Diazyme Receives NGSP Certification of Traceability for the Enzymatic HbA1c Assay Product

FOR IMMEDIATE RELEASE

Mar 22, 2006

SAN DIEGO, CA - March 1, 2006 - Diazyme Laboratories announced today that it has successfully completed the National Glycohemoglobin Standardization Program (NGSP; www.ngsp.org) manufacturer certification for its Enzymatic Hemoglobin A1c (HbA1C) Assay Kit. The Diazyme HbA1c method is now considered to be traceable to the Diabetes Control and Complications Trial (DCCT) reference method. Diazyme's HbA1c assay is used for the quantitative determination of HbA1c in human whole blood samples without the need for blood cell separation.

HbA1c is an important test recommended by the American Diabetic Association (ADA) for monitoring patient glycemic status. Glycohemoglobin is produced by non-enzymatic addition of glucose to amino groups in hemoglobin. HbA1c refers to glucose modified hemoglobin A (HbA) specifically at N-terminal valine residues of hemoglobin beta chains. Diazyme's HbA1c test is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as a substrate for recombinant fructosyl valine oxidase (FVO) enzyme. FVO specifically cleaves N-terminal valines and produces hydrogen peroxide which is detected. HbA1c is expressed as a percentage of the total hemoglobin (THb).

Key Assay Characteristics:

• Whole blood specimens are used in the assay. No extra steps needed to separate RBCs.
• All liquid stable reagents. Easy to use on automated chemistry analyzers.
• No latex or bead based components. Reagents do not coat cuvettes or clog analyzer lines.
• Excellent performance characteristics with CV% of < 3%
• Excellent correlation to HPLC method
• No interferences from acetylated, carbamylated or labile HbA1c.
• Variant Hemoglobin S and C do not affect results.