Qualigen Therapeutics has submitted an official notification to the US Food and Drug Administration (FDA) to begin the sale of its FastPack SARS-CoV-2 IgG test for Covid-19 antibodies in the US.

The US-based biotech company has already applied with the FDA for Emergency Use Authorisation (EUA), and the notification enables it to start the sales prior to the formal award of EUA for the test from the regulatory agency.

Qualigen expects to start the sale of new tests from mid-July 2020.

Qualigen CEO Michael Poirier said: “Of the different options available, we chose to develop a test specific to the IgG antibody because IgG represents the long-term immune response.

“We believe our test’s combination of high speed and high accuracy provides the clinician with more useful and actionable information than other testing approaches. We believe that reliable, yet convenient testing at the point-of-care is critical to helping combat this virus and get Americans back to their normal routines.”

FastPack uses a specific protein that is used by major diagnostics companies

FastPack Covid-19 antibody test is a chemiluminescent microparticle test designed for qualitative detection of SARS-CoV-2 IgG antibodies in blood, identifying individuals with an adaptive immune response to the virus that causes Covid-19.

The diagnostic test uses a specific protein, which is also being used by major diagnostics companies including Abbott Laboratories, Roche Diagnostics and Bio-Rad Laboratories in their Covid-19 antibody tests, said the company.

The new test has been designed for use with Qualigen’s new FastPack PRO System point-of-care diagnostic instruments. The FastPack PRO System is an upgraded version of Qualigen’s flagship FastPack IP rapid immunoassay diagnostic point-of-care system.

FastPack is a rapid, high accuracy immunoassay testing system that comprise FastPack Analyser and the FastPack test pouch, a single-use, disposable, foil packet that includes the FastPack reagent chemistry.

The ‘Laboratory in a Pouch’ test system can be installed in physician offices, clinics and small hospitals for rapid detection of diseases and medical conditions at the point-of-care.

In addition, the test will provide benefits over testing in large commercial laboratories, through its capability to deliver accurate results more rapidly, within 10 minutes.