Diazyme Laboratories, Inc. Announces CE-IVD for its Semi-Quantitative SARS-CoV-2 Neutralizing Antibody Test

SAN DIEGO, CA – (March 30, 2021)

Diazyme Laboratories, Inc. announced today that it has obtained CE-IVD marking for its SARS-CoV-2 neutralizing antibody test. The Diazyme test is a high throughput chemiluminescent immunoassay with excellent correlation to a fluorescence based neutralization assay, which has been used to evaluate the adaptive immune response in vaccine studies1.  Diazyme also announced plans to work with US FDA for EUA application.

“Unlike the widely available total SARS-CoV-2 IgG antibody tests, Diazyme’s neutralizing antibody test measures the subset of neutralizing antibodies that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein and the human ACE2 cell surface receptor. The Diazyme neutralizing antibody test gives the scientific community and health authorities a valuable tool to evaluate the level of effective antibodies generated after infection or vaccination, and to assess adaptive immunity in studies going forward. Diazyme serology tests meet real world expectations from healthcare professionals and have been independently evaluated in several published studies2-4,” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc.

About Diazyme

Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, is located in Poway, California, USA. 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:

Sales
Emile Dergham
sales@diazyme.com

Regulatory/Operational
Abhijit Datta, Ph.D.
support@diazyme.com

References

  1. E E. Walsh, M.D., R W. Frenck, Jr., M.D., A R. Falsey, M.D., et al., Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates, New England Journal of Medicine, 2020; 383:2439-2450, https://www.nejm.org/doi/full/10.1056/NEJMoa2027906
  2. R T. Suhandynata, M A. Hoffman, M J. Kelner, et al., Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19, The Journal of Applied Laboratory Medicine, Volume 5, Issue 5, September 2020, Pages 908–920, https://doi.org/10.1093/jalm/jfaa079
  3. R T. Suhandynata, M A. Hoffman, M J. Kelner, et al., Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19, The Journal of Applied Laboratory Medicine, Volume 5, Issue 6, November 2020, Pages 1324–1336, https://doi.org/10.1093/jalm/jfaa139
  4. R T. Suhandynata, N J. Bevins, J T. Tran, et al., SARS-CoV-2 Serology Status Detected by Commercialized Platforms Distinguishes Previous Infection and Vaccination Adaptive Immune Responses, medRxiv, 2021.03.10.21253299; doi: https://doi.org/10.1101/2021.03.10.21253299