FOR IMMEDIATE RELEASE
Feb 26, 2008
POWAY, CA - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Cystatin C Assay Kit for the quantitative determination of Cystatin C in serum and plasma samples. Cystatin C is emerging as a biomarker superior to standard tests of kidney function in the early detection of 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 Diazyme method is a liquid stable, two reagent immunoturbidmeteric system which can be applied to most common clinical chemistry instrumentation. Diazyme has developed an extensive listing of instrument parameters and, along with multiple packaging formats, offers the added convenience of instrument specific formats suitable for use in laboratories of all volumes and workflows.
The assay features excellent accuracy and precision and offers an extended reportable range of 0.47 to over 8 mg/L which will reduce the need for re-testing elevated patient samples. The method also demonstrates insignificant bias from interferents commonly found in serum including highly elevated levels of hemoglobin, bilirubin, triglycerides and ascorbic acid.
General Atomics is a San Diego-based innovation firm with a 50-year history of successful solutions for energy, defense and environmental challenges. Diazyme Laboratories, a division of General Atomics, uses its platform technologies to develop low cost and uniform diagnostic products for clinical and research use. Products include diagnostic blood tests for liver disease, cardiac markers, diabetes, renal disease and electrolytes. Diazyme's enzyme technology and related products can be found in its website at www.diazyme.com.
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Posted on Feb 26, 2008