Freelite®, a unique and highly 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 15,000 new cases of Multiple Myeloma and associated types of cancer expected to be diagnosed during 2007 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 analysers. It consists of two reagents, each one being specific for one of the two types of potential tumour marker 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 chain separately greatly enhances the utility of Freelite and is a unique feature of this test.

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

Only 20 years ago the prognosis for Multiple Myeloma patients was generally poor. However, huge strides have been made in the successful treatment of Multiple Myeloma with new drugs becoming available and new treatment regimes being assessed. Freelite® has been used as a sensitive marker for the efficacy of some of these newer treatments and has helped clinicians gain a clear understanding of how these drugs are benefiting their patients. Furthermore, with numerous different therapies now available, treatment decisions which may have taken weeks or months can now be made in days thanks to the availability of sensitive and reliable results using Freelite®. National and International guidelines for the diagnosis and treatment of Multiple Myeloma and associated cancers now include Freelite® results as a requirement for monitoring the treatment of patients.

Trials are underway looking at the use of Freelite® in a range of other haematological 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 analyser - the SPAplus Specialist Protein Analyser optimised for running Freelite®, Hevylite® and other high sensitivity assays

In 2009 we developed a range of assays complimentary to Freelite® called Hevylite® which are specifically optimised to run on the SPAplus analyser. These Hevylite® assays are, like Freelite®, used in the diagnosis and monitoring of B cell dyscrasia. By utilising the entire panel of Freelite and Hevylite® tests clinicians can gain valuable information about the type and stage of the disease as well as the efficacy of different treatment regimes.

Preliminary results of other assays developed utilising the proprietary technology employed to manufacture Freelite® have shown extremely promising results. In the future we will look to validate these and other tests for use in the measurement of additional cancer markers and diagnostically important proteins.

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 specialised products for the diagnosis of primary immunodefiency 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. Our range of assays can be used as effective aids in the diagnosis of PID and 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 optimised for use by manufacturers of therapeutic immunoglobulin preparations, based upon the same technology as the investigative tests.