New specialist assay launched for IDS-iSYS

Immunodiagnostic Systems Holdings plc

New specialist assay 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 a fully-automated immunoassay for serum or plasma CTX-I for use on the IDS-iSYS Immunoanalyser.

CTX-I, otherwise known as CrossLaps®, is an acronym for the degradation product of Type I collagen, which is the major form of collagen found in bone. Determination of CTX-I is helpful in the management of osteoporosis and particularly in the monitoring of anti-resorptive therapy. It may also have a role in the prediction of fracture risk in post-menopausal osteoporotic women.

Determination of CTX-I is patent protected, and became part of IDS' Intellectual Property portfolio with the acquisition of Nordic Bioscience Diagnostics, the original inventors, in 2007. Rights were granted to one other licensee ahead of this acquisition.

The launch of CTX-I on the IDS-iSYS is an important addition to the Bone Panel of analytes. It now joins 25-Hydroxy Vitamin D, Parathyroid Hormone (PTH), Intact PINP and N-Mid Osteocalcin on the fully-automated IDS-iSYS. This provides the bone physician with the wherewithal, at the press of a button, to simultaneously determine calciotrophic hormones (vitamin D and PTH, controlling the absorption, retention and use of calcium) along with biomarkers of bone formation (PINP and Osteocalcin) and bone resorption (CTX-I) in the same serum or plasma sample.

No other IVD company offers this comprehensive range of bone biomarkers on a single platform.

The European market size for CTX-I is estimated to be Euro 4.3 million*.

This launch brings the IDS-iSYS product range to a total of seven specialist immunoassays. IDS is approaching other disease-related 'panels' of analytes to offer the same analytical convenience in the provision of a Growth Panel (human Growth Hormone and IGF-I are already launched), a Cartilage Panel and a Hypertension Panel.

Dr Roger Duggan, CEO of IDS, said:

"The IDS-iSYS analyte range is expanding very satisfactorily. A core area of interest at IDS is bone & calcium disease, and CTX-I is an important analyte providing a sensitive biomarker of bone resorption. New product development will continue throughout 2010 and 2011, and will add still more complementary automated products from a robust R&D pipeline. These will include Bioactive PTH, CTX-II, Bone Specific Alkaline Phosphatase, IGFBP-3 and Bone TRAP5b and will put the IDS-iSYS in a league of its own."

* Bespoke market research for IDS by Enterprise Analysis Corporation of Stamford, CT, USA

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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.