Bluejay Hits Key Milestone in Race for Rapid Sepsis Test

NEW YORK, NY – December 29, 2025 – In a critical step toward addressing one of modern medicine’s deadliest and most costly conditions, Bluejay Diagnostics, Inc. (NASDAQ: BJDX) has announced the completion of commercial-scale production of key antibodies for its rapid sepsis diagnostic test. This manufacturing achievement marks a significant de-risking milestone for the company's Symphony™ System, a near-patient platform designed to deliver results in approximately 20 minutes. The news, however, arrives as the company navigates a challenging financial landscape and a multi-year path toward potential regulatory approval.

Sepsis, the body's overwhelming and life-threatening response to an infection, affects over 1.7 million people in the United States annually and is a leading cause of hospital deaths worldwide. The condition is notoriously difficult to diagnose quickly, as current methods often rely on pathogen detection that can take days. This delay can be fatal, making the quest for a rapid and reliable diagnostic tool a top priority in critical care.

Securing a Critical Component

Bluejay’s announcement centers on the successful production of both polyclonal and monoclonal antibodies targeting Interleukin-6 (IL-6), a key protein biomarker that signals inflammation. According to the company, the antibodies have met all internal performance criteria and are ready for integration into the Symphony testing cartridges.

Crucially, the current inventory is reportedly sufficient to produce over nine million cartridges, positioning Bluejay to meet future clinical and commercial demand, should its device gain market clearance. The company has also established the internal capability to produce additional antibodies as needed, providing a degree of control over a vital part of its supply chain. This move is strengthened by the use of proprietary immunogens, which supports the company's intellectual property strategy.

This manufacturing readiness is a noteworthy achievement for a development-stage diagnostics firm. By scaling up production of its core biological components, Bluejay has overcome a common and often costly hurdle that can delay or derail the commercialization of new medical devices. The company’s ongoing partnership with Japan-based contract manufacturer SanyoSeiko Co., Ltd. for the Symphony platform, combined with its search for an additional manufacturing partner for the cartridges, indicates a multi-pronged strategy to build out a robust manufacturing and supply chain infrastructure ahead of a potential product launch.

The Clinical Case for Faster Diagnosis

The core value proposition of Bluejay's Symphony IL-6 Test lies in the science of its chosen biomarker. IL-6 is considered a “first responder” cytokine, with levels rising in the blood within one to two hours of an infectious insult. This is significantly faster than commonly used biomarkers like C-reactive protein (CRP) and procalcitonin (PCT), which can take 6 to 12 hours to elevate and up to three days to peak. This time difference is critical in sepsis, where every hour of delayed treatment increases mortality risk.

The clinical utility of IL-6 as an early indicator of severe inflammation was prominently validated during the COVID-19 pandemic. In October 2020, the FDA granted an Emergency Use Authorization (EUA) to a fully automated IL-6 test from Beckman Coulter to help physicians identify patients at risk of severe inflammatory response and respiratory failure. This regulatory precedent has bolstered the scientific community's confidence in IL-6 as a valuable biomarker in critical care settings. Recent studies presented at major medical conferences have further demonstrated IL-6's superior sensitivity and specificity compared to other markers in high-risk patient groups, including children and pregnant women.

Bluejay aims to capitalize on this by offering a test that is not only accurate but also exceptionally fast. While existing hospital lab systems can measure IL-6, they often take several hours. The Symphony system’s promise of a 20-minute turnaround time at or near the point of care could enable clinicians to make faster triage and treatment decisions, potentially improving patient outcomes and optimizing the use of critical hospital resources.

The Long Road Ahead: Clinical and Regulatory Hurdles

Despite the positive manufacturing news, the Symphony system remains years away from the market. The device has not yet received clearance from the U.S. Food and Drug Administration (FDA) and faces a lengthy and capital-intensive validation process. Bluejay is currently conducting its SYMON-II pivotal clinical study to assess the test's ability to predict 28-day all-cause mortality in ICU patients. As of late 2025, the trial was approximately 50% enrolled.

According to its stated plans, and contingent on securing necessary funding, Bluejay intends to complete sample testing by late 2026 and file a 510(k) regulatory application with the FDA in the fourth quarter of 2027. This pathway is for devices that are “substantially equivalent” to an existing legally marketed device. If the review proceeds as hoped, the company is targeting potential FDA approval by the third quarter of 2028. This timeline underscores the significant development and regulatory work that remains.

A High-Stakes Financial Gamble

The journey to market is not just a clinical and regulatory race but also a financial one. As a small-cap biotech with a market capitalization of just over $2.6 million, Bluejay Diagnostics faces immense financial pressure. The company is burning through cash, reporting a net loss of $7.7 million for the 2024 fiscal year, and its stock has seen a precipitous decline over the past year.

Management has been actively raising capital to fund operations. The company secured approximately $3.8 million from warrant exercises in April 2025, followed by a $4.5 million private placement in October. However, these infusions are only a fraction of what is needed. Bluejay has estimated it must raise at least $20 million in additional capital by the end of 2027 to fund the completion of its clinical trial, the FDA submission, and other operational milestones.

This financial reality places Bluejay in a precarious position, common for development-stage companies betting on a single, high-potential asset. Its success is contingent not only on its technology proving effective but also on its ability to convince investors to continue funding its long-term vision in a competitive market. Competitors like Immunexpress, with its FDA-cleared SeptiCyte™ LAB test, and Cytovale, with its IntelliSep test, are already active in the host-response diagnostic space, creating a challenging landscape for any new entrant. For Bluejay Diagnostics, achieving this manufacturing milestone is a crucial proof point in its narrative, but the ultimate fate of its Symphony system will be determined in the clinical trials, regulatory reviews, and capital markets of the coming years.