New Platelet Function Assay Enables Monitoring of Antiplatelet Therapy

Aggregation-based assays and cartridge systems often require specialized personnel, dedicated instruments, and costly consumables, limiting routine use outside specialized centers. A new ELISA-based approach now provides a practical alternative for monitoring antiplatelet therapy by quantifying phosphorylation changes in a key platelet protein.

PlateletDiagnostics has announced the development of a first-in-class platelet function assay that measures phosphorylation of dynamin-related protein 1 (Drp1) using an enzyme-linked immunosorbent assay (ELISA). The technology is licensed from Beth Israel Deaconess Medical Center and is supported by a recent publication in Blood indicating that Drp1 phosphorylation provides a robust platform for immune-based platelet function testing.

The assay employs proprietary antibodies to detect dual-site phosphorylation of Drp1, a highly abundant platelet guanosine triphosphatase whose phosphorylation state shifts in response to platelet agonists and antiplatelet agents. Designed for standard laboratory ELISA equipment, it processes whole blood and fits into existing workflows. Laboratories can freeze, batch, and subsequently analyze samples, reducing technician time and overall cost compared with competing methods.

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. Across these studies, the ELISA performed comparably to light transmission aggregometry and point-of-care tests, demonstrating sensitivity and specificity comparable to or better than established assays. The signal remained stable under conditions that commonly degrade other platelet markers and showed enhanced dynamic range and signal-to-noise relative to cartridge-based tests.

Because Drp1 integrates signals from multiple pathways, the platform can be adapted to interrogate platelet function across diverse clinical scenarios where platelet reactivity is relevant. Additional features include low per-test cost and compatibility with existing laboratory infrastructure. The company is advancing further clinical validation and exploring options for regulatory submission and commercialization; proprietary antibodies and assay design are covered by intellectual property licensed from Beth Israel Deaconess Medical Center.

“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 specialized centers.”

“PlateletDiagnostics is building a platform around post-translational modification–based diagnostics, starting with Drp1 for platelet function,” said Michael Cerio, interim CEO of PlateletDiagnostics. “We believe this simple antibody-based testing approach has the potential to streamline how clinicians manage antiplatelet therapy by delivering rapid, actionable information using tools labs already run at scale, while opening a path to additional platelet and cell-function indications over time.”

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