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's focus is to utilize three (3) platform technologies to develop highly sensitive liquid stable reagents for use on general clinical chemistry analyzers. The 3 platform technologies include enzyme/enzyme cycling technology for assays in the range of µmole/L sensitivity; latex enhanced immunoassay technology for assays in the range of nmole/L sensitivity; and Diazyme's FemtoQuant™ technology for assays in the range of pmole/L sensitivity. The establishment of the FemtoQuant™ technology allows Diayzme to convert numerous current heterogeneous immunoassays into homogenous enzymatic assays. These homogenous enzymatic assays are run on general clinical chemistry analyzers that are used in clinical laboratories. The 3 platform technologies essentially cover the sensitivities needed for the majority of clinical diagnostic tests including; metabolites, special proteins, drugs, hormones, vitamins and electrolytes.

Platform

Sensitivity

Related Patents

Enzyme/Enzyme cycling technology

µmole/L (10-6M)

U.S. 7,192,729
U.S. 7,855,079

Latex enhanced immunoassay

nmole/L (10-9M)

U.S.13/707,514

FemtoQuant™ (enzyme-immunoassay)

pmole/L (10-12M)

U.S.13/352,273

Diazyme has also developed a novel chemiluminescent immunoassay technology that has sensitivity close to single molecule detection. This Single Molecular Sensitive Chemiluminescent Immunoassay (SMS-CLA) technology utilizes alkaline phosphatase labeled antibody tracers to generate specific molecules serving as substrates for Diazyme's FemtoQuant™ technology that rapidly amplifies chemiluminescent signal for detection. The SMS-CLA technology allows development of assays that require extreme high sensitivity, such as some tumor markers and cardiac markers, and potentially rapid molecular diagnostics (DNA and RNA tests) without the polymerase chain reaction (PCR) step.

Platform

Sensitivity

Related patent

SMS-CLA

<3 aM
or <300 molecules

U.S.13/352,273