IDH.L Regulatory News (IDH)

12 Aug 2005 10:42

Immunodiagnostic Systems Hldgs PLC12 August 2005 For Release 12 August 2005 Immunodiagnostic Systems Holdings PLC ("IDS" or the "Company") 'NEW VITAMIN D TESTING KIT CLEARED BY FDA FOR CLINICAL USE IN THE US' IDS, a leading producer of diagnostic testing kits, announces it has receivedFDA 510(k) clearance from the US FDA for their recently-released 1,25-DihydroxyVitamin D EIA (1,25D) kit . The company won a Queen's Award for Technological Achievement in 1999 for thesuccess of the first generation of radioactive 1,25D product, and this newrelease will expand the market to smaller laboratories and those unable to useor dispose of radioactivity. 510(k) clearance allows the company to provide theimmunoassay kits to the clinical markets in the United States for humandiagnostic purposes, rather than simply for research use. The 1,25-DihydroxyVitamin D EIA kits are used to measure vitamin D within a patients sample, thusaiding the diagnosis or monitoring of a diseases of bone and skeletaldevelopment, or providing information for research studies. Commenting on the approval, Managing Director IDS, Dr Roger Duggan said,' We aredelighted that we have gained FDA approval for this unique product so soon afterrelease. The 1,25-Dihydroxy Vitamin D EIA kit uses our award winning technology,is easy to handle and dispose of as it has no radioactive properties, and doesnot require laboratories to have a radioisotope certificate . He added, 'I would like to thank all the IDS team for their efforts during thedevelopment of this product which, I am sure, will prove to be a great successand a highly valuable part of our portfolio.' Enquiries: IDS Holdings plc Binns & Co PR Ltd Roger Duggan, Managing Director Paul McManusTel: 0191 519 6109 Tel: 020 7153 1485 Mob: 07980 541 893 This information is provided by RNS The company news service from the London Stock Exchange