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USA, Europe and Japanese Patent Office’s Turn on Hevylite® Switch

21 Mar 2014
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

Patents granted for Hevylite assays and antibodies

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.

Download your free copy of the BCSH Guidelines here: http://www.bcshguidelines.com/documents/MYELOMA_GUIDELINE_updated_29_aug_RG_jzw_(3).pdf

For more information on Hevylite® assays, please click on the 'request information' tab below.

Tags

HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.

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USA, Europe and Japanese Patent Office’s Turn on Hevylite® Switch