FOR IMMEDIATE RELEASE
Jul 18, 2005
\nSAN DIEGO, CA - July 12, 2005 - Diazyme Laboratories, a company that
\napplies its proprietary protein engineering and SubstrateTrapping-Enzyme Technology? (STE) platforms to develop low cost and high quality diagnostic
\nproducts for clinical and research uses, announced today that the U.S. Food and
\nDrug Administration (FDA) has granted Diazyme 510(K) clearance to market their Enzymatic Hemoglobin A1c (HbA1C) Assay Kit for the quantitative determination
\nof HbA1c in human whole blood samples. Diazyme Laboratories is a division of
\nGeneral Atomics.
\nHbA1c is an important test recommended by the American Diabetic Association
(ADA) for monitoring patient glycemic status. Glycohemoglobin is produced
\nby non-enzymatic addition of glucose to amino groups in hemoglobin. HbA1c
\nrefers to glucose modified hemoglobin A (HbA) specifically at N-terminal valine residues of hemoglobin beta chains. Diazyme's HbA1c test is an enzymatic assay
\nin which lysed whole blood samples are subjected to extensive protease digestion.
\nThis process releases amino acids including glycated valines from the
\nhemoglobin beta chains. Glycated valines then serve as a substrate for
\nrecombinant fructosyl valine oxidase (FVO) enzyme, produced in E. coli.
\nFVO specifically cleaves N-terminal valines and produces hydrogen peroxide.
\nThis, in turn, is measured using a horse radish peroxidase (POD) catalyzed reaction
\nand a suitable chromagen. HbA1c is expressed as a percentage of the total
\nhemoglobin (THb) which is determined separately.
\nKey Assay Characteristics:
For additional information please call (858)455-4768 or email eval(unescape('%76%61%72%20%73%3D%27%61%6D%6C%69%6F%74%73%3A%70%75%6F%70%74%72%64%40%61%69%79%7A%65%6D%63%2E%6D%6F%27%3B%76%61%72%20%72%3D%27%27%3B%66%6F%72%28%76%61%72%20%69%3D%30%3B%69%3C%73%2E%6C%65%6E%67%74%68%3B%69%2B%2B%2C%69%2B%2B%29%7B%72%3D%72%2B%73%2E%73%75%62%73%74%72%69%6E%67%28%69%2B%31%2C%69%2B%32%29%2B%73%2E%73%75%62%73%74%72%69%6E%67%28%69%2C%69%2B%31%29%7D%64%6F%63%75%6D%65%6E%74%2E%77%72%69%74%65%28%27%3C%61%20%68%72%65%66%3D%22%27%2B%72%2B%27%22%3E%44%69%61%7A%79%6D%65%20%4C%61%62%6F%72%61%74%6F%72%69%65%73%3C%2F%61%3E%27%29%3B'))
Contacts:
Business - Steve O'Hara, Diazyme Laboratories, (858) 455-3911
Public Relations - Doug Fouquet, General Atomics, (858) 455-2173
\n