International Guidelines for First-Line use of Freelite®
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® 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 quantiative 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.
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 Dispenzieri1, R Kyle1, G Merlini2, JS Miguel3, H Ludwig4, R Hajek5, A Palumbo6, S Jagannath7, J Blade8, S Lonial9, M Dimopoulos10, R Comenzo11, H Einsele12, B Barlogie13, K Anderson14, M Gertz1, JL Harousseau15, M Attal16, P Tosi17, P Sonneveld18, M Boccadoro6, G Morgan19, P Richardson14, O Sezer20, MV Mateos3, M Cavo17, D Joshua21, I Turesson22, W Chen23, K Shimizu24, R Powles25, SV Rajkumar1 and BGM Durie26 on behalf of the International Myeloma Working Group.
1Departments of Hematology/Laboratory Medicine/Pathology, Mayo Clinic, Rochester, MN, USA; 2Department of Biochemistry, University Hospital San Matteo, Italy; 3Department of Hematology, Servicio de Hepatologı´a, Hospital Universitario de Salamanca, CIC, IBMCC (USAL-CSIC), Spain; 41st Medical Department and Oncology, Wilhelminenspital Der Stat Wien, Vienna, Austria; 5Czech Myeloma Group & Department of Internal Medicine Fn Brno and LF MM Brno, Czech Republic CR; 6Divisione de Ematologia, University of Torino, Torino, Italy; 7Department of Medical Oncology/Internal Medicine, St Vincent’s Comprehensive Cancer Center, New York, NY, USA; 8Department of Hematology, Hospital Clinic, IDIBAPS, Barcelona, Spain; 9Hematology/Medical Oncology, Emory University, Atlanta, GA, USA; 10Department of Therapeutics, Alexandra Hospital, Athens, Greece; 11Department of Clinical Laboratories, Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 12Department of Internal Medicine, University of Wurzburg, Wurzburg, Germany; 13Departments of Hematology and Pathology, MIRT UAMS, Little Rock, AR, USA; 14Department of Medical Oncology/Hematologic Malignancies, DFCI, Boston, MA, USA; 15Department of Hematology, Institute de Biologie, Nantes, France; 16Departments of Hematology and Biostatistics, Purpan Hospital, Toulouse, France; 17Institute of Hematology and Medical Oncology, University of Bologna, Bologna, Italy; 18Department of Hematology, Rotterdam, The Netherlands; 19Department of Hematology/Oncology, The Leukemia and Myeloma Program, Wimbledon, UK; 20Department of Hematology/Oncology, University of Berlin, Berlin, Germany; 21Institute of Hematology, Royal Prince Alfred Hospital, New South Wales, Australia; 22Department of Hematology/Medicine Malmö University Hospital, Malmö, Sweden; 23Department of Hematology/OncologyBeijing Chaoyang Hospital, Beijing, China; 24Department of Internal Medicine, Nagoya City Higashi General Hospital, Nagoya, Japan; 25Department of Hematology/Oncology, Parkside Cancer Centre, London, UK and 26Aptium Oncology Inc., Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA, USA.