Bluejay Diagnostics, Inc.
Bluejay Diagnostics is focused on developing easy-to-use, near-patient medical diagnostics tests to improve healthcare outcomes. They are developing rapid, cost-effective, point-of-care tests and devices that provide timely healthcare access, especially in critical care settings. Their flagship product, Symphony, is a near-patient biomarker detection platform designed to aid in triage, diagnosis, and monitoring of disease progression, including applications for COVID-19 and sepsis. The company collaborates with industry leaders like Toray Industries and Blood Centers of America, and has a dedicated leadership team and board of directors committed to advancing healthcare through innovation.
Industries
Nr. of Employees
small (1-50)
Bluejay Diagnostics, Inc.
Acton, Massachusetts, United States, North America
Products
Near-patient fluorescence immuno-analyzer platform (cartridge-based)
A portable diagnostic analyzer that performs fluorescence immunoassays using single-use cartridges with integrated reagents to deliver quantitative biomarker results from a single clinical sample in a sample-to-result format.
Near-patient fluorescence immuno-analyzer platform (cartridge-based)
A portable diagnostic analyzer that performs fluorescence immunoassays using single-use cartridges with integrated reagents to deliver quantitative biomarker results from a single clinical sample in a sample-to-result format.
Services
Collaborative development and licensing of point-of-care assays
Co-development, licensing, and commercialization collaborations with external technology licensors and distribution partners to develop point-of-care biomarker tests.
Clinical study execution and regulatory filing support
Conduct of prospective multicenter clinical studies and preparation of regulatory filing packages for FDA engagement (pre-submission and De Novo planning); generating clinical validation data for near-patient assays.
Collaborative development and licensing of point-of-care assays
Co-development, licensing, and commercialization collaborations with external technology licensors and distribution partners to develop point-of-care biomarker tests.
Clinical study execution and regulatory filing support
Conduct of prospective multicenter clinical studies and preparation of regulatory filing packages for FDA engagement (pre-submission and De Novo planning); generating clinical validation data for near-patient assays.
Expertise Areas
- Point-of-care diagnostic platform development
- Cartridge-based sample-to-result assay integration
- Microfluidics-enabled assay engineering
- Analytical assay development for cytokine biomarkers (IL-6)
Key Technologies
- Microfluidics
- Nanotechnology-enhanced assay components
- Fluorescence immunoassays
- ELISA-based assay formats