FDA Approves the New 25-Hydroxy Vitamin D Enzyme Immunoassay to be Marketed by Diazyme

Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its new 25-Hydroxy Vitamin D assay. In line with current clinical needs, Diazyme’s new 25-Hydroxy Vitamin D Assay measures total true 25-Hydroxy Vitamin D levels (D2 + D3 levels) in both serum and plasma samples. Furthermore, the assay fully automates the removal of non-specific protein binding and cross reactivity that may occur in competing assays, thereby assuring results will be both precise and accurate.

The 25-Hydroxy Vitamin D assay is both fast and flexible with complete testing results in under 2 hours, making it one of the fastest and most efficient in the marketplace. 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.

Traditionally, testing of Vitamin D levels has been predominantly used for the diagnosis and management of patients with Vitamin D deficiency. Recent clinical studies though have linked Vitamin D deficiency to various diseases including cancers, cardiovascular disease, diabetes, osteoporosis, multiple sclerosis, Alzheimer’s disease and all-cause mortality. This new understanding of importance of Vitamin D levels has driven an increase in the number of physician requests for total 25-Hydroxy Vitamin D tests in the United States and worldwide.

“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. “The assay measures the total Vitamin D, and the results are traceable to the National Institute of Standards and Technology (NIST) standard for vitamin D. The assay takes a much shorter time and can be fully automated when it is run on ELISA instruments such as the Dynex DS2® and DSX® platforms. This unique set of features makes the Diazyme 25-Hydroxy Vitamin D assay a valuable diagnostic test for assessing this important analyte.”