Aytu Bioscience Inc (NASDAQ:AYTU) recently announced that the U.S Food and Drug Administration (FDA) published the findings from the evaluation of its COVID-19 IgG/IgM rapid test kit by the National Cancer Institute.
The company which develops novel medical products for commercial use developed a rapid test kit for testing coronavirus in people. The test kit, which is dubbed the COVID-19 IgG/IgM rapid test kit, was submitted for testing at the Frederick National Laboratory, which is operated by the National Cancer Institute. The results of the test kit evaluation are finally out and have been published by the FDA.
“This independently-conducted study by the National Cancer Institute further establishes the clinical validity of this rapid test in identifying patients with an adaptive immune response to SARS-CoV-2,” stated Aytu BioScience CEO Josh Disbrow.
The CEO also noted that the COVID-19 IgG/IgM rapid test kit is one of four lateral flow coronavirus test kits that have been greenlit by the FDA for emergency use in the U.S. Disbrow also added that it is important for clinicians to understand how independently evaluated assays function before they determine which one is ideal for clinical use.
The COVID-19 IgG/IgM Rapid Test Kit is ideal for identifying infected patients in the early stages
The COVID-19 IgG/IgM Rapid Test Kit is designed to test the presence of the coronavirus in subjects through IgM and IgG antibody differentiation in the blood, serum, and plasma. The test kit is particularly suited for testing individuals that demonstrate adaptive immunity against SARS-CoV-2. This may help to identify infected individuals even in the early stages of infection. This is great because patients that have been detected in the early stages of infection have a higher chance of surviving. Treatment can be administered as soon as possible, thus preventing the disease’s advancement to chronic stages.
The FDA gave emergency use approval for the use of the COVID-19 IgG/IgM Rapid Test kit on May 29. The approval was granted to Healgen Scientific, LLC, which is a subsidiary of Healgen Scientific, LLC. Aytu Biosciences already signed a distribution agreement Zhejiang Orient Gene on March 10 to facilitate the distribution of the test kit once it receives regulatory approval.