FDA Grants Diazyme Clearance to Market a New Biomarker for Early Detection of Kidney Disease

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LA JOLLA, Calif.— Diazyme Laboratories announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Cystatin C POC Test Kit on the SMART Point of Care System. The SMART Point of Care chemistry system offers a wide range of rapid testing capabilities for cardiovascular and stroke risk, diabetes monitoring and now early detection of acute and chronic kidney disease.

The Cystatin C POC Test Kit is the first to employ this emerging biomarker which offers greater sensitivity than standard tests of kidney function in the early detection of acute and chronic kidney disease. There is a growing body of evidence that indicates that some of the negative outcomes of chronic kidney disease can be averted with early diagnosis and treatment. The test can be run from a whole blood sample obtained in a physician's office, hospital or clinic and delivers accurate and reliable results in minutes.

Studies have reported a 40 percent increase in the prevalence of kidney disease in recent years with a corresponding doubling of the incidence of end-stage renal disease (ESRD) and a tripling of Americans on dialysis.

"The prevalence of chronic kidney disease has reached epidemic proportions, now affecting 13.8 to 15.8 percent of the general US population. The expense of chronic kidney disease is staggering, claiming an estimated one-third of Medicare and Medicaid budgets," Dr. Chong Yuan, managing director of Diazyme Laboratories, said. "Diazyme's new whole blood Cystatin C POC Test K is the first point of care system that utilizes this new more sensitive marker of kidney function. The Cystatin C POC Test Kit provides a convenient and cost effective test method for the earlier detection of both acute and chronic kidney disease (CKD) at the point of care which will benefit laboratories, physicians and patients."

Other assays now available for the SMART Point of Care system include Hba1c for monitoring diabetes control as well as high sensitivity CRP, an emerging marker of inflammation which studies suggest is of value stratifying risk of cardiovascular disease and stroke. Also available for the SMART system is Enzymatic Homocysteine, which is an important biomarker for cardiac and stroke risk assessment.

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