1. Bluejay completed commercial-scale production of IL-6 antibodies. 2. Both antibody types met internal criteria for Symphony™ cartridges. 3. Production can support over nine million cartridges for clinical use. 4. FDA clearance is still needed for Symphony System marketing. 5. Forward-looking statements caution against reliance on expected outcomes.
FAQ
Why Bullish?
Successful product development in diagnostics historically boosts stock value; similar past examples include diagnostics firms like Cepheid, which saw growth after FDA approvals.
How important is it?
The completion of antibody production is a significant step, indicating future commercial viability, though regulatory approval remains a critical uncertainty.
Why Long Term?
Long-term benefits expected as Symphony System gains regulatory approval and commercial traction, similar to previous successful diagnostics launches.
Bluejay Diagnostics Completes Commercial-Scale Production of IL-6 Antibodies
ACTON, Mass., December 29, 2025 (GLOBE NEWSWIRE) — Bluejay Diagnostics, Inc. (NASDAQ: BJDX) has announced the successful completion of commercial-scale production for both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6), a crucial biomarker significant for inflammatory and critical-care applications.
Details of the Antibody Production
The company confirmed that the antibodies produced meet their stringent internal performance criteria, which include reactivity levels suitable for use in Symphony™ cartridge manufacturing. These cartridges are intended for clinical applications and potential future commercial distribution.
Bluejay has successfully generated polyclonal antibodies using a combination of third-party and internally developed immunogens. Additionally, the antibodies produced from its proprietary immunogen will support ongoing development activities, enhancing the company’s intellectual-property strategy.
Performance Characteristics of the Monoclonal Antibodies
The monoclonal antibodies have been designated for use as detection antibodies in the IL-6 assay and have shown acceptable performance in terms of binding, specificity, and signal characteristics based on initial internal testing.
- Production capacity: More than nine million Symphony cartridges.
- Current inventory: Sufficient materials confirmed to support significant clinical and commercial manufacturing needs.
- Future capabilities: Enhanced production capacity for additional antibodies as required.
Future Prospects with the Symphony™ System
Although the Symphony™ system is still under development, it is crucial to note that it remains subject to further validation and regulatory review. Bluejay Diagnostics emphasizes that there is no assurance on the timing or success of receiving the necessary regulatory clearance from the U.S. Food and Drug Administration for the Symphony to be marketed as a diagnostic product.
About Bluejay Diagnostics
Bluejay Diagnostics, Inc. is dedicated to improving patient outcomes through its innovative Symphony System, which offers a cost-effective and rapid near-patient testing platform for sepsis triage and disease progression monitoring. The company’s first product candidate, an IL-6 Test, is designed to deliver accurate and timely results within approximately 20 minutes. This rapid turnaround aims to assist healthcare professionals in making informed treatment decisions.
For further information, visit www.bluejaydx.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding Bluejay’s expected commercialization of its Symphony platform. These statements may be identified by terms like “anticipates,” “believes,” “estimates,” and similar expressions.
While these projections are based on current expectations, the actual results may differ significantly due to various factors, including market conditions. Investors are advised not to place undue reliance on these forward-looking statements, as actual future performance may vary.