Qualigen Releases FastPack® SARS-CoV-2 Antibody Diagnostic Test

Qualigen Therapeutics has released a pre-launch supply of its proposed FastPack® SARS-CoV-2 IgG Immunoassay diagnostic test kits to the University of Louisville to conduct validation studies with hundreds of patient samples, as well as for use in research on COVID-19. SARS-CoV-2 is the virus that causes COVID-19.

Qualigen's SARS-CoV-2 IgG immunoassay, for use with its new FastPack PRO System point-of-care diagnostic instruments, is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of the presence of SARS-CoV-2 IgG antibodies in blood. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system.

"This is an important step in the evolution of SARS-CoV-2 antibody testing, given the high number of inaccurate tests in the marketplace," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Reliable, accurate and rapid testing for the presence of antibodies is critical to understanding who may have been infected with SARS-CoV-2 and who could potentially have an immune response to re-infection."

Kenneth Palmer, PhD, Director of the University of Louisville Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases (CPM), and his research team will be conducting analytical validation studies on the FastPack SARS-CoV-2 IgG Immunoassay to provide Qualigen with validation data to submit to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization. The University of Louisville's CPM is one of only 12 infectious disease biocontainment facilities in the United States and is on the forefront of COVID-19 and infectious disease research.

"The ability to obtain rapid, accurate SARS-CoV-2 antibody data at the point of care for timely assessment of a patient's status is vital to the next phase of this pandemic. We are excited to be working with Qualigen on this important project," said Dr. Palmer.