31 Mar 2010 07:00
Immunodiagnostic Systems Holdings plc
New specialist assays launched for IDS-iSYS
Immunodiagnostic Systems Holdings plc ("IDS"), a leading producer of diagnostic testing kits for the clinical and research markets, announces the launch of three newly-developed fully-automated immunoassays for use on the IDS-iSYS Immunoanalyser:
·; Parathyroid hormone ("PTH") calcium biomarker
·; Insulin-like Growth Factor 1 (IGF-1)
·; Osteocalcin bone protein
These launches bring the IDS-iSYS product range to a total of six specialist immunoassays in line with management expectations. IDS will provide a trading update for the year ending 31 March 2010 on Monday 12 April 2010.
The launch of the IDS-iSYS product for the determination of PTH represents a major market opportunity for IDS. Together PTH and vitamin D regulate calcium in the body. Because of this, physicians frequently request both PTH and 25-Hydroxy Vitamin D tests on the same patient sample to give a better understanding of the underlying conditions. The ability to offer both analytes on the iSYS for simultaneous analysis not only facilitates IDS's entry into the PTH market, but also enhances the attraction of adopting IDS's 25-Hydroxy Vitamin D to prospective customers. PTH is a well-established clinical biomarker almost invariably performed on automated systems, and recent research commissioned by IDS indicates a global market size slightly in excess of €100 million*.
Insulin-like Growth Factor 1 (IGF-1) is produced in the body in response to Growth Hormone (hGH) and is a major factor involved in the regulation of growth. Measuring IGF-1 is essential in identifying the cause of growth disorders such as restricted growth in children, and acromegaly (or 'gigantism') in adults. The IDS-iSYS IGF-1 assay launched today follows hGH as the second product to be developed in close collaboration with Dr Martin Bidlingmaier of the Medizinische Klinik of Munich, an accepted expert in the field of growth hormone and growth-related biomarkers. IGF-1 and hGH are commonly measured together in the clinical situation, so once again, the ability to offer both tests simultaneously on the iSYS will significantly enhance the product offering. The US and European markets for IGF-1 immunoassay alone are estimated to be c. €10.5 million*.
Osteocalcin is the major non-collagenous protein of bone and is an accurate biomarker of bone formation. Its measurement provides valuable information about the rate of bone growth or the efficacy of therapy aimed at building bone or reducing bone loss. The IDS-iSYS N-Mid® Osteocalcin assay measures a very stable form of osteocalcin. IDS estimate that the European market for osteocalcin is worth c. €3.0 million*.
These launches bring the IDS-iSYS product range to a total of six specialist immunoassays and are important contributions to the building of comprehensive 'Diagnostic Panels'. The automated Bone & Skeletal panel of 25-Hydroxy Vitamin D, PTH, PINP and N- Mid® Osteocalcin meets the prime needs of the bone physician, to be joined by CTX-I and Bone-Specific Alkaline Phosphatase in mid-2010. hGH and IGF-1 form the core of the Growth Panel, to be joined by IGFBP-3 in the near future.
New product development will continue throughout 2010 and 2011, and will add still more complementary IDS-iSYS products from a robust R&D pipeline. These are expected to include Bioactive PTH, CTX-II, IGFBP-3 and Bone TRAP5b.
Dr Roger Duggan, CEO of IDS, said:
"These are very important products joining the iSYS range. 'Menu' is a major issue in a laboratory manager's decision to take on any instrument. Whilst the extraordinary growth in Vitamin D testing mandated automation in many labs, and permitted us to launch with a single product, these latest launches, on time and on budget, add enormous strength to our offering. Added to which, I believe that the clinical complementarity of 25-Hydroxy Vitamin D and PTH, and of hGH and IGF-1, will facilitate instrument placements in what are very substantial biomarker markets."
* Bespoke market research for IDS by Enterprise Analysis Corporation of Stamford, CT, USA
Enquiries:
| Immunodiagnostic Systems Holdings Plc | Tel: 0191 519 0660 |
| Roger Duggan, CEO |
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| Paul Hailes, Finance Director |
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| Brewin Dolphin Investment Banking | Tel: 0845 059 6740 |
| Richard Jones |
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| Andrew Emmott |
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| Walbrook PR Ltd | Tel: 020 7933 8787 |
| Paul McManus | Mob: 07980 541 893 |
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| paul.mcmanus@walbrookpr.com |
About IDS
Immunodiagnostic Systems Holdings plc is dedicated to the development and provision of innovative immunoassays for use in clinical and research laboratories worldwide. The Company is focused on creating and sustaining its position as a leading specialist in in-vitro diagnostics, building an enviable capability in de novo product design, development, manufacture and marketing.
IDS designs, manufactures and sells immunoassay kits which are 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. In 2007 the immunoassay sector of the IVD market was estimated to be worth US$ 10bn.