FDA Grants Diazyme Laboratories 510(k) Clearance to Market a Biomarker for Early Detection of Kidney Disease

SAN DIEGO, CA--(Marketwire - November 08, 2012) -

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Diazyme Laboratories announced today 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% increase in the prevalence of kidney disease in recent years with a corresponding doubling of the incidence of end-stage renal disease and a tripling of Americans on dialysis. Dr. Chong Yuan, Managing Director of Diazyme Laboratories, said, "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. 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 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.

Diazyme Laboratories is a division of General Atomics headquartered in La Jolla, California. Diazyme uses its enzyme platform technologies to develop low cost and uniform diagnostic products for clinical and research uses. Products include diagnostic blood tests for liver disease, cardiac markers, diabetes, renal disease and electrolytes. Information regarding Diazyme's enzyme technology and related products can be found in its website at www.diazyme.com.