Novel improvements in the diagnosis of plasma cell disorders

Offentlig prosjektsammendrag

Plasma cell disorders are serious diseases such as multiple myeloma (a blood cell cancer from which hundreds of thousands of people die annually) and AL-amyloidosis (a multi-organ cancer with limited life expectancy). Early diagnosis of these conditions or of known precursors of these conditions (such as MGUS) can be vital for appropriate treatment and for an improved prognosis. Diagnosis is based on detection of biomarkers known as free light chains (FLC) that are detected in blood samples of patients using immunoturbidimetric assays. Different versions of the FLC assay are available and are widely used, but they have analytical issues related to specificity, sensitivity, and linearity; in addition, lot-to-lot and inter-analyzer variations have been documented. Thus, one important diagnostic challenge is that a patient sample analysed by one assay and found to have a high value, may give a low signal, or even be negative, when checked using another assay. Another problem is that controls and calibrators provided with assay kits are specific for that kit alone; with a lack of kit-independent standard materials it is virtually impossible to compare different assays. In our project, we not only aim to produce an improved diagnostic kit, based on specific antibody generation, but also prepare and commercialise a set of calibrators and controls suitable for using with all kits on all platforms, such that the different assays can be compared and standardized. Both these developments will be invaluable for diagnosis of these disorders, such that appropriate treatment can be commenced at an early stage and patients can be appropriately monitored. Hospitals in the Nordic region have already expressed their interest in our work and the development of these useful additions to the diagnostic toolbox.