24th Jun 2013 07:00
24 June 2013
Immunodiagnostic Systems Holdings plc
FDA clearance of automated 1,25-Dihydroxy Vitamin D assay on the IDS-iSYS system
IDS ("IDS" or '"the Company") is pleased to announce that it has received USA FDA (Food and Drug Administration) clearance for its 1,25-Dihyroxy 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 a single working day providing significant efficiency benefits in vitamin D testing for laboratories.
IDS launched the first ever automated assay for 1,25-Dihydroxy vitamin D 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, which is $135M for the US (Source: Kalorama Worldwide (2012); Mkt for IVD Tests 8th Edition).
Patrik Dahlen, CEO of IDS, said:
"We are delighted to receive FDA clearance for our automated 1,25-Dihydroxy Vitamin D assay. This will allow us to market this assay in the United States and offer our laboratory customers the significant efficiency benefits from using this automated assay compared to more traditional testing methods".
For further information:
Immunodiagnostic Systems Holdings plc | Tel : +44 (0)191 5190660 |
Patrik Dahlen, Chief Executive Officer | |
Chris Yates, Finance Director | |
Peel Hunt LLP | Tel : +44 (0)207 418 8900 |
James Steel | |
Dr Vijay Barathan | |
FTI Consulting | Tel : +44 (0)207 831 3113 |
Ben Atwell | |
Simon Conway | |
Mo Noonan |
About Immunodiagnostic Systems Holdings PLC
The Group operates in the in-vitro diagnostics ("IVD") market by designing, manufacturing and selling immunoassay kits as well as its automated analyser, the IDS-iSYS System. The IDS product range is used to measure or detect particular substances within a sample, thus aiding the diagnosis or monitoring of a disease or providing information for research studies.
http://www.idsplc.com
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