Qualigen Therapeutics, Inc. announced it has begun commercial shipments of its FastPack® SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. This test has been submitted to the U.S. FDA for Emergency Use Authorization (EUA), and earlier this month the Company submitted an official notification to the FDA of its plans to exercise its right to commence sales while the EUA is pending.
The FastPack COVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19, indicating recent or prior infection of the disease. Prior infection is presumed to be indicative of immunity against re-infection for at least some period of time.
The COVID-19 antibody test is designed for use with Qualigen’s new FastPack PRO System, a point-of-care diagnostic instrument. The FastPack PRO System is an upgraded version of Qualigen’s flagship FastPack IP rapid immunoassay diagnostic system – in essence, a “lab in a box” that allows test results to be delivered with the accuracy of large laboratories but much more rapidly. Unlike tests at reference laboratories, the FastPack tests are conducted in physician offices, clinics and hospitals, and provide results in approximately 10 minutes. The Company announced earlier this month that a portion of the proceeds from its recent funding will be used to increase production of the FastPack PRO System.
“We are pleased to start shipping our FastPack PRO systems and serology tests for COVID-19 antibodies, and expect to see a ramp-up of production through the end of the year,” stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. “Testing for SARS-CoV-2 IgG antibodies is likely to be critical to fighting this disease for years to come, not only in this early stage of tracking and tracing, but also in time to prioritize vaccine deployment. We believe our rapid diagnostics offering provides accurate results for clinicians to have more timely and actionable information than other testing approaches can provide.”
Qualigen has been producing high-quality diagnostic testing products for nearly 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people’s lives.
About the FastPack System
The FastPack System is a rapid and highly accurate immunoassay diagnostic testing system consisting of a FastPack analyzer and a FastPack test pouch (a single-use, disposable foil packet that includes the FastPack reagent chemistry). Installed in physician offices, clinics and small hospitals around the world, the system quickly detects diseases and medical conditions at the point-of-care. Since the conception of the system, the Company has expanded its assay menu to 10 tests including tests for prostate cancer, thyroid function, metabolic disorders, antibodies against SARS-CoV-2 and research applications. Over the past 20 years, FastPack has generated more than $100 million in commercial sales. Qualigen’s worldwide distributor for FastPack is Sekisui Diagnostics, LLC, a subsidiary of a multibillion-dollar Japanese chemical and technology company; Sekisui, in turn, works with national distributors including McKesson Corporation and Henry Schein Inc.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The Company’s cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating viral-based infectious diseases, including COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes’ proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS™ is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. The FastPack System menu includes point-of-care diagnostic tests for cancer, men’s health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen’s facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC.