Diazyme Receives FDA 510(k) Clearance for Vitamin D Assay


Jan 24, 2011

SAN DIEGO, CA--(Marketwire - January 24, 2011) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its 25-Hydroxy Vitamin D assay. Diazyme's 25-Hydroxy Vitamin D test is an innovative homogenous assay which measures the true total 25-Hydroxy Vitamin D (sum of both D3 + D2). The new assay introduces a number of enhancements including a wide dynamic range with improved precision while eliminating time consuming washing steps and the error caused by "matrix effects" which can lead to inaccurate results with other 25-Hydroxy Vitamin D methods. The assay is both fast and flexible with testing throughput up to five times faster than other competitive products. The test is user-friendly and can be used manually or easily adapted for use on a wide range of fully automated microtiter plate readers, making it suitable for use in laboratories of all sizes and testing needs. The assay can also be adapted to automated chemistry analyzers such as Hitachi 911 after a sample pre-treatment step.

Reports indicate there has been a recent increase in the number of physician requests for total 25-Hydroxy Vitamin D tests in the United States. This increase has been driven by a large number of recent clinical studies on Vitamin D deficiency which is reported to be linked to various diseases including cancers, cardiovascular disease, diabetes, osteoporosis, multiple sclerosis, Alzheimer's disease and all-cause mortality. Testing of Vitamin D levels has become the cornerstone for the diagnosis and management of patients with Vitamin D deficiency. "Diazyme's new 25-Hydroxy Vitamin D assay provides a convenient and cost effective test method for laboratories of virtually all sizes," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "In addition to measuring true total Vitamin D, the Diazyme 25-Hydroxy Vitamin D assay is directly traceable to the newest standard reference materials from the National Institute of Standards and Technology (NIST) for accurate and reliable results. This unique set of features makes the Diazyme 25-Hydroxy Vitamin D assay a valuable new technology for assessing this important analyte."

Diazyme Laboratories is headquartered in Poway, California. Diazyme uses its enzyme platform technologies to develop innovative assays for clinical and research uses with reduced costs and improved performance. Products include diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease and electrolytes. Information regarding Diazyme's enzyme technology and related products can be found on its website at www.diazyme.com.

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Diazyme Laboratories:

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Doug Fouquet

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