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

SAN DIEGO, CA – (July 8, 2020)

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.

  • 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 IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
  • 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.