Diazyme Laboratories, Inc. Receives FDA EUA for COVID-19 Antibody Test
SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Diazyme announces
receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme
DZ-Lite SARS-CoV-2 IgG CLIA test. The Diazyme IgG test is run on the fully
automated DZ-Lite 3000 Plus chemiluminescence analyzer.
“Diazyme has been at the forefront of the development effort to bring timely, high quality COVID-19 serology (antibody) tests during the public health emergency. The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology tests. The Diazyme DZ-Lite SARS-CoV-2 IgG test does not cross-react when tested with an extensive cross-reactivity profile list, including no cross reactivity to the common HKU1, OC43, NL63, 229E coronavirus strains. The assay uses both S and N proteins of SARS-CoV-2 virus to detect SARS-CoV-2 IgG. We are pleased that the Diazyme serology tests currently deployed meet real world expectations from healthcare professionals. We value scientists who have independently performed studies and have published peer-reviewed data*", said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
About Diazyme
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:
Regulatory/Operational
Abhijit
Datta, Ph.D.
support@diazyme.com
Sales
Emile Dergham
sales@diazyme.com
*The Journal of Applied Laboratory Medicine, jfaa079, https://doi.org/10.1093/jalm/jfaa079
Required
Notice:
For Prescription Use only. For in vitro Diagnostic
use only. For Emergency Use Authorization only.
