SPRINGDALE, Ark. & GERMANTOWN, Md.--(BUSINESS WIRE)--NOWDiagnostics Inc. (NOWDx), an innovator in rapid diagnostic tests (RDTs), and Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, announced that the first hemorrhagic fever diagnostic products co-developed in the unique NOWDx ADEXUSDx® format have advanced to clinical testing in several sites in West Africa.
The parties are developing new rapid tests that detect infectious diseases for the global market, primarily using the patented NOWDx ADEXUSDx® test system. The first two products being tested include rapid tests for Ebola and Lassa viruses.
Zalgen is a partner of the Viral Hemorrhagic Fever Consortium (VHFC), an academic and industry partnership led by Tulane University, developing state-of-the-art diagnostic and immunotherapeutic products for biothreat agents and emerging pathogens.
"We are excited to begin testing of the first products from our collaboration with Zalgen and the VHFC,” said Kevin Clark, CEO of NOWDiagnostics. “We look forward to advancing these and additional tests on our advanced diagnostic RDT platform directed against high-risk diseases that have a devastating impact on communities across the globe.”
The ADEXUSDx® platform uses as little as a single drop of blood to produce a positive or negative result. It uses a single-use lancet, just like a diabetic might use for a blood glucose test. Previously, testing has been limited to large and expensive laboratory machines. The traditional testing method presents obvious logistical challenges for remote populations who may live hours from a medical facility. The goal is to bring the diagnoses as close to the patient as possible – even in very remote locations.
Zalgen currently commercializes a wide range of hemorrhagic fever diagnostic tests, 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 the Ebola virus, and also the first listed for procurement by the World Health Organization (WHO) under the Emergency Use Assessment and Listing procedure.
“Our product development collaboration with NOWDiagnostics is significantly ahead of schedule,” said Zalgen Director of Diagnostic Development Matt Boisen, Ph.D. “Zalgen and the VHFC plan to continue building on our portfolio of diagnostic products for hemorrhagic fevers and other tropical diseases, and the ADEXUSDx® cassette is the ideal immunodiagnostic platform to address the market demands.”
About Zalgen Labs
Zalgen Labs is a biotechnology and diagnostics company with headquarters in Germantown, Md., and an advanced diagnostic product development center in Aurora, Colo. The company specializes in the design and production of superior biological molecules critical for the development and commercialization of immunotherapeutics and novel vaccines as well as reliable, rapid, and affordable diagnostic platforms targeting neglected and underrepresented human infectious diseases. For more information, visit www.zalgenlabs.com.
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 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 has the potential to decrease the waiting period to determine test results by days. The company’s Springdale, Ark., facility was officially registered with the U.S. Food and Drug Administration in December 2014. The company is currently offering an hCG (pregnancy) test in the United States and Europe as well as three 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. For more information about NOWDiagnostics, visit www.nowdx.com.
About the Viral Hemorrhagic Fever Consortium
The Viral Hemorrhagic Fever Consortium was established in 2010 as a result of several multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support Tulane’s ongoing efforts to treat and prevent Lassa fever. For more information, visit www.vhfc.org.