IDS Gains FDA Clearance for a New Specialist Assay

Immunodiagnostic Systems Holdings plc, a leading producer of diagnostic testing kits and automated systems for the clinical and research markets, has received clearance from the US Food and Drugs Administration (FDA) for its Intact PTH automated immunoassay kit. The Intact PTH assay is intended for the quantitative determination of parathyroid hormone levels in human serum or plasma on the IDS-iSYS automated analyser. Results of the tests are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism, which will enable doctors to more accurately diagnose parathyroid disease and to monitor patients undergoing renal dialysis and other diseases caused by calcium homeostasis. Ian Cookson, CEO of IDS, said: “As part of our strategy to diversify our product offering, we are pleased to have received FDA clearance for this important assay. The ability to offer Intact PTH on the IDS-iSYS in the US complements our automated 25 Hydroxy Vitamin D assay
and will further facilitate the placement of IDS- iSYS systems.”