Diazyme Laboratories

Diazyme Laboratories, an affiliate of General Atomics, is located in Poway, California and is a cGMP and ISO 13485 certified medical device manufacturer.

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
1. enzyme/enzyme cycling technology for assays in the range of µmole/L sensitivity
2. latex enhanced immunoassay technology for assays in the range of nmole/L sensitivity
3.Diazyme's FemtoQuant^TM technology for assays in the range of pmole/L sensitivity.
The establishment of the FemtoQuant^TM 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^TM (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^TM 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

DIABETES BIOMARKERS

UNIQUE MARKERS FOR IMPROVED DIABETES MONITORING AND DIAGNOSIS
The Missing Piece in Diabetes Testing

GLYCATED SERUM PROTEIN (GSP) (GLYCATED ALBUMIN)
• Rapid evaluation of effectiveness of diet, activity or medication adjustments
• A reliable short-term marker of glycemic control Diazyme's GSP (glycated albumin) test serves as a 2-3 week indicator of average blood glucose
• Diazyme's GSP (glycated albumin) assay eliminates the inaccuracies of conventional fructosamine methods by utilizing a uniquely specific enzymatic method
• Can be used with confidence in patients with conditions that interfere with the RBC lifespan which may reduce the reliability of HbA1c measurements

GSP or GA test used in literatures for
• Gestational diabetes (diabetic pregnancy)
• Hemolytic anemia or blood loss
• Hemodialysis or peritoneal dialysis
• Glycation gap determination
• Rapid evaluation of effectiveness of diet or medication adjustments
• Complementary to HbA1c in diagnosis and screening of diabetes. It offers more conclusive and accurate results when both tests are used

Product Features
Diazyme's enzymatic assay for glycated serum protein provides improved specificity and reliability compared to conventional NBT-based methods. The assay is highly precise with a total CV ≤ 1.3%. The assay offers extensive linearity up to 1354 μmol/L. The assay has no significant interference from: ascorbic acid (5 mg /dL); bilirubin (7.5 mg/dL); bilirubin conjugated (5 mg/dL); glucose (2400 mg/dL; hemoglobin (200 mg/dL); triglycerides (2000 mg/dL); and uric acid (35 mg/dL).

Assay Principle
Diazyme's Glycated Serum Protein Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosaminase^TM, a microorganism originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield PF or amino acids, glucosone and H₂O₂. The H₂O₂ released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546-600 nm is proportional to the concentration of glycated serum proteins.

Research about GSP
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