Our partners at Zalgen recently received the exciting news that the FDA has completed the transfer of Emergency Use Authorization for the ReEBOV® Ebola Antigen Rapid Test.
GERMANTOWN, Md.–(EON: Enhanced Online News)–Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, announced today that its ReEBOV® Antigen Rapid Test received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) on November 3, 2016. This marks the successful transfer of FDA EUA from Corgenix Medical to Zalgen.
“This emergency use authorization from the FDA enables Zalgen and our distribution partners to continue providing this remarkable product worldwide to test suspected Ebola cases”
The test is to be used for the presumptive detection of Ebola viruses (detected in the 2014 – 2016 West Africa outbreak) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). The authorized ReEBOV Antigen Rapid Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test.
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., specializing in the design and production of superior biological molecules critical for the development and commercialization of immunotherapeutics, novel vaccines, and reliable, rapid, and affordable diagnostic platforms targeting neglected and underrepresented human infectious diseases. For more information, visit www.zalgenlabs.com.
About NOW Diagnostics, 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 has the potential to decrease by days the waiting period to determine test results. The company’s Springdale, Ark., facility was officially registered with the U.S. Food and Drug Administration in December 2014. 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