PlateletDiagnostics has announced the development of a first-in-class platelet function assay that measures phosphorylation of the abundant platelet protein, dynamin-related protein 1 (Drp1) using a simple ELISA format that offers a practical alternative to traditional aggregation-based tests for monitoring antiplatelet therapy.
The technology, licensed from Beth Israel Deaconess Medical Center (BIDMC), is supported by a recent publication in Blood demonstrating that Drp1 phosphorylation provides a robust platform for immune-based platelet function testing.
Current platelet function assays rely on light transmission aggregometry or proprietary cartridge-based systems, which require specialised expertise, dedicated instruments, and expensive consumables that limit their use in routine clinical practice. PlateletDiagnostics' new assay is performed on standard laboratory ELISA equipment, processes whole blood samples, and is designed to fit into existing laboratory workflows. This approach enables laboratories to freeze, batch and later analyse samples, reducing technician time and overall cost compared with competing methods.
The new assay leverages dual-site phosphorylation of Drp1, a highly abundant platelet GTPase whose phosphorylation state changes in response to both platelet agonists and antiplatelet agents. Using proprietary antibodies developed by PlateletDiagnostics, the ELISA provides a sensitive readout of platelet reactivity that was shown to perform comparably to aggregometry and point-of-care tests in clinical studies of aspirin and clopidogrel therapy. Because Drp1 integrates signals from multiple pathways, the platform can be adapted to interrogate platelet function in a broad range of clinical scenarios where platelet reactivity is important.
"Antiplatelet medications are prescribed to millions of patients to prevent heart attacks and strokes, but we lack an inexpensive, scalable way to monitor whether individual patients are adequately inhibited or resistant to therapy," said Robert Flaumenhaft MD PhD, Professor of Medicine and Chief of the Division of Hemostasis and Thrombosis at BIDMC, and co-founder of PlateletDiagnostics. "By bringing a platelet function test onto standard ELISA platforms, we aim to make antiplatelet monitoring accessible to any hospital laboratory, not just specialised centres."
In proof-of-principle clinical studies, the Drp1 phosphorylation ELISA tracked reductions and recovery of platelet function during initiation and washout of aspirin and clopidogrel therapy, demonstrating sensitivity and specificity comparable to or better than established assays. The assay maintained signal stability under conditions that commonly degrade other platelet markers and showed enhanced dynamic range and signal-to-noise relative to cartridge-based tests. These features, together with low per-test cost and compatibility with existing laboratory infrastructure, position the technology as a scalable solution for large patient populations receiving antiplatelet drugs.
PlateletDiagnostics is currently advancing the assay through further clinical validation and exploring options to support regulatory submission and commercialisation. The company's proprietary antibodies and assay design are covered by intellectual property licensed from BIDMC, with additional company-developed reagents supporting a differentiated competitive position in platelet diagnostics.