Perosphere Technologies Reports New Clinical Data for ClotChek

Cambridge, United Kingdom, September 8, 2026

Clinical Study Evaluates Point-of-Care Anticoagulant Measurement

ClotChek is designed to provide rapid assessment of coagulation status in patients taking Factor Xa inhibitors, a class of anticoagulant medicines that includes apixaban, rivaroxaban and edoxaban. The technology is intended to help clinicians determine whether clinically relevant anticoagulant activity is present when laboratory testing may not be immediately available. The prospective study examined the performance of ClotChek in patients treated with direct oral anticoagulants. Researchers assessed the device’s ability to detect and quantify anticoagulant effects using whole-blood samples, comparing its measurements with established laboratory testing approaches. The results add clinical evidence to the potential role of rapid point-of-care coagulation assessment in situations where knowing a patient’s anticoagulant status can influence treatment decisions. The clinical relevance is particularly important in emergency settings. Patients taking Factor Xa inhibitors may present with major bleeding, acute stroke, trauma or a need for urgent surgery, where clinicians must rapidly determine the extent of anticoagulant activity. Conventional laboratory testing can require specialized equipment and may not always provide results quickly enough for time-sensitive decisions.

Rapid Testing Could Support Emergency Clinical Decisions

The development of ClotChek addresses an important challenge created by the growing use of direct oral anticoagulants. Although these medicines offer advantages over older anticoagulants, their presence can complicate emergency treatment when patients experience serious bleeding or require an urgent procedure. A rapid point-of-care test could potentially provide clinicians with actionable information without waiting for a centralized laboratory result. ClotChek uses a whole-blood testing approach intended to generate results close to the patient, potentially supporting faster assessment and treatment decisions. The company behind the technology has positioned ClotChek as a tool for situations where conventional testing infrastructure may be unavailable or too slow. The device is designed to be compact and suitable for use in settings such as emergency departments, operating rooms, stroke centers and other acute-care environments. However, clinical implementation requires careful interpretation. A point-of-care measurement is intended to complement clinical assessment and should be considered alongside the patient’s medication history, timing of the last dose, renal function, bleeding status and other relevant factors. The reported study therefore represents an important addition to the evidence base but does not by itself establish ClotChek as a replacement for all conventional laboratory testing.

Clinical Evidence Builds MedTech Development Program

The new publication adds to the growing body of clinical evidence supporting rapid coagulation testing technologies. The ability to measure anticoagulant activity directly from whole blood could be particularly valuable as DOAC use continues across cardiovascular and thromboembolic indications. ClotChek has obtained CE marking in Europe, supporting its availability in applicable European markets. The technology’s regulatory status and availability vary by jurisdiction, and the device should not be described as FDA-cleared unless and until the appropriate U.S. regulatory authorization is obtained. The new evidence also demonstrates the importance of prospective clinical evaluation for diagnostic and point-of-care technologies. Beyond analytical performance, studies involving real patients can help determine how reliably a device performs across different anticoagulant exposures and clinical circumstances. For cGxP.wire readers, the ClotChek findings illustrate the intersection of MedTech, diagnostics, anticoagulation management and emergency medicine. As healthcare systems seek faster diagnostic information at the bedside, technologies capable of delivering clinically relevant measurements without centralized laboratory delays could play an increasingly important role. The latest clinical evidence does not establish a new pharmaceutical treatment, but it strengthens the scientific and clinical foundation for point-of-care Factor Xa inhibitor assessment and highlights the potential value of rapid coagulation diagnostics in time-sensitive care.

Source: Perosphere press release