Fourth FDA Emergency Use Authorization of a COVID-19 IgG/IgM Lateral Flow Rapid Test
1.4 Million Rapid Tests Available for Distribution at Company's Warehouse
ENGLEWOOD, CO / ACCESSWIRE / June 1, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant medical needs, today announced the U.S. Food and Drug Administration (the "FDA") has granted Emergency Use Authorization (EUA) for the COVID-19 IgG/IgM Rapid Test Cassette distributed by the Company. This is only the fourth lateral flow COVID-19 rapid serology test authorized by the FDA.
Additionally, more than 1.4 million COVID-19 IgG/IgM rapid tests have been delivered to the Company's warehouse in San Diego and are available for distribution.
Emergency Use Authorization of the COVID-19 IgG/IgM Rapid Test Cassette was granted by the FDA on May 29, 2020 to Healgen Scientific, LLC, the U.S. subsidiary of manufacturer Zhejiang Orient Gene Biotech, Limited. Aytu BioScience announced a U.S. distribution agreement to distribute the Zhejiang Orient Gene rapid test on March 10, 2020.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative test for the detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in whole blood, plasma (Li+-heparin, K2-EDTA and sodium citrate), and serum. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "This Emergency Use Authorization is an important milestone for the Company in its fight against the COVID-19 pandemic. This EUA establishes the clinical utility of the COVID-19 IgG/IgM Rapid Test in helping to identify individuals demonstrating an immune response to the COVID-19 virus. This test may serve as an important clinical tool as the U.S. and other countries work to reopen businesses and schools and we collectively work to re-establish normalcy in our everyday lives. Further, with more than 1.4 million tests now in stock at our San Diego warehouse, we look forward to serving the medical professionals in need of serology testing. We are proud to be playing a role to help in the COVID-19 health crisis."
The FDA authorization letter for the COVID-19 IgG/IgM Rapid Test Cassette can be found in the link below: