Bluejay Diagnostics, Inc.

Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes in critical care settings, specifically sepsis. The company is developing rapid, near-patient tests using whole blood on its Symphony technology platform. The Symphony platform consists of an analyzer and single-use protein detection cartridges. Bluejay Diagnostics does not yet have regulatory clearance for Symphony and requires authorization from the U.S. Food and Drug Administration (FDA) before marketing it as a diagnostic product in the United States. The pre-clinical development of the Symphony analyzer has been completed. In 2026, the company transferred the knowledge, technology, and process for producing Symphony cartridges from the original developer and outside supplier, Toray Industries, to a contract manufacturing facility with FDA certification run by Sanyoseiko. Bluejay Diagnostics is collaborating with Sanyoseiko to modify the manufacturing process of the Symphony cartridges to address technical issues and meet performance and quality requirements for regulatory submission. The Symphony platform combines Bluejay's intellectual property and exclusively licensed and patented intellectual property on the Symphony technology. The Symphony device candidate is designed to produce laboratory-quality results in approximately 20 minutes in critical care settings, including Intensive Care Units (ICUs) and Emergency Rooms (ERs). The company's first product candidate, the Symphony IL-6 test, is an immunoassay for measuring interleukin-6 (IL-6) to monitor disease progression in critical care settings, with a current focus on sepsis.