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.

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Thursday, July 9, 2020
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Medical specialties, Medicine, Branches of biology, Blood tests, Immunologic tests, Epidemiology, Immunology, Emergency Use Authorization, Food and Drug Administration, Severe acute respiratory syndrome-related coronavirus, Serology, Clinical Laboratory Improvement Amendments
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San Diego, Us
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GENERAL ATOMICS
Summary
Key Points: 
  • 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.


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.
[email protected]

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Emile Dergham
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*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.

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