March 29, 2017 7:40 AM ET

Healthcare Equipment and Supplies

Company Overview of NOWDiagnostics, Inc.

Company Overview

NOWDiagnostics, Inc. manufactures and sells blood-based rapid tests. It offers diagnostic test kits in Europe. It has strategic alliances with Zalgen Labs LLC. The company was formerly known as HomeDx, Inc. and changed its name to NOWDiagnostics, Inc. in March 2013. The company was incorporated in 2013 and is based in Springdale, Arkansas.

1200 Stewart Place

Springdale, AR 72764

United States

Founded in 2013

Phone:

479-966-4530

Key Executives for NOWDiagnostics, Inc.

Chief Executive Officer
Age: 53
Founder and Chairman
Chief Financial Officer and Chief Administrative Officer
Executive Director
Age: 50
Director of Production
Compensation as of Fiscal Year 2016.

NOWDiagnostics, Inc. Key Developments

Zalgen Labs LLC and NOWDiagnostics Inc. Announce Strategic Collaboration to Advance Novel Rapid Diagnostic Tests for Tropical Diseases

Zalgen Labs LLC (Zalgen) announced that it has entered into a series of agreements with NOWDiagnostics Inc. (NOWDx) to collaborate in the development, manufacturing and commercialization of infectious disease diagnostic products. Under the terms of the agreements, the parties will collaborate in bringing new rapid infectious disease tests to the global market, primarily using the patented NOWDx ADEXUSDx® test system. NOWDx will also manufacture existing Zalgen products, including the ReEBOV® Antigen Rapid Test for Ebola virus and the ReLASV™ Antigen Rapid Test for Lassa fever. The ReEBOV® Antigen Rapid Test for Ebola was the first RDT and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus, and also the first listed for procurement by the World Health Organization (WHO) under the Emergency Use Assessment and Listing procedure. The NOWDx alliance expands the VHFC portfolio with an advanced diagnostic RDT platform for additional products currently in development.

NOWDiagnostics Inc. Announces Executive Appointments

NOWDiagnostics Inc. announced the addition of three new members to its leadership team: Ann G. Bordelon as Chief Financial Officer and Chief Administrative Officer, Jeff Ellis as the Director of Sales and Marketing and Adam Glasier as Director of Finance. Before joining the company, Ann Bordelon spent nearly 13 years with Walmart. During her time she served as Chief Financial Officer for Walmart's Sam's Club division and CFO of the Asia region. Jeff Ellis has spent his entire career in sales and sales management. Ellis served as Vice President of Sales for Alere's Hospital Division, Vice President of Marketing for the Alere Cardiac Division and then transitioned to running the U.S. Sales Division for one of Alere's partners, Chembio Diagnostics. Adam Glasier worked previously at Walmart in the finance and strategy group of the U.S. business division where he was responsible for analysis and execution of strategic initiatives and financial planning.

Nowdiagnostics Inc. Receives FDA Clearance for Adexusdx™ hCG Test

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. 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.

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