PlateletDiagnostics Announces Novel Immune-Based Platelet Function Assay to Monitor Antiplatelet Therapy

WATERTOWN, Mass., April 6, 2026 /PRNewswire/ -- PlateletDiagnostics, LLC (PlateletDx.com) today 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 specialized expertise, dedicated instruments, and expensive consumables that limit their use in routine clinical practice. PlateletDiagnostics' assay is performed on standard laboratory ELISA equipment, processes whole blood samples, and is designed to fit seamlessly into existing laboratory workflows. This approach enables laboratories to freeze, batch and later analyze 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 specialized centers."

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 lab infrastructure, position the technology as a scalable solution for large patient populations receiving antiplatelet drugs.

"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."

PlateletDiagnostics is currently advancing the assay through further clinical validation and exploring options to support regulatory submission and commercialization. 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.

About PlateletDiagnostics, LLC
Founded by leaders in platelet biology at Harvard Medical School, PlateletDiagnostics is a privately held company developing next-generation platelet function diagnostics positioned to address major unmet needs in antiplatelet monitoring and platelet function testing. By combining immune-based detection with standard laboratory platforms, the company delivers sensitive, convenient, and cost-effective assays.

SOURCE PlateletDiagnostics, LLC