B Cell Dyscrasias

Freelite® is a unique and significant assay increasingly used for the diagnosis and monitoring of Multiple Myeloma, a cancer of cells in the bone marrow. Multiple Myeloma is the second most common blood cancer after non-Hodgkin's lymphoma.

There are 20,500 new cases of Multiple Myeloma and associated types of cancer expected to be diagnosed in 2010 in the USA alone. Worldwide, Multiple Myeloma accounts for 0.8% of all cancer deaths with approximately 86,000 new cases per year.

Freelite® is an increasingly common test offering significant advantages over current laboratory assays for detection and monitoring of Multiple Myeloma. The test is performed on a serum sample in a laboratory on standard automated laboratory analyzers. It consists of two reagents, each one being specific for one of the two types of potential tumor markers secreted by cancerous myeloma cells: kappa free light chains or lambda free light chains. The results are reported as three values: the kappa free light chain level, the lambda free light chain level, and as a kappa to lambda ratio. The ability to measure the two types of light chains separately greatly enhances the utility of Freelite and is a unique feature of this test.

Although numerous companies have tried over many years to devise ways of distinguishing and measuring these free light chain proteins in serum, only Binding Site has been able to develop assays suitable for routine clinical practice.

Trials are underway looking at the use of Freelite® in a range of other hematological malignancies. These include applications in renal medicine which may radically improve outcomes for cancer patients with renal complications.

Currently there are approximately 3.3 million pairs of Freelite® tests performed annually worldwide (Aug 10) with the number of analyses increasing at a rate of around 30% per year.

An important step allowing access to the assay across all clinical laboratories was the introduction in late 2007 of our own turbidimetric bench top analyzer - the SPAPLUS Specialist Protein Analyzer optimized for running Freelite® and other high sensitivity assays.

Detection of Immunodeficiency

Binding Site is a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.

Of particular importance are a range of specialized products for the diagnosis of primary immunodeficiency disease. Primary immunodeficiency diseases (PID) are disorders in which part of the body's immune system is missing or does not function properly. In contrast to secondary immunodeficiency diseases in which the immune system is compromised by factors outside the immune system, PID are caused by intrinsic or genetic defects in the immune system.

Because of advances in the understanding and treatment of primary immunodeficiency diseases, individuals who in the past would not have survived beyond childhood are now able to live nearly normal lives. A worldwide increase in awareness of these diseases has led to an increase in the number of tests performed. Additionally we have developed a further range of assays, specifically optimized for use by manufacturers of therapeutic immunoglobulin preparations, based upon the same technology as the investigative tests.