New screening test for thrombosis in lupus patients
Patients with SLE, an autoimmune disease, are at high risk of thrombosis, a life-threatening complication of SLE. Accurate identification of these patients is crucial to ensure optimal benefits from preventive measures to stop blood clotting and thrombosis using anticoagulant prophylaxis, due to a better risk/benefit ratio. SLE is characterised by the production of anti-nuclear antibodies and extensive tissue inflammation. Thrombotic events raise healthcare costs significantly as it includes direct cost for interventions and rehabilitation cost. Furthermore, the total median costs for prophylaxis are estimated to be four times lower than thrombotic event management. Current testing methods fail to accurately assess the risks for SLE thrombosis in these patients. Applying its unique expertise in functional analysis of blood plasma and cellular components, the Dutch laboratory Good Biomarker Sciences (GBS) has developed ThromboSLE, an innovative test to assess thrombosis risk in SLE with high sensitivity and specificity. The objectives of the ThromboSLE project were also to assess the technical feasibility of this methodological approach. Detecting thrombosis risk in SLE patients ThromboSLE will allow more accurate risk assessment of thrombotic episodes that may occur in SLE subjects. “Our goal was to investigate the relationship between circulating autoantibodies and tissue factor, a protein involved in clotting, as an indicative marker for high risk incidence of thrombosis in lupus patients,” explains Dr Tasev, ThromboSLE project coordinator. The team has worked on development of an assay that generates tissue factor in response to thrombogenic triggers, that is stimuli that cause thrombosis. “One of the main obstacles that we encountered was the interference of clotting with our downstream analysis of collected material,” adds Tasev. The research team was able to eliminate clotting interference, although this reduced the responsiveness of the cells to external stimuli (patient material) that could generate tissue factor. Another project goal was to establish good communication with key opinion leaders (KOLs) in the lupus area to expand their capabilities for acquisition of scarce patient material. Several KOLs supported ThromboSLE by sending patient material for testing while others expressed their willingness to participate in future development of the test as well as in its clinical validation. Thrombosis events prediction – Reduced costs and financial benefits Apart from reducing morbidity and mortality from thrombosis-related complications, ThromboSLE can significantly reduce healthcare costs. This opens a strong business opportunity for GBS, which aims to offer the test to hospitals treating and monitoring SLE patients in Europe and worldwide. The commercial exploitation of the diagnostic product will have substantial impact on GBS with regard to company growth and business strategy. ‘‘We will proceed with the testing of patient material devoid of clotting factors and with validation of our findings in another reporter cell line that closely mimics the in vivo mechanisms of thrombosis in lupus patients,’’ concludes Tasev. GBS aims to conduct a feasibility study for final verification of the technological aspects, as well as the product economic viability. ThromboSLE members plan to offer this test as a service based on the centralised laboratory of GBS. With 160 000 SLE patients in the target market of western Europe, GBS forecasts indicate they expect to generate cumulated profits of EUR 6.6 million from ThromboSLE sales by 2025.
Keywords
ThromboSLE, thrombosis, systemic lupus erythematosus (SLE), diagnostic, clinical validation, healthcare cost, feasibility study
