TIDMIDH
RNS Number : 5948Z
Immunodiagnostic Systems Hldgs PLC
24 September 2009
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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 EUR8.0
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:
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| Immunodiagnostic Systems Holdings | Tel: 0191 519 0660 |
| Plc | |
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| Roger Duggan, CEO | |
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| Paul Hailes, Finance Director | |
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| | |
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| Brewin Dolphin Investment Banking | Tel: 0845 213 4730 |
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| Andrew Emmott | |
| Sean Wyndham-Quin | |
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| | |
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| Walbrook PR Ltd | Tel: 020 7933 8787 |
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| Paul McManus | Mob: 07980 541 893 |
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| | paul.mcmanus@walbrookpr.com |
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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.
This information is provided by RNS
The company news service from the London Stock Exchange
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