Diazyme Laboratories, Inc. Receives FDA EUA for COVID-19 Antibody Test














Email


Print Friendly

Share

July 08, 2020 20:32 ET

| Source: General Atomics

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.

More articles issued by General Atomics
More articles related to:
Health
Product / Services Announcement

Spread the word

Discuss

This site uses Akismet to reduce spam. Learn how your comment data is processed.