Ten minutes vs Ten days: CE Mark for World’s First Point-of-Care Multiple Myeloma Diagnostic Device

Specialist UK cancer diagnostics company Serascience Limited has received CE Mark approval for the commercial sale of Seralite®, its proprietary point-of-care diagnostic device for multiple myeloma. The approval means ten minute diagnosis of the disease, compared with ten days.

Background

The formation of Serascience Ltd. was the result of a joint venture between Abingdon Health and the University of Birmingham, UK. It is a specialist cancer diagnostic company developing fast, accurate point-of-care tests to aid the diagnosis of myeloma and related conditions. Serascience also supplies a broad range of class and subclass specific anti immunoglobulin antibodies.

Multiple myeloma is the second most common type of blood cancer with 1,000 new cases diagnosed globally every day. 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.

Diagnosis of myeloma currently involves sending test samples to laboratories for analysis and waiting up to ten days for the results. In contrast, Seralite will allow clinicians to quickly respond to results, allowing them to immediately start treatment and potentially assess if 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.

In the press release that announces the CE marking, Serascience describes Seralite as an easy to use, point-of-care device that delivers clear, accurate results within ten minutes. It is aimed for use in hospitals and specialist clinics 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 or serum.

Product evaluations are currently being carried out in key clinics across the UK, and discussions are underway with a number of international distributors.

Company comments

Dr Chris Hand, Chief Executive Officer of Abingdon Health and Serascience, commented: “The European approval of our first point-of-care product is a significant achievement, marking a key point in the continued growth of our company. Multiple myeloma is the second most common type of blood cancer and we believe Seralite has the potential to help improve outcomes for patients by providing clinicians with an immediate result that will enable them to quickly start or change treatment options. Since the test was launched for research in April, we have seen growing interest from the myeloma community and we look forward to rolling it out across Europe.”

Source: Serascience Ltd.