Freelite® serum free light chain analysis
Freelite® is a major breakthrough for the detection and monitoring of Multiple Myeloma (MM) and other B-cell dyscrasias. Freelite assays were developed by Binding Site to measure free lambda and free kappa immunoglobulin light chains. Our expertise in the manufacture of antibodies has enabled us to provide a quantifiable, highly specific, automatable free light chain assay for serum.
Significant clinical evidence indicates the benefit of Freelite® serum free light chain assays in initial screening for monoclonal gammopathies, identifying AL amyloidosis and Nonsecretory MM patients missed by conventional electrophoretic methods, as a prognostic indicator for progression in myeloma, for risk stratification of MGUS patients and rapid evaluation of treatment efficacy.
Freelite® is a sensitive, specific marker of kappa and lambda free light chains (FLC) in serum and provides quantitative measurement of:
- Free Kappa in serum
- Free Lambda in serum
- The serum free Kappa/free Lambda ratio
The Freelite® serum free light chain ratio is a strong indicator of monoclonality and is valuable for distinguishing monoclonal from polyclonal diseases.
In 2009 the International Myeloma Working Group published guidelines recommending the measurement of serum free light chain concentrations as an aid in the diagnosis, prognosis and monitoring of multiple myeloma patients.
The advice was given based upon results obtained in extensive clinical trials using the polyclonal Freelite® assays.1
Key recommendations are:-
- Recommended for the use of the serum FLC assay in screening
- Recommended for the use of the serum FLC assay in prognosis
- Recommended for the use of the serum FLC assay in response assessment
A recent report by Katzmann et al2 recommends a simplification of the plasma cell dyscrasia diagnostic algorithm mentioned in current International Myeloma Working Group guidelines indicating that only serum protein electrophoresis (SPE) and Freelite® free light chain (FLC) tests may be needed in many cases.
"...because of the small incremental sensitivity provided by urine studies and serum IFE, the use of PEL [SPE] plus FLC provides a simple and efficient initial diagnostic screen for the high-tumour-burden monoclonal gammopathies such as MM [multiple myeloma], WM and SMM [smouldering multiple myeloma]. Urine studies and serum IFE can be ordered more selectively."
Hevylite® immunoglobulin heavy chain/light chain analysis
Hevylite®* (HLC), a new assay now available from Binding Site, promises to transform the way patients with B cell dyscrasia are managed, just as the Freelite® assay has done.
In summary Hevylite® assays offer:
- Higher sensitivity than serum protein electrophoresis for quantifying monoclonal immunoglobulins
- Numerical results for patients at a sensitivity as high as or better than immunofixation electrophoresis
- Clinical value when monitoring patients with monoclonal gammopathies
- HLC ratios which have a greater range of changes than monoclonal immunoglobulin measurements because the non-tumour immunoglobulin allows assessment of immunosuppression
- HLC ratios which are not affected by changes in blood volume, haematocrit and variable metabolism (via FcRn receptors for IgG) that affect current assays for serum immunoglobulins
- HLC ratios that provide information about the tumour selective killing rate versus non-tumour plasma cell kill rates. The assessment of selective tumour killing rates may help with decision making regarding effective chemotherapies