Diazyme Laboratories, Inc. Receives Second FDA EUA for COVID-19 Antibody Test
SAN DIEGO, CA – (August 17, 2020) Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test. The Diazyme IgM test runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.
"Diazyme continues to serve during the public health emergency with innovative products in COVID-19 serology (antibody) testing. The IgM test is typically used together with the IgG test for a more complete serology profile. The Diazyme DZ-Lite SARS-CoV-2 IgM test is highly sensitive and specific and does not cross-react when tested with an extensive list of interferents, including no cross reactivity to the common HKU1, OC43, NL63, 229E coronavirus strains. Recent independent performance studies* in peer-reviewed journals cite excellent results with Diazyme serology tests", said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic test reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at www.diazyme.com
For Further Information Contact:
Abhijit Datta, Ph.D.
* Suhandynata, Raymond T et al. "Multi-platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19." The Journal of Applied Laboratory Medicine, jfaa139, https://doi.org/10.1093/jalm/jfaa139
*Suhandynata, Raymond T et al. "Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19." The Journal of Applied Laboratory Medicine, jfaa079, https://doi.org/10.1093/jalm/jfaa079
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the presence of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.