Bluejay Diagnostics and SanyoSeiko Expand Strategic Partnership to Advance Commercialization of Symphony Platform
Bluejay Diagnostics (NASDAQ: BJDX) and SanyoSeiko agreed on Oct. 9, 2025 to amend their Master Service Agreement and Master Supply Agreement to expand SanyoSeiko’s role in commercializing the Symphony near-patient testing platform.
Under statements of work already provided, SanyoSeiko will provide end-to-end support including manufacturing redevelopment for analyzers and cartridges, hardware/software/design updates, raw material sourcing, vendor compliance, kit assembly, labeling, packaging, shipping, quality control, regulatory and quality management support, and equipment storage and maintenance. The companies say the amended agreements aim to strengthen supply chain resilience, secure production capacity, and advance readiness for broader clinical validation and market introduction.
Bluejay Diagnostics (NASDAQ: BJDX) e SanyoSeiko hanno concordato il 9 ottobre 2025 di modificare il loro Master Service Agreement e Master Supply Agreement per espandere il ruolo di SanyoSeiko nella commercializzazione della piattaforma di testing near-patient Symphony.
Sulla base delle dichiarazioni di lavoro già fornite, SanyoSeiko fornirà supporto end-to-end includendo la rivalutazione della produzione per analizzatori e cartucce, aggiornamenti hardware/software/progettuali, reperimento di materie prime, conformità dei fornitori, assemblaggio dei kit, etichettatura, imballaggio, spedizioni, controllo qualità, supporto regolatorio e gestione della qualità, oltre a stoccaggio e manutenzione delle apparecchiature. Le aziende affermano che gli accordi modificati mirano a rafforzare la resilienza della catena di approvvigionamento, a garantire la capacità di produzione e a avanzare la preparazione per una validazione clinica più ampia e l'introduzione sul mercato.
Bluejay Diagnostics (NASDAQ: BJDX) y SanyoSeiko acudieron el 9 de octubre de 2025 para enmendar su Master Service Agreement y Master Supply Agreement con el fin de ampliar el papel de SanyoSeiko en la comercialización de la plataforma de pruebas cerca del paciente Symphony.
Según las declaraciones de trabajo ya proporcionadas, SanyoSeiko brindará apoyo de extremo a extremo, incluyendo la redevolución de la fabricación para analizadores y cartuchos, actualizaciones de hardware/software/diseño, suministro de materias primas, cumplimiento de proveedores, montaje de kits, etiquetado, embalaje, envío, control de calidad, apoyo regulatorio y gestión de la calidad, así como almacenamiento y mantenimiento de equipos. Las empresas dicen que los acuerdos enmendados buscan fortalecer la resiliencia de la cadena de suministro, asegurar la capacidad de producción y avanzar en la preparación para una validación clínica más amplia y la introducción al mercado.
Bluejay Diagnostics (나스닥: BJDX)와 SanyoSeiko는 2025년 10월 9일에 Master Service Agreement와 Master Supply Agreement를 개정하여 근접 환자 테스트 플랫폼 Symphony의 상용화에서 SanyoSeiko의 역할을 확대하기로 합의했습니다.
이미 제공된 업무 명세에 따라 SanyoSeiko는 분석기와 카트리지의 제조 재개발, 하드웨어/소프트웨어/설계 업데이트, 원자재 조달, 공급업체 컴플라이언스, 키트 조립, 표기, 포장, 선적, 품질 관리, 규제 및 품질 관리 지원, 장비 보관 및 유지보수를 포함한 엔드-투-엔드 지원을 제공할 것입니다. 양사는 개정된 계약이 공급망 회복력 강화, 생산 능력 확보, 더 넓은 임상 검증 및 시장 도입 준비를 촉진하는 것을 목표로 한다고 말합니다.
Bluejay Diagnostics (NASDAQ : BJDX) et SanyoSeiko ont convenu le 9 octobre 2025 de modifier leur Master Service Agreement et Master Supply Agreement afin d'élargir le rôle de SanyoSeiko dans la commercialisation de la plateforme de tests proche du patient Symphony.
Selon les statements of work déjà fournis, SanyoSeiko fournira un soutien de bout en bout incluant le redéveloppement de la fabrication des analyseurs et des cartouches, les mises à jour hardware/software/design, l'approvisionnement en matières premières, la conformité des fournisseurs, l'assemblage des kits, l'étiquetage, l'emballage, l'expédition, le contrôle qualité, le soutien réglementaire et la gestion de la qualité, ainsi que le stockage et la maintenance des équipements. Les entreprises affirment que les accords modifiés visent à renforcer la résilience de la chaîne d'approvisionnement, à sécuriser la capacité de production et à faire avancer la préparation à une validation clinique plus large et à une introduction sur le marché.
Bluejay Diagnostics (NASDAQ: BJDX) und SanyoSeiko haben am 9. Oktober 2025 vereinbart, ihren Master Service Agreement und Master Supply Agreement zu ändern, um die Rolle von SanyoSeiko bei der Vermarktung der Near-Patient-Testplattform Symphony zu erweitern.
Nach bereits vorgelegten Leistungsbeschreibungen wird SanyoSeiko End-to-End-Unterstützung bieten, einschließlich der Neubaufertigung für Analyzer und Cartridges, Hardware-/Software-/Design-Updates, Rohstoffbeschaffung, Lieferanten-Compliance, Kit-Zusammenbau, Kennzeichnung, Verpackung, Versand, Qualitätskontrollen, regulatorische und Qualitätsmanagement-Unterstützung sowie Lagerung und Wartung der Ausrüstung. Die Parteien sagen, die geänderten Vereinbarungen zielen darauf ab, die Widerstandsfähigkeit der Lieferkette zu stärken, die Produktionskapazität zu sichern und die Bereitschaft für eine breitere klinische Validierung und Markteinführung voranzutreiben.
Bluejay Diagnostics (تداول ناسداك: BJDX) و
وفقًا لبيانات العمل المقدمة بالفعل، ستقدم SanyoSeiko دعماً شاملاً من البداية إلى النهاية بما في ذلك إعادة تطوير التصنيع للمحولات والشرائط، وتحديثات الأجهزة/البرمجيات/التصميم، وتوفير المواد الخام، والامتثال للموردين، وتجميع العلب، ووضع الملصقات والتغليف والشحن، ومراقبة الجودة، والدعم التنظيمي وإدارة الجودة، بالإضافة إلى التخزين وصيانة المعدات. تقول الشركات إن الاتفاقيات المعدلة تهدف إلى تعزيز مرونة سلسلة التوريد وتأمين القدرة الإنتاجية والتقدم في الاستعداد لتوثيق سريري أوسع وإدخاله إلى السوق.
Bluejay Diagnostics (纳斯达克: BJDX) 与 SanyoSeiko 于 2025 年 10 月 9 日就修改其 Master Service Agreement 和 Master Supply Agreement 达成一致，以扩大 SanyoSeiko 在商业化近端患者测试平台 Symphony 的角色。
根据已提供的工作说明，SanyoSeiko 将提供端到端的支持，包括分析仪和试剂盒的制造再开发、硬件/软件/设计更新、原材料采购、供应商合规、试剂盒组装、标签、包装、运输、质量控制、监管及质量管理支持，以及设备的存储与维护。双方表示，修订后的协议旨在提升供应链韧性、确保产能，并推进更广泛的临床验证和市场引入的准备工作。
- Amended manufacturing agreements executed on Oct. 9, 2025
- SanyoSeiko to provide end-to-end manufacturing and quality support
- Expanded role targets improved supply chain resilience and production capacity
- Symphony still requires broader clinical validation before market launch
- Greater operational reliance on a single contract manufacturer increases concentration risk
Insights
Expanded contract-manufacturing deal strengthens Symphony commercialization pathway, improving production readiness and supply-chain control.
Bluejay Diagnostics expanded its Master Service and Supply Agreements with SanyoSeiko to have SanyoSeiko provide end-to-end manufacturing, sourcing, fulfillment, quality, regulatory support and equipment services for the Symphony platform, advancing readiness for broader clinical validation and market introduction.
The move reduces execution risk by consolidating hardware, cartridge and supply responsibilities with an experienced medical-device manufacturer, but outcomes still depend on successful redevelopment, regulatory acceptances, and validated scale-up processes. Key operational risks include design-change validation, vendor qualification, and quality-system integration between parties.
Watch for completion of stated redevelopment milestones, regulatory filings/clearances, and initial commercial production runs over the next 6–18 months (targeting broader clinical validation and market introduction around
ACTON, Mass. and YAMANASHI, Japan, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”), a medical diagnostics company focused on developing rapid near-patient testing solutions for critical care, today announced that it has entered into an Agreement to Amend the Master Service Agreement and the Master Supply Agreement with SanyoSeiko Co., Ltd. (“SanyoSeiko”), a Japan-based contract manufacturer specializing in medical devices and precision engineering.
The amended agreement was entered into in connection with Bluejay expanding SanyoSeiko’s role in helping to commercialize Bluejay’s Symphony platform, a near-patient testing system designed to provide rapid and reliable results for key biomarkers such as IL-6 in sepsis management.
Pursuant to statements of work that Bluejay has begun providing to Sanyoseiko under this agreement, Sanyoseiko will provide end-to-end support for the Symphony platform, including supporting the manufacturing redevelopment process for analyzers and cartridges (with hardware, software, and design updates), managing raw material sourcing and vendor compliance, and serving as Bluejay’s contract manufacturing organization for analyzers, cartridges, and related components. In this capacity, Sanyoseiko will oversee fulfillment, kit assembly, labeling, packaging, shipping, and quality control of manufactured products, while also providing regulatory and quality management support, and equipment storage and maintenance.
“This expanded partnership marks a key milestone in Bluejay’s commercialization strategy for the Symphony platform,” said Neil Dey, CEO of Bluejay. “By formalizing SanyoSeiko’s role as manufacturing partner, we strengthen our supply chain resilience, secures high-quality production capacity, and advances readiness for broader clinical validation and market introduction.”
“We are excited to extend our partnership with Bluejay Diagnostics,” added Futoshi Shirakawa, CEO of SanyoSeiko Co., Ltd. “Our technical capabilities and manufacturing experience will support the successful commercialization of Symphony, a platform with the potential to make a meaningful impact in critical care diagnostics worldwide.”
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from ‘sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com.
About SanyoSeiko Co., Ltd.
SanyoSeiko Co., Ltd., headquartered in Yamanashi, Japan, is a precision engineering and contract manufacturing company with expertise in medical device design, development, and production. The company provides high-quality solutions in hardware, software, packaging, and fulfillment for global healthcare partners. More information is available at https://sanyoseiko.co.jp/en/
Forward-Looking Statements:
This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements pertaining to Bluejay’s relationship with SanyoSeiko and the work SanyoSeiko has been requested to undertake for Bluejay supporting the manufacturing process redevelopment, supply chain management, and manufacturing of Bluejay’s Symphony platform. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,” “will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors” in our Form 10-K for the fiscal year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025 and June 30, 2025, filed with the SEC on May 13, 2025 and August 7, 2025, respectively. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law.
Investor Contact:
Neil Dey
Bluejay Diagnostics, Inc.
neil.dey@bluejaydx.com
978-631-0310
Website: www.bluejaydx.com
FAQ
What did Bluejay (BJDX) announce on October 9, 2025 about SanyoSeiko?
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Does the Oct. 9, 2025 agreement mean Symphony is commercially available now?
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