UK-based IDS (Immunodiagnosticsystems) has announced that it has received Food and Drug Administration (FDA) clearance for its 1,25-Dihydroxy Vitamin D assay for use on the IDS-iSYS system. The 1,25-Dihydroxy Vitamin D test is used to measure 1,25-Dihydroxy vitamin D deficiency, which is associated with renal disease and is also used in the diagnosis of disorders in the metabolism of 25 hydroxyvitamin D and phosphate.
The IDS-iSYS 1,25-Dihydroxy Vitamin D kit is a complete test system with the proven immunocapsule extraction and automated chemiluminescence immunoassay. This enables the quantitative determination of 1,25-Dihydroxy vitamin D in human serum and plasma in one working day. IDS launched the assay in Europe in April 2012, and the FDA approval now allows the company to market the assay in the United States. It is estimated that 1,25-Dihyroxy Vitamin D tests represent 15% of the total annual vitamin D testing market.
Patrik Dahlen, CEO of IDS, says, “We are delighted to receive FDA clearance for our automated 1,25-Dihydroxy Vitamin D assay. This will allow us to offer our American laboratory customers the significant efficiency benefits from using this automated assay compared to more traditional testing methods.” Read more about the assay, including a description, a list of features, and assay details.