<p>马萨诸塞州阿克顿，2025 年 12 月 29 日（GLOBE NEWSWIRE）-- Bluejay Diagnostics, Inc.（纳斯达克：BJDX）（“Bluejay” 或 “公司”）宣布已完成针对白细胞介素-6（IL-6）的多克隆和单克隆抗体的商业规模生产，该生物标志物与炎症和重症护理应用相关。</p>
<p>公司表示，多克隆和单克隆抗体均符合内部性能标准，包括反应性，可用于用于临床和潜在未来商业应用的 Symphony™卡匣制造。</p>
<p>Bluejay 已使用第三方和内部开发的免疫原生成多克隆抗体。公司打算利用其专有免疫原生产的抗体进行持续的开发活动，以支持其知识产权战略。公司生产的单克隆抗体，指定用于 IL-6 检测中的检测抗体，已根据迄今为止进行的内部测试显示出可接受的结合性、特异性和信号性能特征，适用于其预期的诊断用途。</p>
<p>根据当前的抗体库存，Bluejay 估计其有足够的材料支持生产超过九百万个用于临床和商业制造目的的 Symphony 卡匣。公司还建立了根据需要生产额外抗体的能力。</p>
<p><em>公司指出，Symphony™仍在开发中，需进一步验证、监管审查和批准，无法保证这些活动的时间或成功。</em></p>
<p><strong>关于 Bluejay Diagnostics：</strong></p>
<p>Bluejay Diagnostics, Inc.是一家医疗诊断公司，专注于利用其 Symphony 系统改善患者结果，该系统是一种经济高效、快速、近患者的检测系统，用于脓毒症分流和疾病进展监测。Bluejay 尚未获得 Symphony 系统的监管批准，我们需要从美国食品药品监督管理局获得监管授权，才能在美国将 Symphony 作为诊断产品进行市场销售。Bluejay 的首个产品候选者是针对脓毒症的 IL-6 检测，旨在提供约 20 分钟内从 “样本到结果” 的准确、可靠结果，以帮助医疗专业人员做出更早和更好的分流/治疗决策。更多信息请访问 www.bluejaydx.com。</p>
<p><strong>前瞻性声明：</strong></p>
<p>本新闻稿包含公司认为是《私人诉讼改革法》意义上的 “前瞻性声明” 的陈述。本新闻稿中的前瞻性声明包括但不限于与 Bluejay 的 Symphony 平台商业化状态相关的陈述。前瞻性声明可以通过诸如 “预期”、“相信”、“估计”、“期望”、“打算”、“可能”、“计划”、“项目”、“寻求”、“应该”、“建议”、“将” 等类似表达来识别。公司基于其对未来事件的当前预期和预测作出这些前瞻性声明，然而，实际结果或事件可能与公司所披露或暗示的计划、意图和期望有实质性差异。这些声明仅为预测，涉及已知和未知的风险、不确定性及其他因素，包括市场和其他条件，以及在我们向证券交易委员会（“SEC”）提交的 2024 财年 10-K 表格第 1A 项 “风险因素” 中讨论的因素，以及在其 2025 年 3 月 31 日、2025 年 6 月 30 日和 2025 年 9 月 30 日的 10-Q 季度报告第 1A 项 “风险因素” 中讨论的因素。您不应对这些前瞻性声明过于依赖，因为它们受到风险和不确定性的影响，未来期间的实际结果和表现可能不会发生，或可能与本发布中前瞻性声明所暗示的任何未来结果或表现有实质性不同。本新闻稿的内容截至上述日期。公司没有义务更新任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非法律要求。公司明确声明不承担更新或修订本声明中任何前瞻性声明的义务，以反映公司对结果的期望或任何未来事件的变化，除非法律要求。</p>
<p><strong>投资者联系：</strong></p>
<p>Neil Dey</p>
<p>Bluejay Diagnostics, Inc.</p>
<p>neil.dey@bluejaydx.com</p>
<p>978-631-0310</p>
<p><strong><em>网站：www.bluejaydx.com</em></strong></p>
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<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/ODVmODhmYTctYzMxNy00MjA4LThhMmMtZWY0Nzc4ZmQ1Yjk4LTEyMzQ3MDAtMjAyNS0xMi0yOS1lbg==/tiny/Bluejay-Diagnostics-Inc-.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/ODVmODhmYTctYzMxNy00MjA4LThhMmMtZWY0Nzc4ZmQ1Yjk4LTEyMzQ3MDAtMjAyNS0xMi0yOS1lbg==/tiny/Bluejay-Diagnostics-Inc-.png"/></p>

BJDX

<p>Bluejay Diagnostics, Inc. 已完成 IL-6 抗体的商业规模生产，满足临床应用的内部性能标准。公司估计库存足够生产超过九百万个 Symphony 碳墨盒。Symphony 系统旨在快速检测脓毒症，目前仍在开发中，需获得 FDA 批准后才能上市。Bluejay 强调，发布中的前瞻性声明受到风险和不确定性的影响，实际结果可能与预期有所不同</p>

<p>ACTON, Mass., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”) announced that it has completed commercial-scale production of both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6), a biomarker relevant to inflammatory and critical-care applications.</p>
<div class="lb-trans"><p>马萨诸塞州阿克顿，2025 年 12 月 29 日（GLOBE NEWSWIRE）-- Bluejay Diagnostics, Inc.（纳斯达克：BJDX）（“Bluejay” 或 “公司”）宣布已完成针对白细胞介素-6（IL-6）的多克隆和单克隆抗体的商业规模生产，该生物标志物与炎症和重症护理应用相关。</p>
</div><p>The Company stated that both polyclonal and monoclonal antibodies met internal performance criteria, including reactivity, for use in Symphony™ cartridge manufacturing intended for clinical and potential future commercial applications.</p>
<div class="lb-trans"><p>公司表示，多克隆和单克隆抗体均符合内部性能标准，包括反应性，可用于用于临床和潜在未来商业应用的 Symphony™卡匣制造。</p>
</div><p>Bluejay has generated polyclonal antibodies using both third-party and internally developed immunogens. The Company intends to utilize antibodies produced from its proprietary immunogen for ongoing development activities in support of its intellectual-property strategy. The monoclonal antibodies produced by the Company, designated for use as detection antibodies in the IL-6 assay, have demonstrated acceptable binding, specificity, and signal performance characteristics for their intended diagnostic use, based on internal testing conducted to date.</p>
<div class="lb-trans"><p>Bluejay 已使用第三方和内部开发的免疫原生成多克隆抗体。公司打算利用其专有免疫原生产的抗体进行持续的开发活动，以支持其知识产权战略。公司生产的单克隆抗体，指定用于 IL-6 检测中的检测抗体，已根据迄今为止进行的内部测试显示出可接受的结合性、特异性和信号性能特征，适用于其预期的诊断用途。</p>
</div><p>Based on current antibody inventory, Bluejay estimates that it has sufficient material to support production of more than nine million Symphony cartridges for clinical and commercial manufacturing purposes. The Company has also established the capability to produce additional antibodies as needed.</p>
<div class="lb-trans"><p>根据当前的抗体库存，Bluejay 估计其有足够的材料支持生产超过九百万个用于临床和商业制造目的的 Symphony 卡匣。公司还建立了根据需要生产额外抗体的能力。</p>
</div><p><em>The Company noted that Symphony™ remains under development and subject to further validation, regulatory review, and clearance, and that there can be no assurance regarding the timing or success of these activities.</em></p>
<div class="lb-trans"><p><em>公司指出，Symphony™仍在开发中，需进一步验证、监管审查和批准，无法保证这些活动的时间或成功。</em></p>
</div><p><strong>About Bluejay Diagnostics:</strong></p>
<div class="lb-trans"><p><strong>关于 Bluejay Diagnostics：</strong></p>
</div><p>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.</p>
<div class="lb-trans"><p>Bluejay Diagnostics, Inc.是一家医疗诊断公司，专注于利用其 Symphony 系统改善患者结果，该系统是一种经济高效、快速、近患者的检测系统，用于脓毒症分流和疾病进展监测。Bluejay 尚未获得 Symphony 系统的监管批准，我们需要从美国食品药品监督管理局获得监管授权，才能在美国将 Symphony 作为诊断产品进行市场销售。Bluejay 的首个产品候选者是针对脓毒症的 IL-6 检测，旨在提供约 20 分钟内从 “样本到结果” 的准确、可靠结果，以帮助医疗专业人员做出更早和更好的分流/治疗决策。更多信息请访问 www.bluejaydx.com。</p>
</div><p><strong>Forward-Looking Statements:</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明：</strong></p>
</div><p>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 the status of Bluejay’s commercialization of its 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, June 30, 2025 and September 30, 2025, filed with the SEC on May 13, 2025, August 7, 2025 and November 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.</p>
<div class="lb-trans"><p>本新闻稿包含公司认为是《私人诉讼改革法》意义上的 “前瞻性声明” 的陈述。本新闻稿中的前瞻性声明包括但不限于与 Bluejay 的 Symphony 平台商业化状态相关的陈述。前瞻性声明可以通过诸如 “预期”、“相信”、“估计”、“期望”、“打算”、“可能”、“计划”、“项目”、“寻求”、“应该”、“建议”、“将” 等类似表达来识别。公司基于其对未来事件的当前预期和预测作出这些前瞻性声明，然而，实际结果或事件可能与公司所披露或暗示的计划、意图和期望有实质性差异。这些声明仅为预测，涉及已知和未知的风险、不确定性及其他因素，包括市场和其他条件，以及在我们向证券交易委员会（“SEC”）提交的 2024 财年 10-K 表格第 1A 项 “风险因素” 中讨论的因素，以及在其 2025 年 3 月 31 日、2025 年 6 月 30 日和 2025 年 9 月 30 日的 10-Q 季度报告第 1A 项 “风险因素” 中讨论的因素。您不应对这些前瞻性声明过于依赖，因为它们受到风险和不确定性的影响，未来期间的实际结果和表现可能不会发生，或可能与本发布中前瞻性声明所暗示的任何未来结果或表现有实质性不同。本新闻稿的内容截至上述日期。公司没有义务更新任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非法律要求。公司明确声明不承担更新或修订本声明中任何前瞻性声明的义务，以反映公司对结果的期望或任何未来事件的变化，除非法律要求。</p>
</div><p><strong>Investor Contact:</strong></p>
<div class="lb-trans"><p><strong>投资者联系：</strong></p>
</div><p>Neil Dey</p>
<div class="lb-trans"><p>Neil Dey</p>
</div><p>Bluejay Diagnostics, Inc.</p>
<div class="lb-trans"><p>Bluejay Diagnostics, Inc.</p>
</div><p>neil.dey@bluejaydx.com</p>
<div class="lb-trans"><p>neil.dey@bluejaydx.com</p>
</div><p>978-631-0310</p>
<div class="lb-trans"><p>978-631-0310</p>
</div><p><strong><em>Website: www.bluejaydx.com</em></strong></p>
<div class="lb-trans"><p><strong><em>网站：www.bluejaydx.com</em></strong></p>
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Bluejay Diagnostics 宣布完成商业规模的 IL-6 抗体生产 | BJDX 股票新闻