NOWDiagnostics Inc. Begins Manufacturing New Point-of-Care Tests Capable of Providing Results in Just Minutes with the Same Reliability as Lab-Based Tests
'A lab at the tip of your finger': New technology is the first of its kind to utilize only a single drop of capillary or whole blood
SPRINGDALE, Ark., July 22, 2015 /PRNewswire/ -- NOWDiagnostics Inc., based in Springdale, Ark., has created a line of unique blood-based rapid tests that will enable medical professionals to conduct simple-to-use, highly accurate tests for a variety of ailments and diseases. The company is currently developing its ADEXUSDx™ product pipeline consisting of 50+ tests in a variety of categories, including food intolerance, common infectious disease, STDs, cardiology, toxicology and screening (from thyroid dysfunction to vitamin D deficiency and pregnancy)
The tests allow for a one-step process that provides results in five to 15 minutes using only a single drop of whole or capillary blood with no laboratory needed. NOWDiagnostics recently received U.S. Food and Drug Administration registration to manufacture and market under the ADEXUSDx™ brand name. NOWDiagnostics' Springdale, Ark., facility was officially registered with the FDA in December 2014 and is currently manufacturing the ADEXUSDx™ hCG test for distribution in the United States and five other tests for distribution in Europe.
"The broader implications for this technological breakthrough are game changing," said Kevin Clark, chief executive officer of NOWDiagnostics. The tests have the potential to revolutionize current medical test protocol and to lower costs to insurance companies and, ultimately, consumers. In addition, these tests can reduce consumer anxiety by providing results in only minutes.
"Waiting on lab results for days is highly inefficient for any clinic or hospital," Clark said. "The immediacy of this technology could truly impact the health care industry by saving time and avoiding unnecessary delays in beginning treatment, and possibly lowering liability for the caregiver. It could also help point-of-care medical channels create new revenue streams in the projected $60 billion in-vitro diagnostic industry."
The traditional blood testing model requires a larger blood draw by a professionally trained phlebotomist or several drops of whole blood collected in a smaller tube. In either case the blood sample is then shipped off to a reference laboratory. Both the physician and the patient can wait days for a diagnosis and to begin treatment. NOWDiagnostics changes that model.
The sensitivity, specificity, accuracy and precision of the NOWDiagnostics tests are proving as reliable as tests performed in a full-scale lab, yet ADEXUSDx tests require a remarkably small sample size of blood, only a single drop.
Six WO patents have been granted, and an additional three WO patent applications have been filed. Six tests are available for sale in Europe today (hCG [pregnancy], two cardiac [heart attack] tests and three toxicology tests). A third cardiac marker test is expected to complete the NOWDiagnostics cardiac panel for Europe by 2016. The hCG whole blood pregnancy test has recently received 510(k) clearance by the FDA for distribution in the United States under the ADEXUSDx brand name.
"The tests we have available are changing how and when healthcare decisions are being made – important timely decisions that can save lives," said Jeremy Wilson, chairman of NOWDiagnostics. "Our rapid tests provide fast, efficient and reliable test results all through one small device and with no extra processes, which we believe will change healthcare in this country and abroad."
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.
Contact:
Natalie Ghidotti, APR
Ghidotti Communications
501.837.0206
[email protected]
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SOURCE NOWDiagnostics Inc.
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