What Bluejay Diagnostics does

Bluejay Diagnostics is a pre-revenue, clinical-stage medical diagnostics company developing the Symphony platform, a near-patient biomarker detection system designed to deliver quantitative clinical chemistry results in approximately 20 minutes from three drops of whole blood. The platform combines interrupted microfluidics, nanotechnology, and fluorescence enzyme immunoassay (FEIA/ELISA) methodology into a portable 16kg analyzer paired with single-use cartridges that contain all reagents and process samples without pre-processing or technician intervention. The lead product candidate, the Symphony IL-6 Test, targets sepsis triage and monitoring in critical care settings such as ICUs, emergency rooms, and LTACs, where rapid IL-6 biomarker quantification can guide time-sensitive treatment decisions.

The underlying detection technology is built on an exclusive global license (excluding Japan) from Toray Industries, supplemented by dual manufacturing partnerships with SanyoSeiko (Japan, announced October 2025) and Argonaut Manufacturing Services (United States, announced June 2026). The company has completed the SYMON-I study (results suggesting IL-6 may predict mortality in sepsis patients) and enrolled 624 patients in the SYMON-II pivotal trial toward an FDA De Novo submission. Additional pipeline assets include ALLEREYE for allergic conjunctivitis and stated future expansion potential into oncology and cardio-metabolic disease monitoring.

Bluejay is publicly traded on NASDAQ under ticker BJDX and has raised approximately $30M+ across eight equity and warrant-inducement financings between 2023 and June 2026, with most recent rounds led by H.C. Wainwright, Rodman and Renshaw, and Aegis Capital. The company reported a $6.85M net loss for FY2025 with cash of approximately $5.2M entering 2026, management has stated the existing runway extends only through approximately Q3 2026, and an additional ~$20M is required through fiscal year 2027. The business model is intended to revolve around sale of proprietary single-use test cartridges (consumables) and Symphony Analyzer hardware to hospitals and clinics via a direct sales motion upon FDA authorization, supported by collaborations such as the Blood Centers of America agreement signed February 2023. As of June 2026, the company had a market capitalization of approximately $2.25M and had executed a 1-for-4 reverse stock split in January 2026.

Name

Bluejay Diagnostics

Legal name

Bluejay Diagnostics, Inc.

Website

https://bluejaydx.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Bluejay Diagnostics is a pre-revenue, clinical-stage diagnostics company developing the Symphony platform, a portable near-patient system for rapid IL-6 biomarker testing intended to triage sepsis patients in ICUs, emergency rooms, and LTACs pending FDA De Novo clearance.

Ownership category

akta.pro rank

Product category

Point-of-Care Diagnostic Testing

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

akta.pro secondary industries

Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Point-of-care diagnostics
• Biomarker detection platform
• Sepsis triage testing
• Near-patient immunoassay
• Rapid clinical chemistry

Headquarters

HQ city

Acton

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Symphony IL-6 Test (when commercialized): Pre-revenue company developing rapid diagnostic platform. Revenue model will likely involve sale of proprietary test cartridges (consumables) and potentially the Symphony Analyzer hardware. Company is in clinical development stage pursuing FDA De Novo/510(k) clearance before commercialization.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Bluejay Diagnostics develops the Symphony platform, a near-patient biomarker detection system that combines fluorescence enzyme immunoassay (FEIA) methodology with microfluidics, nanotechnology, and interrupted fluid dynamics to deliver quantitative clinical chemistry results in approximately 20 minutes from whole blood. The platform consists of a portable Symphony Analyzer paired with single-use Symphony Cartridges containing all reagents; the lead product candidate is the Symphony IL-6 Test intended for sepsis triage and monitoring in critical care settings, with a pipeline that previously included the ALLEREYE test for allergic conjunctivitis. Products are currently labeled 'For Research Use Only' and are not yet FDA cleared or commercialized.

Product overview

Bluejay Diagnostics offers the Symphony™ platform, a near-patient biomarker detection system for critical care diagnostics. The platform consists of the Symphony Analyzer (portable fluorescence immuno-analyzer hardware) and Symphony Cartridges (single-use test devices with integrated reagents). The lead product candidate is the Symphony IL-6 Test for sepsis triage and monitoring, which uses interleukin-6 as a biomarker. Additional products include ALLEREYE™ for allergic conjunctivitis. The system provides laboratory-quality quantitative results in approximately 20 minutes using only three drops of whole blood, eliminating the need for specialized laboratory technicians or additional equipment.

Differentiator

Problem solved

Functional benefit

Brands

• Symphony: Near-patient biomarker detection platform for rapid diagnostic testing in critical care settings, providing quantitative clinical chemistry results for triage and acute care situations.
• Symphony IL-6 Test
• Allereye

Products and services

• Symphony Platform A near-patient biomarker detection platform that combines fluorescence enzyme immunoassay (FEIA) methodology with microfluidics, nanotechnology, and interrupted fluid dynamics to deliver quantitative clinical chemistry results in approximately 20 minutes from whole blood. The system consists of a portable Symphony Analyzer and single-use Symphony Cartridges with integrated reagents, intended for hospitals, ICUs, emergency rooms, LTACs, and clinics performing triage and acute care diagnostics.
• Symphony IL-6 Test Rapid interleukin-6 (IL-6) biomarker test cartridge designed for sepsis triage and monitoring in critical care settings. Uses three drops of whole blood and delivers quantitative results in approximately 20 minutes via the Symphony Analyzer. Targeted at ICUs, emergency rooms, and acute care facilities where timely sepsis diagnosis informs treatment decisions.
• ALLEREYE Point-of-care diagnostic test for allergic conjunctivitis on the Symphony platform.
• Symphony Analyzer Portable fluorescence immuno-analyzer that accepts Symphony Cartridges, designed for near-patient testing without requiring specialized laboratory technicians. Includes factory calibration (electronic, mechanical, thermal), onboard thermal printer, and optional barcode reader. Supports multiplexing of up to six samples or biomarkers.
• Symphony Cartridges Single-use diagnostic test cartridges containing all required reagents, integrating whole blood processing, precision ELISA, and waste handling. Requires only three drops of whole blood with no pre-processing or additional reagents, enabling sample-to-result testing without technician intervention.

Quantifiable outcome

• IL-6 biomarker detection in ~20 minutes (vs. traditional lab turnaround times)
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Argonaut Manufacturing ServicescoreOEM/ Whitelabel/ Licensing Partner · 2 June 2026Strategic partnership to establish scalable U.S.-based manufacturing capabilities for Symphony platform. Collaboration aims to enhance supply chain resilience, reduce reliance on overseas manufacturing and import tariffs, and support future commercialization of IL-6 Test for sepsis and distribution across the United States.
• SanyoSeikocoreOEM/ Whitelabel/ Licensing Partner · 9 October 2025Expanded strategic partnership for manufacturing and commercialization of Symphony platform. SanyoSeiko provides comprehensive support including manufacturing, quality control, regulatory, and supply chain management. Builds on earlier partnership to support broader clinical validation and market introduction.
• Blood Centers of AmericaminorStrategic or Co-development Partner · 16 February 2023Collaboration agreement to develop commercial relationships to serve unmet needs by utilizing the Symphony platform in the blood and hospital markets.
• Toray Industries, Inc.coreTechnology or Integration · 8 December 2020Collaboration agreement for developing point-of-care diagnostic test to quantify IL-6 in whole blood. Toray licensed its technology and know-how to Bluejay. Bluejay received exclusive license (except Japan) for development, marketing and manufacturing globally. Technology enables IL-6 detection without pre-treatment.

Scale indicators14 records

Recent moves4 records

Expansion highlights6 records

Direct peers

• Cytovale: Cytovale's IntelliSep is a FDA-cleared rapid cellular biomarker test for sepsis triage in the ED — directly competing with Bluejay's Symphony IL-6 on the same customer (EDs/ICUs), same use case (sepsis triage), and same speed proposition (minutes vs. hours). The most directly comparable POC sepsis diagnostic peer.
• T2 Biosystems: T2 Biosystems develops T2Bacteria and T2Candida rapid direct-from-blood molecular diagnostics for sepsis, marketed to the same hospital customer base and competing on time-to-result vs. blood culture. Both target sepsis diagnostics at the same hospital labs/ICUs, though T2 uses molecular rather than immunoassay technology.

Emerging players

• Inflammatix: Inflammatix is developing HostDx, a host-response rapid test for acute infections and sepsis that uses immune-transcriptional signatures. Competes with Bluejay in sepsis triage at point-of-care and is similarly pre-commercial, making it a relevant emerging competitor for the same clinical and commercial audience.
• EKF Diagnostics: EKF Diagnostics develops and sells POC clinical chemistry and biomarker analyzers (e.g., QuikRead, DiaSpect) primarily to smaller hospitals, clinics, and emerging markets — directly overlapping with Bluejay's stated target of LTACs, smaller hospitals, and clinics that have been priced out of central-lab platforms.

Broad incumbents

• QuidelOrtho: QuidelOrtho's Triage family (e.g., Triage BNP, Triage MeterPro) is an established rapid POC immunoassay platform sold to hospitals and EDs. It competes with Symphony as a broad incumbent with installed instrumentation, sales force, and FDA-cleared menus, though it does not target IL-6 specifically.
• Abbott Point of Care: Abbott's i-STAT and Alinity ci-series are dominant POC clinical chemistry/immunoassay analyzers deployed across US hospitals, ICUs, and EDs. Represents the largest incumbent that Bluejay will compete with on hospital rapid diagnostic menus and connectivity infrastructure.
• bioMérieux: bioMérieux's VIDAS and mini-VIDAS are widely deployed immunoassay analyzers used for clinical chemistry and biomarker testing (including procalcitonin for sepsis) in hospitals. A large established incumbent in the same POC/central-lab immunoassay space Bluejay targets.
• Siemens Healthineers: Siemens' epoc blood analysis system and Atellica clinical chemistry/immunoassay platform serve hospitals and ICUs with rapid POC and central-lab testing. A broad incumbent POC diagnostics competitor with established sales channels and integration with hospital IT.
• Roche Diagnostics: Roche's cobas family of clinical chemistry and immunoassay analyzers is a market-leading central-lab platform, and Roche also has POC presence. While Bluejay competes on speed and footprint rather than menu breadth, Roche represents the dominant incumbent whose installed base Bluejay would seek to displace at the ED/ICU POC.

Others

• Mesa Labs: Mesa Labs (now part of Mettler-Toledo's related IVD QC business) manufactures IVD quality controls, calibrators, and proficiency testing materials used by clinical labs and IVD manufacturers. Comparable not as a competitor but as a supplier/ecosystem participant in the IVD consumables value chain Bluejay operates in.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks1 record

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bluejay-diagnostics

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds8 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Bluejay Diagnostics