Hevylite® FDA Cleared to Help Monitor Patients with IgG and IgA Myeloma

11 Apr 2014
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Hevylite assay may offer unique advantages in the monitoring of residual disease and myeloma

Binding Site’s novel laboratory blood assays for intact immunoglobulins, Hevylite®, have recently become the only automated immunoassay cleared by the FDA for monitoring IgA and IgG Multiple Myeloma patients.

Hevylite® measures the concentration of each immunoglobulin subtype i.e. IgGκ, IgGλ, IgAκ, IgAλ, IgMκ, IgMλ using a rapid, quantitative method. These measurements are used to produce immunoglobulin heavy/light chain ratios, e.g. IgGκ/IgGλ, similar to Free Light Chain κ/λ ratios when using Freelite®.

The assays can overcome issues with serum protein electrophoresis including problems due to co-migration (commonly seen in IgA myeloma patients) and inaccuracies due to low or high levels of monoclonal protein. In addition, reports1-3 suggest these assays may aid in identifying residual disease and relapse in some patients. Uniquely, Hevylite® also gives information about the uninvolved heavy/light chain pair e.g. IgAλ in an IgAκ myeloma patient.

Hevylite® can help when results from serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) are difficult to interpret; this includes problems due to co-migration of monoclonal bands, lower sensitivity/high variation at low levels of monoclonal protein (<10g/L) and non-linearity due to gel dye saturation.
In a number of publications,1-3 Hevylite® showed disease relapse in Multiple Myeloma patients some months before a monoclonal protein could be detected using SPE and IFE. Results indicate that it is the unique ability to measure suppression of the uninvolved Hevylite® pair which adds sensitivity to this assay both for relapse and in detecting residual disease.

These assays are also CE marked and currently in routine use in a number of countries. Hevylite® is being evaluated by many institutions worldwide and has been the subject of more than 20 papers and around 200 abstract and poster publications.

Hevylite® is also mentioned in prestigious guidelines published by the British Committee for Standards in Haematology. This reflects the increasing number of publications showing the benefits of Hevylite® in a laboratory and clinical setting. Download your free copy of the BCSH Guidelines here: http://www.bcshguidelines.com/documents/MYELOMA_GUIDELINE_updated_29_aug_RG_jzw_(3).pdf

References

1.Ludwig H, et al. Immunoglobulin heavy/light chain rations improve paraprotein detection and monitoring, identify residual disease and correlate with survival in multiple myeloma patients. Leukemia 2013, 27: 213-219

2.Lakomy D, et al. Évaluation de nouveau test HevyliteTM IgA dans le diagnostic et le suivi des gammapathies monoclonales. Ann Biol Clin 2013, 71: 157-163. For an English version request a free copy of MKG696 here: http://www.bindingsite.com/literature

3.Donato LJ, et al. A 71-Year-Old Woman with Multiple Myeloma Status after Stem Cell Transplantation. Clinical Chemistry 2011, 57: 1645-1649

*In Europe, the USA and Canada Hevylite® is a registered trademark of The Binding Site Group Ltd.

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Sonia Nicholas
Clinical Diagnostics Editor