IDH.L Regulatory News (IDH)

2 Jul 2009 07:00



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 newly-developed fully-automated immunoassay for PINP, used as a bone formation marker, to appear on the IDS-iSYS Immunoanalyser.

IDS's new fully-automated Immunoanalyser, the IDS-iSYS, was launched at the end of February, at the same time as the launch of its automated IDS iSYS Vitamin D assay; flagship product 25 Hydroxy Vitamin D, a test to quantify vitamin D in patient serum or plasma.  It is IDS's stated aim that throughout 2009 and into 2010/11, it will add highly complementary bone and skeletal products available for use on IDS-iSYS, such as Parathyroid Hormone (PTH), CTX-I, N-Mid Osteocalcin, PINP, Bone-Specific Alkaline Phosphatase (BSAP), TRAP 5B.

PINP is the second of a number of new products due to appear on the IDS-iSYS by the end of the Financial Year 2009/2010. 

About PINP (Procollagen type 1 N-terminal Propeptide)

The synthesis of type 1 collagen is a crucial step in bone formation and is the major organic component of bone matrix. PINP is cleaved during collagen synthesis and enters the circulation, and its quantification in human serum or plasma therefore provides a valuable measurement of bone formation.

PINP has found a place in routine clinical use as a bone formation marker, and is of particular value in monitoring the efficacy of expensive bone therapies such as the parathyroid hormone (PTH) analogues such as Forteo® (in the USA) or Forsteo® (in the EU) from Eli Lilly. Such analogues are used in the treatment of osteoporosis, and can promote the growth of new bone in post--menopausal osteoporotic women. Osteoporosis affects an estimated 44 million in the USA alone, where osteoporosis-related fractures cost an estimated $19 billion in 2005 (Source: National Osteoporosis Foundation; www.nof.org) .

IDS has obtained a licence from the patent-holders, Orion Diagnostica Oy, Espoo, Finland, who were the first (in 1995) to launch a commercial PINP assay onto the In Vitro Diagnostics (IVD) market. The major benefit of the technology licensed is the ability to determine only intact PINP in patient serum. In certain patient groups, such as those with chronic renal failure, fragments of PINP accumulate in the serum and can give rise to extremely high results if a less specific assay is employed, and this can confuse clinical interpretation.  We believe the only other automated PINP method on the market suffers from this flawed approach.

Dr Roger Duggan, Managing Director of IDS, said:

"The PINP product launched today fits exactly with our philosophy of providing analytical excellence. It is difficult to justify the use of clinical tools that may deliver questionable results when highly specific alternatives are within reach, and our delivery of a fully-automated intact PINP assay will be particularly welcomed by those working with patients with compromised renal function. This is a welcome addition to the evolving range of products to appear on the IDS-iSYS, and we look forward to considerable success in the marketplace."

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