Diazyme Laboratories, Inc., founded in 2000, applies multiple analytical platform technologies to develop innovative clinical diagnostic reagents which can be used on most automated chemistry or immunoassay analyzers. Diazyme specializes in developing clinical diagnostic tests that are either technically challenging or unique in test design to overcome clinically unmet needs. Diazyme products cover a wide range of disease areas including cardiovascular disease, cancer, liver disease, renal disease, diabetes, sepsis, inflammatory disease, vitamins, and electrolytes.


Diazyme Laboratories is located in Poway, California and is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme has established two oversea branches including Diazyme Europe GmbH a sales organization, and Shanghai Diazyme, a raw material manufacturer producing diagnostic enzymes, monoclonal and polyclonal antibodies.



Chong Yuan, Ph.D. – Managing Director
Dr. Yuan, a leading enzymologist, is the managing director and co-founder of Diazyme Laboratories. He is the inventor of multiple U.S. patents covering Diazyme product technology.


Innovations in Clinical Diagnostics:  Diazyme Laboratories, Inc. uses its proprietary enzymatic assay and immunoassay technologies to develop cost effective and user friendly clinical diagnostic products that better equip physicians to effectively treat their patients. Diazyme has developed proprietary techniques and reagent formulation know-hows for assay developments utilizing the following platform technologies accordingly depending on the nature of specific analytes as shown in the table below.

Analytes Sensitivity Platform
Metabolites µmole/L Enzyme/Enzyme Cycling
Vitamins, Hormones, Drugs ng/mL Small Molecule Sandwich Assay (Latex)
Proteins ng/mL Latex Enhanced Immunoturbidimetric Assay
Low Level Small & Large Molecules pg/mL to fg/mL CLIA or SMS-CLA*

*CLIA:  Chemiluminescent Immunoassay; SMS-CLA; Single Molecule Sensitive Chemiluminescent Assay