Hevylite is FDA cleared to help monitor patients with IgG and IgA myeloma

April 11, 2014

Binding Site’s novel laboratory blood assays for intact immunoglobulins, Hevylite, has been 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.

According to company representatives, 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, these assays may aid in identifying residual disease and relapse in some patients. 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—for example, when there are 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.

These assays are also CE marked and are 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 some 200 abstract and poster publications. Learn more about Hevylite.

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