POWAY, CA -- 02/25/08 --
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.
For Further Information Contact:
Diazyme Laboratories:
Chong Yuan
(858) 455-4760
Email: chong.yuan@gat.com
Public Relations:
Doug Fouquet
(858) 455-2173
Email: fouquet@ga.com
