Abingdon Health Ltd Announces the Commercial Launch of Seralite® - FLC the World’s First Rapid Diagnostic Device for Multiple Myeloma

Seralite® - FLC is a rapid diagnostic device for the quantitative measurement of kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in serum as an aid to the diagnosis and management of multiple myeloma. The assay provides an accurate picture of disease status in 10 minutes. Using a simple to use, portable, rapid test, clinicians are able to monitor patients in “real time” supporting faster decision making.

The features of the Seralite®- FLC device provide immediate and empowering benefits to clinicians and laboratory professionals. By obtaining results rapidly, clinicians are able to better understand disease status and can make informed treatment decisions quickly and efficiently.

Use of Seralite® - FLC can facilitate:

• Reduced waiting time for results
• Earlier diagnosis for improved patient outcome
• Fewer clinic visits
• Peace of mind for patient

The Seralite®-FLC assay was developed via a joint venture with Abingdon Health Ltd and the University of Birmingham - Bioscience Ventures (BSVL). Abingdon Health Ltd is a UK based company, with facilities in Birmingham and York, which offers a complementary portfolio of innovative rapid diagnostic products and services. Their core expertise lies in the development and manufacturing of rapid lateral flow diagnostics and reader systems, as demonstrated by the development of Seralite® - FLC.

This commercial launch allows the Company to market the world’s first rapid diagnostic device in multiple myeloma in the 30 countries that comprise the European Union (EU) and the European Free Trade Association (EFTA).

Dr Chris Hand, Chief Executive Officer of Abingdon Health Ltd, commented: ‘We are delighted to commercially launch the Seralite - FLC assay system after an extensive program of testing on clinical samples. This product is one which originated via our joint venture with the University of Birmingham and we are pleased that the combination of scientific and clinical expertise at Birmingham together with our product development and manufacturing expertise have resulted in this product which we believe will, by providing results on-the-spot, aid the monitoring and treatment of patients which will not only benefit the patient but also the health care system’.

About Seralite® - FLC

Seralite - FLC is an easy to use, rapid test that delivers clear, accurate results within ten minutes. It is aimed for use in hospital laboratories and specialist clinics to aid in the diagnosis and monitoring of Multiple Myeloma. It can also be used to help identify and monitor MGUS (Monoclonal Gammopathy of Undetermined Significance) progression. The test measures two markers of myeloma, kappa and lambda free light chains, and calculates the ratio of these two parameters in serum.

The management of Multiple Myeloma and other B Cell Dyscrasia is faced with many challenges including:

• Delay in initial diagnosis
• Delay in identifying treatment response or patient relapse
• Prescribing costly and toxic treatment regimens which potentially may be ineffective

Current practices rely on laboratory based tests to provide information to the clinician for decision making. The time between taking blood samples and receiving laboratory results can vary from a few days to several weeks if the sample is referred to another testing laboratory for analysis of FLC. This delay in result availability can slow down the process of confirming a diagnosis and initiating treatment. A delay in diagnosis of myeloma can result in serious complications such as renal failure and spinal damage.

About Multiple Myeloma

Multiple Myeloma is the 2nd most common form of hematological malignancy. It can present in many different ways, and is typically a disease of the elderly but it can also occur in the young. Bone pain and fractures are characteristic and patients can develop renal failure, acute and chronic infections. Many will require stem cell transplantation and/or intensive chemotherapy. Because of this many clinical specialists such as hematologists, nephrologists, immunologists, orthopedic surgeons and chemical pathologists become involved in patient care. Rapid diagnosis and early treatment can prevent the development of these severe complications of myeloma and as a result can greatly improve quality and duration of life.