IDH.L Regulatory News (IDH)

24 Sep 2009 10:06



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 human Growth Hormone (hGH), the third new product to appear on the IDS-iSYS Immunoanalyser since its launch in February 2009.

Growth hormone is the major factor involved in the regulation of growth, and its measurement is essential in identifying the cause of numerous important growth disorders. The global market for hGH immunoassay is estimated to be ca €8.0 million.

The IDS-iSYS offers hGH in addition to its flagship 25-Hydroxy Vitamin D assay, which was joined in July 2009 by Intact PINP, a clinically established and widely accepted bone formation marker.

As new product development accelerates in the remainder of 2009 and through 2010/11, IDS will add additional complementary bone and growth products for use on IDS-iSYS. These will include Parathyroid Hormone (PTH), CTX-I, N-Mid® Osteocalcin, IGF-I, IGFBP-3, Bone Specific Alkaline Phosphatase, and Bone TRAP5b.

The newly launched hGH assay is the first in a series of new analytes to be developed in collaboration with Dr Martin Bidlingmaier of the University of Munich, an eminent opinion leader in the field of analytical aspects of growth hormone-related disorders. The assay has several advantages over existing products, including specificity for only one molecular form of hGH and lack of interference from binding proteins, therefore allowing a more accurate and consistent clinical result. The assay also has zero cross-reactivity with therapeutic recombinant hGH analogues such as Pegvisomant from Pfizer (Somavert®), allowing clinicians to monitor a patients true response to therapy by measuring only 'native' hGH. These features provide a clear market advantage for this ground-breaking IDS product.

Dr Roger Duggan, CEO of IDS, said: 

"It is particularly pleasing to launch the first product from our collaborative programme of product development with Dr Bidlingmaier. His global standing in the field of growth hormone and growth-related biomarkers is such that the analytical and clinical credentials of our products originating from the Medizinische Klinik of München will be beyond question by professionals in the marketplace. It is a further example of IDS 'raising the bar' in quality terms that our competitors must strive to match. The IDS-iSYS hGH assay represents a true advance in growth hormone determination, and whilst this is a modest-size market, we anticipate taking a substantial share from existing competitors. Also, as there is no FDA regulatory requirement for hGH in the USA, the product will co-launch with the IDS-iSYS in the largest global IVD market later in the year."

Enquiries:

About Human Growth Hormone (hGH)

Growth Hormone is secreted from the pituitary gland at the base of the brain. hGH plays an essential role in skeletal and organ growth and is particularly important in childhood.

Deficiency of hGH in childhood results in retarded growth (dwarfism), which becomes apparent at an early age. Diagnosis is confirmed by demonstrating a low level of serum hGH which does not respond to a variety of clinical stimulation tests. hGH deficiency as a result of pituitary insufficiency is the major cause of severe short stature and accurate determination is essential for early diagnosis and therapy1. Recombinant hGH analogues such as Somavert® from Pfizer are now readily available for therapeutic intervention, and the ability to monitor the efficacy of such expensive hGH replacement is highly desirable. Existing methods of hGH determination are unable to differentiate between 'native' hGH and the recombinant forms used in therapy, limiting their usefulness in monitoring treatment. The appearance of a sensitive and specific IDS-iSYS hGH immunoassay, which recognises 'native' hGH but not the recombinant form, represents a major advantage over existing products in the marketplace, and it will therefore address both routine clinical diagnosis of growth disorders and the monitoring of therapy. The European Market for recombinant GH therapy is estimated at almost $900 million in 20092. Excess hGH secretion in childhood is leads to excessive growth of the long bones of the body resulting in gigantism. Heights of 2.4 metres (8 feet) may be achieved. Continued hypersecretion in adults causes acromegaly, a condition characterised by continued growth of the jaw and appendages and progressive thickening of bone and soft tissue.

In each case, diagnosis is confirmed by a raised serum hGH level which does not fall in response to the administration of glucose3. 

References:

1. Cohen P, Rogol AD, Deal CL, Saenger P, Reiter EO, Ross JL, Chernausek SD, Savage MO, Wit JM; 2007 ISS Consensus Workshop participants. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008 Nov;93(11):4210-7.

2. Frost and Sullivan; European Human Growth Hormone Market. 2008 Jul;#H048-52.

3. Growth Hormone Research Society; Pituitary Society. Biochemical assessment and long-term monitoring in patients with acromegaly: statement from a joint consensus conference of the Growth Hormone Research Society and the Pituitary Society. J Clin Endocrinol Metab. 2004 Jul;89(7):3099-102.