14 Feb 2012 07:00
14 February 2012
Immunodiagnostic Systems Holdings plc
("IDS" or '"the Company")
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, today announces that clearance has been received from the US Food and Drugs Administration (FDA) for the Company's Intact PTH automated immunoassay kit, enabling this product to be sold in the USA.
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."
For further information:
Immunodiagnostic Systems Holdings plc | Tel: +44 (0)191 519 0660 |
Ian Cookson, Chief Executive Officer Paul Hailes, Finance Director | |
Peel Hunt LLP | Tel: +44 (0) 20 7418 8900 |
James Steel Dr Vijay Barathan | |
FTI Consulting | Tel: +44 (0) 20 7831 3113 |
Ben Atwell Simon Conway Mo Noonan |