Bluejay Diagnostics Inc. said on Tuesday it has completed enrollment in a clinical study evaluating its rapid sepsis diagnostic test. The trial, conducted across multiple U.S. hospitals, enrolled 1,200 patients suspected of having sepsis, the company said in a statement.
The study is designed to assess the accuracy and reliability of Bluejay’s test, which aims to deliver results within 30 minutes, compared with traditional methods that can take hours. The company seeks to secure U.S. Food and Drug Administration clearance for the test, which could address a critical gap in early sepsis detection.
Sepsis, a life-threatening condition caused by the body’s extreme response to infection, affects millions globally each year and contributes to significant healthcare costs. Rapid diagnosis is widely regarded as key to improving patient outcomes and reducing mortality rates.
Bluejay Diagnostics did not disclose a timeline for FDA submission or potential commercialization. The company’s shares were not immediately active in after-hours trading following the announcement.
