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.
360 Massachusetts Avenue, Suite 203 Acton, MA 01720
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
Co-development, licensing, and commercialization collaborations with external technology licensors and distribution partners to develop point-of-care biomarker tests.
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.
Co-development, licensing, and commercialization collaborations with external technology licensors and distribution partners to develop point-of-care biomarker tests.
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
News & Updates
The FDA has agreed to consider Bluejay’s plan for a De Novo submission for the Symphony IL-6 Test, a key step towards regulatory approval.
Bluejay announced a transaction to raise approximately $3.7 million in gross proceeds to fund further development.
The company has completed clinical studies for its Symphony IL-6 Test, with results to be published at the 2022 AACC Annual Scientific Meeting.
The FDA has agreed to consider Bluejay’s plan for a De Novo pathway for the Symphony IL-6 Test.
Bluejay announced a collaboration with Blood Centers of America to develop the Symphony platform for blood and hospital markets.
Kenneth Fisher joined Bluejay as CFO, reporting to the CEO, to support financial strategy and growth.
The FDA has agreed to consider Bluejay’s plan for a De Novo submission for the Symphony IL-6 Test, a key step towards regulatory approval.
Bluejay announced a transaction to raise approximately $3.7 million in gross proceeds to fund further development.
The company has completed clinical studies for its Symphony IL-6 Test, with results to be published at the 2022 AACC Annual Scientific Meeting.
The FDA has agreed to consider Bluejay’s plan for a De Novo pathway for the Symphony IL-6 Test.
Bluejay announced a collaboration with Blood Centers of America to develop the Symphony platform for blood and hospital markets.
Kenneth Fisher joined Bluejay as CFO, reporting to the CEO, to support financial strategy and growth.