USA, Europe and Japanese Patent Offices turn on Hevylite® switch
Binding Site is delighted to announce the approval of their patent application for their Hevylite® assays, novel laboratory blood tests that enable measurement of intact immunoglobulin heavy/light chains, e.g. IgGκ or IgGλ, in serum. Measurement of immunoglobulin heavy/light chains allows, for the first time, accurate calculation of immunoglobulin heavy/light chain ratios, e.g. IgGκ/IgGλ, an inventive step recognised by Patent Offices in the USA, Europe and Japan.
In continuation of Binding Site’s innovative approach to protein detection in B cell disorders, patents covering the specific Hevylite® antibodies which recognise conformational epitopes, methods to concurrently measure heavy/light chain and free light chains together in multiplex assays, and production of heavy/light chain ratios using ELISA, Flow Cytometry or bead based assays have also been granted.
Hevylite® assays to measure the concentration of each immunoglobulin subtype i.e. IgGκ, IgGλ, IgAκ, IgAλ, IgMκ, IgMλ are CE marked and FDA cleared. The assays are currently in routine use in a number of countries, are being evaluated by many institutions worldwide and have been the subject of more than 20 papers and around 200 poster publications. These new assays overcome many of the issues seen when using traditional electrophoresis methods such as lower sensitivity and co-migration of bands, plus it gives information about the uninvolved heavy/light chain pair, e.g. IgAλ in an IgAκ myeloma patient.
Hevylite® is now incorporated into prestigious guidelines published by the British Committee for Standards in Haematology. This inclusion reflects the increasing number of publications showing the benefits of Hevylite® in a laboratory and clinical setting.