Zalgen and the VHFC have successfully developed recombinant protein based rapid diagnostic tests (RDTs) for the point-of-care (POC) detection of viral hemorrhagic diseases including Ebolavirus disease (EVD) and Lassa Fever (LF).
The ReEBOV® Antigen Rapid Test, the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus, is also the first listed for procurement by the World Health Organization (WHO). This test was developed by the VHFC to address diagnostic needs during the 2014 – 2016 EVD outbreak in West Africa.
The ReLASV® Antigen Rapid Test for LF diagnosis, the first RDT for Lassa virus to be CE Marked, and a large line of other products for research use only (RUO), comprise the bulk of our diagnostics development programs and revenue stream.
The ReSARS® CoV-2 ELISA for detection of antibodies against N Nucleocapsid and S Glycoprotein antigens were rapidly developed to address the current COVID-19 pandemic. The US FDA is currently evaluating our first Emergency Use Authorization (EUA) application for the use of SARS CoV-2 Antibody ELISA in clinical diagnostic settings. We are developing additional novel SARS CoV-2 ELISA platforms and rapid antigen diagnostic tests to address additional public health needs in the current COVID-19 pandemic.
We have initiated development of diagnostic platforms for additional viral hemorrhagic fever agents with pandemic potential, namely Crimean Congo Hemorrhagic Fever (CCHF).
The company has developed a library of fully human antibodies against viral infectious diseases to increase the protective efficacy of treatment, while greatly decreasing the virus’ ability to generate escape mutant strains. Arevirumab-3, the first-in-class immunotherapeutic for prophylaxis and post-exposure treatment of Lassa fever (LF) is completing pre-clinical testing in large animal models of the disease. Zalgen plans to submit a pre-IND application with the US FDA for regulatory evaluation of the program and guidance toward first-in-human clinical studies.
Zalgen has an active vaccine discovery program that employs the newly solved LASV glycoprotein trimer molecule stabilized in its pre-fusion structure. Since this form of the viral receptor does not potentiate fusion with host cell membranes other fusogenic viral glycoproteins are incorporated into the vaccine vector that result in a replicative and bivalent vaccine candidate. The biology of stable co-expression of stabilized, pre-fusion LASV and other native viral glycoproteins is being optimized for expression and relevant presentation in a replicative vaccine vector.
To this end the company is currently conducting pre-clinical evaluation of a first-in-class bivalent vaccine for all circulating lineages of Lassa virus and Ebola virus.
The company utilizes proprietary expression platforms, including its patented mammalian cell-based biomanufacturing system, CHOLCelect, to deliver next generation biologicals for world health and biodefense. These critical materials provide the basis for Zalgen products and programs.
Lassa diagnostics training session at the Broad Institute, Cambridge MA. An annual program sponsored by Harvard/Broad and ACEGID. Physicians and scientists from laboratories in Nigeria, Sierra Leone Ghana, Senegal, Liberia, Mali and other African countries travel to Boston for advanced training in viral hemorrhagic fever technology.
Read more about our people and programs to learn how Zalgen is making a difference today in advancing medical countermeasures to address viral hemorrhagic fevers and other diseases.
7495 New Horizon Way, Suite 120
Frederick, MD 21703 USA
Office: (833) 482-8833
International: (301) 720-0330
Fax: (301) 349-1194
12635 E. Montview Blvd, Suite 131
Aurora, CO 80045 USA
Office: (888) 410-2594
International: (301) 720-0330
Fax: (720) 859-4110