Qualigen to sell SARS-CoV-2 test in U.S. in July

Jun 30, 2020

Qualigen Therapeutics notified the U.S. Food and Drug Administration (FDA) that it will begin selling its SARS-CoV-2 antibody test in the U.S. this month.

The notification allows Qualigen to sell its FastPack SARS-CoV-2 immunoglobulin G (IgG) test while the FDA considers granting its request for an emergency use authorization for the product. The company expects sales and shipments of the test to start in mid-July.

The test is a chemiluminescent microparticle test intended for the qualitative detection of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19. Results are delivered in fewer than 10 minutes, according to Qualigen.

Qualigen to sell SARS-CoV-2 test in U.S. in July

FDA issues EUAs for 2 POC COVID-19 tests

FDA awards EUA to Alphadera Labs’ COVID-19 test

FDA authorizes Discover Labs to run molecular COVID-19 test at its Texas facility

Cue Health receives FDA emergency use authorization for molecular mpox test

FDA issues EUAs for 2 POC COVID-19 tests

FDA awards EUA to Alphadera Labs’ COVID-19 test

FDA authorizes Discover Labs to run molecular COVID-19 test at its Texas facility

Cue Health receives FDA emergency use authorization for molecular mpox test

Mologic receives FDA EUA for at-home SARS-CoV-2 antigen test, eyes additional respiratory diseases

Lucira Health files for bankruptcy despite receiving FDA green light

FDA authorizes Lucira Health OTC test, the first to detect influenza and COVID-19 viruses

FDA grants emergency use authorization for Anavasi LAMP-based COVID-19 test, detector

FDA authorizes Cepheid molecular test to detect monkeypox virus at the point of care

BD nabs FDA authorization for SARS-CoV-2, influenza A/B, RSV combination test

LumiraDx obtains FDA authorization for test to detect flu A, flu B, SARS-CoV-2

Lucira Health applies for FDA Emergency Use Authorization of over-the-counter COVID-19, flu A, flu B molecular test