Diazyme SARS-CoV-2 Neutralizing Antibody Assay Receives Emergency Use Authorization
SAN DIEGO – 30 January 2023 – Diazyme Laboratories, Inc. received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration on December 6, 2022, for use of the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit. The test is a high throughput, fully automated assay for the qualitative detection of SARS-CoV-2 neutralizing antibodies and can produce results in 35 minutes. The assay is run on the DZ-Lite 3000 Plus, Diazyme’s FDA-cleared automated analyzer.
“This SARS-CoV-2 Neutralizing Antibody test can help clinicians assess the adaptive immune response after infection; this is particularly important in immuno-compromised patient populations”, said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc.
Diazyme Laboratories is a cGMP and ISO 13485 certified medical device manufacturer located in Poway, California. Diazyme uses innovative enzymatic, immunoturbidimetric and chemiluminescenttechnologies to develop diagnostic reagents for high-throughput, fully automated, laboratory analyzers. Diazyme has been participating in the global COVID-19 mitigation efforts through a portfolio of tests that include qualitative and semi-quantitative diagnostic tests for total SARS-COV-2 IgG antibodies and a qualitative test for total SARS-CoV-2 IgM antibodies. Founded in 2000, Diazyme currently employs over 100 employees and has two international branches.
Schaefer EJ, Dulipsingh L, Comite F, Jimison J, Grajower MM, Lebowitz NE, Lang M, Geller AS, Diffenderfer MR, He L, Breton G, Dansinger ML, Saida B, Yuan C. Corona Virus Disease-19 serology, inflammatory markers, hospitalizations, case finding, and aging. PLoS One. 2021 Jun 10;16(6):e0252818.
The Diazyme assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Testing is limited to Clinical Laboratory Improvement Amendments (CLIA) laboratories that meet requirements to perform high or moderate complexity tests. The product should not be used to diagnose or exclude acute SARS-CoV-2 infection.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C00015.
Technical & Regulatory:
Ben Saida, Ph.D.