Diazyme Receives 510(K) FDA Approval for Homocysteine Assay Kit
SAN DIEGO, CA - Sept. 3, 2003 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology® (STE) to develop low cost and high quality diagnostic products for clinical and research uses, announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market the Homocysteine Microtiter Plate Assay Kit.
Diazyme has developed a Microtiter Plate Assay Kit to determine plasma homocysteine levels based on the STE Technology®. The assay involves no immunochemical reactions and requires less blood sample volume than immuno assays. The assay has now been fully automated with Diazyme's auto-analyzer Accuraâ„¢.
Homocysteine (an amino acid) is becoming a very familiar term in recent days as a cardiovascular disease indicator. More than three decades ago, Kilmer McCully, MD, a Harvard pathologist, published a paper in the American Journal of Pathology noting that elevated blood homocysteine levels may cause coronary heart disease (CHD). In the 1990's, the explosion of studies examining this hypothesis have brought homocysteine and it's role as a risk factor for CHD into a whole new light. Today, it is widely accepted that an elevated level of homocysteine is a risk factor for cardiovascular disease.
Posted on Sep 3, 2003