. For more information about NOW Diagnostics™, 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.

i Clinical Comparison of the NOWDiagnostics' ADEXUSDx Human Chorionic Gonadotropin Point-of-Care Test with the Roche Elecsys hCG + β2 for the Serum Measurement of Human Chorionic Gonadotropin. The Journal of Applied Laboratory Medicine: An AACC Publication. 2017;:jalm.2017.023077.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170928005425/en/

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Last updated on: 03/10/2017

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