Unmet Need
· A large proportion of patients with bleeding disorders fail to be diagnosed, and are classified as having bleeding of unknown cause due to a lack of sensitive assays for detecting abnormalities in fibrinolytic factors (Mehic et al. 2021). In addition, patients with young-onset or unprovoked venous thromboembolism, as well as those with young-onset or cryptogenic ischemic stroke, often have a non-informative or unrevealing routine clinical laboratory workup for hypercoagulable states and may warrant evaluation of plasma fibrinolytic function of hypofibrinolytic states. The euglobulin clot lysis assay (ECLA) is currently used, but is slow, labor intensive, and has low sensitivity. Thus, there exists a strong need for developing a new assay that is high throughput, sensitive, and replicable to address the limitations of current ECLA.
Value Proposition:
· Detection in 75 microliters of patient plasma, compared to 350 microliters in standard ECLA
· Higher sensitivity: detection of hyperfibrinolysis in alpha 2 antiplasmin deficient plasma not previously detectable
· Higher throughput: up to 48 samples can be run in parallel
Technology Description
· Current methods for detecting fibrinolytic factor abnormalities see limited clinical use due to low sensitivity and high labor and time costs. Researchers at Johns Hopkins have developed a high throughput, mini-scale ECLA assay to address these shortcomings. The method involves a series of semi-automated acidification, centrifugation, and wash steps followed by resuspension of the resulting euglobulin fraction pellet and measurement of lysis times through spectrophotometry. Data demonstrates comparable or greater sensitivities than standard ECLA at lower sample volumes and higher throughput.
Stage of Development
· In vitro trials are ongoing and demonstrate preliminary analytic sensitivity while allowing for significant sample preservation, greater automation, and higher throughput.
· Current efforts focus on characterizing reproducibility and sensitivity, decreasing running times, and developing companion software.
Data Availability
· Data available upon request.
Publication
N/A
