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International Guidelines for First-Line use of Freelite(TM) in Diagnosis and Management of Multiple Myeloma to be Published in "Leukemia"

Posted on: Wednesday, 28 January 2009, 03:00 CST

BIRMINGHAM, England, January 28 /PRNewswire/ -- The Binding Site Limited ("The Binding Site" or the "Company"), a privately-owned specialist U.K. diagnostics company, today announces the publication of the first international guidelines recommending first-line use of Freelite(TM) in the diagnosis and management of multiple myeloma, a cancer of cells in the bone marrow, and related plasma cell disorders.

The guidelines were written on behalf of the International Myeloma Working Group ("IMWG"), led by Dr. A Dispenzieri, Division of Hematology and Division of Laboratory Medicine, Mayo Clinic, USA, and will be published in Leukemia, a leading haematology and oncology journal, in February 2009.

Freelite is a unique assay, developed and marketed by The Binding Site, used for the diagnosis and monitoring of multiple myeloma (MM) and related disorders. Immunoglobulin free light chains (FLC) in serum are an important tumour marker present in patients suffering from MM and associated malignancies. The only test available for measuring serum FLC is The Binding Site's Freelite assay. To date, the test has been incorporated into clinical practice on the basis of published evidence. These new international guidelines have been written specifically to guide clinicians in the use of serum FLC measurements in their diagnosis and treatment of MM and related plasma cell disorders (PCD).

Commenting on the guidelines, Paul Duncan, Chief Executive Officer of The Binding Site, said: "The inclusion of FLC levels in the IMWG guidelines is a prestigious endorsement of the significance of our product in the diagnosis and treatment of multiple myeloma and other plasma cell disorders. Not only does the use of Freelite considerably improve the assessment of prognosis in virtually every plasma cell disorder, it also increases the accuracy with which diseases can be monitored, thus improving the overall quality of life for patients. With these guidelines providing valuable information to clinicians, we look forward to the continued uptake of this important product in clinical practice worldwide."

Eric Low, Chief Executive of Myeloma UK, the only organisation dealing exclusively with myeloma and its related disorders in the UK, said: "The publication of IMWG guidelines on the role of the FLC assay in myeloma and other plasma cell disorders is very welcome and represents a significant endorsement for a test which has so many clinical and prognostic positives for patients. I hope that now, this test will be widely used in hospitals throughout the UK."

The consensus guidelines, drawn up by a worldwide group of specialists in MM, set out four major indications for use of Freelite in the diagnosis and management of MM and related PCD:

- In the context of screening, Freelite should be used in combination with serum protein electrophoresis (SPE) and serum immunofixation (IFE) to yield high sensitivity. This obviates the need for analysis of 24-hour urine samples and eliminates the associated patient compliance issues. The single exception to this is when there is a suspicion of AL amyloidosis, in which case a 24-hour urine sample should be run in addition to the serum assays; - The baseline serum FLC measurement can provide important prognostic information in virtually every PCD. Therefore, all patients - including those with monoclonal gammopathy of unknown significance (MGUS) and asymptomatic MM (smouldering MM) patients - should have this test at the point of diagnosis; - Freelite allows for quantitative monitoring of patients: - in AL amyloidosis patients, serial serum FLC measurements are more accurate and sensitive than SPE and IFE alone;. - in non-secretory MM patients, serial serum FLC measurements reduce the need for frequent, painful bone marrow biopsies; - for some intact immunoglobulin MM patients in remission, relapse is accompanied by a phenomenon known as "light chain escape". It is important to detect light chain escape early as it is associated with an increased tumour growth rate, disease progression and a worse prognosis. Without doing periodic urinary evaluations or serum FLC measurements, this phenomenon can be missed; - Normalisation of the serum FLC ratio is required for a stringent complete response according to the IMWG Uniform Response Criteria for MM, anticipated to be widely used in future clinical trials of myeloma.

Notes to Editors:

Authors of International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders

e-Pub reference: Leukemia advance online publication 20 November 2008; doi: 10.1038/leu.2008.307.

A Dispenzieri(1), R Kyle(1), G Merlini(2), JS Miguel(3), H Ludwig(4), R Hajek(5), A Palumbo(6), S Jagannath(7), J Blade(8), S Lonial(9), M Dimopoulos(10), R Comenzo(11), H Einsele(12), B Barlogie(13), K Anderson(14), M Gertz(1), JL Harousseau(15), M Attal(16), P Tosi(17), P Sonneveld(18), M Boccadoro(6), G Morgan(19), P Richardson(14), O Sezer(20), MV Mateos(3), M Cavo(17), D Joshua(21), I Turesson22, W Chen(23), K Shimizu(24), R Powles(25), SV Rajkumar(1) and BGM Durie(26) on behalf of the International Myeloma Working Group.

(1)Departments of Hematology/Laboratory Medicine/Pathology, Mayo Clinic, Rochester, MN, USA; (2)Department of Biochemistry, University Hospital San Matteo, Italy; (3)Department of Hematology, Servicio de Hepatologia, Hospital Universitario de Salamanca, CIC, IBMCC (USAL-CSIC), Spain; (4)1st Medical Department and Oncology, Wilhelminenspital Der Stat Wien, Vienna, Austria; (5)Czech Myeloma Group & Department of Internal Medicine Fn Brno and LF MM Brno, Czech Republic CR; (6)Divisione de Ematologia, University of Torino, Torino, Italy; (7)Department of Medical Oncology/Internal Medicine, St Vincent's Comprehensive Cancer Center, New York, NY, USA; (8)Department of Hematology, Hospital Clinic, IDIBAPS, Barcelona, Spain; (9)Hematology/Medical Oncology, Emory University, Atlanta, GA, USA; (10)Department of Therapeutics, Alexandra Hospital, Athens, Greece; (11)Department of Clinical Laboratories, Memorial Sloan-Kettering Cancer Center, New York, NY, USA; (12)Department of Internal Medicine, University of Wurzburg, Wurzburg, Germany; (13)Departments of Hematology and Pathology, MIRT UAMS, Little Rock, AR, USA; (14)Department of Medical Oncology/Hematologic Malignancies, DFCI, Boston, MA, USA; (15)Department of Hematology, Institute de Biologie, Nantes, France; (16)Departments of Hematology and Biostatistics, Purpan Hospital, Toulouse, France; (17)Institute of Hematology and Medical Oncology, University of Bologna, Bologna, Italy; (18)Department of Hematology, Rotterdam, The Netherlands; (19)Department of Hematology/Oncology, The Leukemia and Myeloma Program, Wimbledon, UK; (20)Department of Hematology/Oncology, University of Berlin, Berlin, Germany; (21)Institute of Hematology, Royal Prince Alfred Hospital, New South Wales, Australia; (22)Department of Hematology/Medicine Malmo University Hospital, Malmo, Sweden; (23)Department of Hematology/OncologyBeijing Chaoyang Hospital, Beijing, China; (24)Department of Internal Medicine, Nagoya City Higashi General Hospital, Nagoya, Japan; (25)Department of Hematology/Oncology, Parkside Cancer Centre, London, UK and (26)Aptium Oncology Inc., Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA.

About Multiple Myeloma

Multiple myeloma is a form of cancer which affects plasma cells in the bone marrow. These are cells which normally produce antibodies and are a specialised form of B-lymphocyte. In myeloma a single cell becomes malignant and produces a very large number of identical cells (a clone). In normal circumstances, the antibody molecules present in the blood are very varied in their structure, reflecting the large number of infections they may be required to combat. In patients with myeloma very large quantities of a single type of antibody are produced. This is called a paraprotein and it is present in the blood and/or urine in about 99% of cases. Normal antibody levels are almost always reduced in myeloma. This, combined with a slight reduction in numbers of neutrophils, leads to a susceptibility to infections which may be life-threatening. When there is no detectable paraprotein it is called non-secretory myeloma. Detection of a paraprotein is not sufficient to give a diagnosis of multiple myeloma, as this may also occur in other conditions including lymphoma, MGUS, amyloidosis and some inflammatory disorders. Source: http://www.lrf.org.uk/en/1/infdispatmul.html.

About AL amyloidosis

AL amyloidosis used to be called 'primary systemic amyloidosis' and is now the most commonly diagnosed form of the disease. Patients with AL amyloidosis have an abnormal line of cells (called plasma or B cells) which are usually in the bone marrow, and which produce the amyloid forming protein. The AL amyloid forming protein is part of a protein called monoclonal immunoglobulin; the part that forms AL amyloid is called the light chain. Abnormal free light chains can be measured in the blood in about 95% of patients with AL amyloidosis. The underlying bone marrow disorder/monoclonal immunoglobulin producing disorder is known by many different names (plasma cell disorder, plasma cell dyscrasia, paraprotein disorder, monoclonal gammopathy, etc), and is very subtle in 80% of patients. In about 20% of patients with AL amyloidosis, the growth of abnormal plasma cells is more florid, and can be overtly cancerous - a condition known as myeloma. Myeloma cells gradually replace healthy bone marrow cells, leading to bone pain and infections. A patient with myeloma may develop (or present with) AL amyloidosis but it is rare for an AL amyloidosis patient (who does not have myeloma at presentation) to progress to advanced myeloma. Source: http://www.ucl.ac.uk/medicine/amyloidosis/nac/nac9.html.

About The Binding Site

The Binding Site Ltd. is a British based company specialising in the research, development and production of immunodiagnostic kits and reagents. The Binding Site manufactures a wide range of high quality and innovative products used in clinical laboratories world-wide. The business is divided into three main areas:-

1) Freelite(TM), a novel and highly significant assay increasingly used for the diagnosis and monitoring of multiple myeloma (MM), a cancer of cells in the bone marrow. MM is the second most common blood cancer after non-Hodgkin's lymphoma. Considered almost untreatable only 20 years ago, huge strides have been made in the successful treatment of multiple myeloma with new drugs becoming available and new treatment regimes being assessed. Freelite has been used as a sensitive marker for the efficacy of some of these newer treatments and has helped clinicians gain a clear understanding of how some of these drugs are benefiting their patients. Furthermore, with numerous different therapies now available, treatment decisions which may have taken weeks or months can now be made in days thanks to the availability of sensitive and reliable results using Freelite. National and International guidelines for the management of multiple myeloma and associated cancers now include Freelite results as a requirement for the diagnosis and monitoring of patients. Numerous clinical trials are underway to look at the use of Freelite in a range of other malignancies as well as how the results may radically change the management of complications such as renal disease in myeloma patients. There are currently approximately 4 million Freelite tests performed per annum with the number of analyses increasing at a rate of approx. 50% p.a. 2) The diagnosis and treatment of patients suffering from autoimmune diseases (caused when the body is unable to distinguish between foreign and self). Many common diseases such as Rheumatoid Arthritis are autoimmune in origin and The Binding Site manufactures a range of diagnostic assays and reagents used in hospital laboratories worldwide to help diagnose and monitor the treatment of these diseases, e.g. antiphospholipid syndrome, vasculitis and coeliac disease. 3) Products used for the detection of immunodeficiency. These include the inherited or acquired disorders of the immune system and products used in donor selection and manufacture of vaccines. The Binding Site has been and remains a market leader in products for the investigation of these diseases. For more information please see http://www.bindingsite.co.uk. Freelite(TM) is a registered Trademark of The Binding Site Ltd., Birmingham, U.K. Enquiries: The Binding Site Paul Duncan Tel: +44-121-436-1000 Financial Dynamics Jonathan Birt / Lara Mott Tel: +44-20-7831-3113

SOURCE The Binding Site Limited

Source: PR Newswire

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