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 lead 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.”