Serascience Launches World’s First Point-of-Care Diagnostic Device for Multiple Myeloma

2 May 2013
Sonia Nicholas
Managing Editor and Clinical Lead

Serascience Limited (“Serascience” or “the Company”), a specialist cancer diagnostics company established by a joint venture between Abingdon Health and the University of Birmingham, has announced the launch of SeraliteTM, its proprietary point-of-care diagnostic device for multiple myeloma. The device will initially be available for research use only, followed by CE marking and application for FDA approval.

SeraliteTM will be used to aid the diagnosis of myeloma and to monitor relapse and MGUS (Monoclonal gammopathies 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 urine, blood or serum.

Multiple myeloma is the second most common type of blood cancer with approximately 1,000 new cases diagnosed daily on a global basis. The disease has a high rate of deterioration and a poor prognosis. Delays in diagnosis can result in anaemia, infection and severe damage to the kidneys and skeleton. Studies show that when first diagnosed, up to 40% of myeloma patients may already be experiencing renal failure. 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.

The current clinical practice involves sending test samples to laboratories for analysis and waiting up to ten days for the results. SeraliteTM is an easy to use, point-of-care device that delivers clear, accurate results within ten minutes. It will enable clinicians to quickly respond to results, allowing them to immediately start treatment and potentially assess whether a current treatment regime is working. It will also provide economic benefits by reducing the number of outpatient visits and enabling faster tracking of disease progression.

Professor Mark Drayson, Director Clinical Immunology Service at University of Birmingham, commented: “Early diagnosis is critical for patients with myeloma. In the UK approximately 4,000 new cases of myeloma are diagnosed every year. The faster the treatment process can begin, the greater the chance of survival. Currently 50% of patients with myeloma require three or more visits to their GP before they are referred to hospital. The launch of a point-of-care test is an important step in improving patient outcomes and we welcome this development.”

Dr Chris Hand, Chief Executive Officer of Abingdon Health and Serascience, commented: “SeraliteTM will provide clinicians with an immediate result that will enable them to quickly start or change treatment options. It is the first device of its kind and we are excited by its potential to help improve outcomes for patients currently suffering with myeloma.”

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