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Aytu BioScience Announces Results from a National Cancer Institute Evaluation of the Company’s Licensed COVID-19 IgG/IgM Rapid Test
National Cancer Institute's (NCI) analysis of COVID-19 IgG/IgM Rapid Test Cassette Reported 100% Combined Sensitivity, and 97.5% Combined Specificity for the
About this update from Aytu Biopharma, Inc.
[{"type":"text","content":"National Cancer Institute's (NCI) analysis of COVID-19 IgG/IgM Rapid Test Cassette Reported 100% Combined Sensitivity, and 97.5% Combined Specificity for the Lateral Flow ImmunoassayENGLEWOOD, CO / ACCESSWIRE / June 9, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the \"Company\") focused on commercializing novel products that address significant patient needs announced today that the U.S. Food and Drug Administration (the \"FDA\") has published data from the National Cancer Institute's (NCI) Frederick National Laboratory for Cancer Research, and its evaluation of the COVID-19 IgG/IgM Rapid Test distributed by the Company.A well-characterized panel of 30 confirmed SARS-CoV-2 antibody positive, and 80 SARS-CoV-2 antibody-negative samples collected prior to 2020 were tested in an independent validation study performed by the NCI. 96.7% and 100% sensitivity were estimated for IgG and IgM, respectively. 97.5% and 100% specificity were estimated for IgG and IgM, respectively. Furthermore, combined sensitivity and specificity were 100% and 97.5%, respectively.Measure:Estimate:95% Confidence Interval:IgG Sensitivity96.7%(83.3% - 99.4%)IgM Sensitivity100.0%(88.7% - 100%)IgG Specificity97.5%(91.3% - 99.3%)IgM Specificity100.0%(95.4% - 100%)Combined Sensitivity100.0%(88.7% - 100%)Combined Specificity97.5%(91.3% - 99.3%)Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, \"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. As one of only four lateral flow SARS-CoV-2 immunoassays to receive an Emergency Use Authorization from the U.S. FDA, it is important that clinicians understand the performance of the independently validated assays as they select an appropriate test for clinical use.\"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.Emergency Use Authorization of the COVID-19 IgG/IgM Rapid Te...